Source: http://www.compliance4all.com/control/webinarsearch?type=WEBINAR_LIVE
Timestamp: 2017-02-23 13:52:55
Document Index: 760949991

Matched Legal Cases: ['arts 210', 'arts 210', 'art 11', 'art 820', 'art 11', 'art 11']

Webinar Search Results : 133 Upcoming webinars found. Wednesday,
10:00 AM PST | 01:00 PM EST Duration:60 Minutes
by: Anna Longwell The Role of FDA in Health Care Software Regulations and Development
This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device. View Details Wednesday,
by: Stuart Gardner Project Management - Auditing Problem Projects
Every project undertaken is not a guaranteed success; there are many things that can and do go wrong. Overly optimistic budgets or underfunded projects can result in shortcuts or unrealistic pressures on those working on the project. Staff or resources lacking the skills to work on the project see the assignment as a fast track to promotion and may not be willing to admit they can not handle the project, projects escalated to be done quickly may result in shoddy workmanship, resources pulling on time constraints can stretch employees to thin, opposition may even exist that is looking to have the project fail - yes sabotage is more common than many will admit to. View Details Wednesday,
10:00 AM PST | 01:00 PM EST Duration:90 Minutes
by: Susanne Manz Essentials of Validation -IQ,OQ,PQ
View Details Thursday,
by: Ray Graber Consumer E-Payments Complying with Auditor's Standards Part II-Specific Payments Types
The procedures provided in this session should not be construed as requirements for control implementation. The selection of controls and control implementation should be guided by the risk profile of the institution. We will discuss procedures that provide additional validation verifying the effectiveness of a financial institution's internal control processes over ACH processing, EFT/POS network processing, check item processing, electronic banking-related retail payments processing, and bankcard processing, clearance, and settlement.
by: Louis Angelucci Similarities and Differences Between an FDA and MHRA Audit
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences. View Details Thursday,
by: Denise Cicchella Auditing Enterprise Risk Management
In 2004, the Committee of Sponsoring Organizations of the Tread way Commission (COSO), issued a principle-based guidance on designing and implementing an effective enterprise-wide approach to risk management. This guidance defines essential components - such as risk appetite, risk tolerance and portfolio view, provides guidance using common principles, and provides counseling and strategy for an effective program. View Details Friday,
by: Jd Marhevko Predictive Warranty using Paynter Charts
This session shows practitioners how to develop and create a Paynter Chart for predictive warranty management. Attendees will see how to actively utilize representative return data, observe the construction of a sample Paynter and then observe the results of the predictive analysis. View Details Monday,
by: Dennis Taylor Mastering Excel: How to Create ad hoc and Date Based Groupings within a PivotTable PivotTable capabilities are enormous; among its many tools and features View Details Monday,
by: James Thatcher Motivation for EHS practitioners
This presentation is designed to maintain the high level of motivation EHS practitioners need in order to stay effective.
The presentation helps us remember View Details Tuesday,
by: Mike Thomas Excel Managing Lists and Databases
If you think that Excel is all about working with numbers then think again. More and more people are turning to Excel to help them to manage list-based and tabular data.In many cases they receive, download or import data from elsewhere and before that data can be used within their business and treated as a credible source of information, it needs be seriously checked and cleaned duplicate entries, non printing characters, extra spaces and capitalisation inconsistencies are all too often present in downloaded and imported data. In this session, you'll learn how to deal with and fix all these issues. View Details Tuesday,
by: Edwin Waldbusser Human Factors Usability Studies following ISO62366 and the new FDA Guidance
Human Factors Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating theeffectiveness of the studies will be explained. The various types and methods of human factors analysis will beexplained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document. View Details Tuesday,
by: David Dills Interfacing Design Verification, Process Validation and Design Validation
There is confusion between the requirements for Design Verification, Process Validation and Design Validation. While each of these processes has its own requirements, they do not stand alone, they are linked together. As this linkage is not well understood, it is the source of FDA observations and potential release of products that do not meet requirements.
View Details Tuesday,
by: Thomas E. Colonna FDA Regulation of Dietary Supplements
by: Heath Suddleson Dealing with Performance Issues
It is just a fact of life that someone on your team, whether you selected them or whether they were assigned to you will be a non-performer. This may be because they are simply not performing to the level desired or it may be an issue of time management, or even an issue of motivation. View Details Wednesday,
by: Greta Hicks Avoid IRS Notices By Using The Free IRS Tin Matching Program
Any company that submits IRS Forms 1099 to the IRS can possibly benefit from using the IRS Taxpayer Identification Number (TIN) Matching program. The program is a free service included in IRS e-services. Any authorized person can access e-services and submit payees for the matching process. The IRS will not tell you the correct TIN but they will let you know that the TIN and Name combination you submitted is incorrect.
by: Jerry Dalfors cGMP Application for Design & Operation
This presentation is intended to help manufacturers implement cGMP quality systems and risk management approaches during commercial development and operations after the initial preclinical studies, to meet the requirements of the FDA's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211).The FDA requires comprehensive quality systems highlighting the company's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs as well as medical devices, including biological drug products. This program also explains how manufacturers implementing good manufacturing practices managed by quality systems can be in the best compliance with parts 210 and 211. View Details Thursday,
by: Steven Wachs Demonstrating Product Reliability - Sample Sizes and Testing Times
by: William Levinson Introduction to Statistical Process Control
All manufacturing processes include random variation in part dimensions, which is why specifications include a tolerance width (lower and upper specification limits) between which the product is acceptable and will interchange with other parts during assembly. The analogy of a gun target can be used to teach this concept, and the handouts include a Visual Basic program that simulates gun targets side by side with histograms and control charts. Accuracy means that the gun is aimed at the bulls-eye (nominal, halfway between the specification limits) while variation reflects the spread in the shots. A rifle can represent a capable process, while a musket illustrates a non-capable process.
by: Michael Brodsky Quality Control for Analytical Materials used in Microbiology Laboratories To develop appropriate Quality Control Practices and acceptability criteria to evaluate the performance of analytical materials for laboratory use.
by: Jd Marhevko Calibrating the Human Gage: Attribute Agreement Analysis
A review of basic AAA analysis. Will cover the 3 basic types of agreements: Agreement with oneself, Agreement to a peer, Agreement to the standard. Both the "Statistical AAA" and the Kappa value will be reviewed. Confidence levels for the result bands will also be reviewed. Incorporation of AAA into the Control Plan and frequency of "calibration" will be reviewed. View Details Tuesday,
by: John N. Zorich Understanding, Calculating, and Using Statistical Power
Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun. View Details Wednesday,
by: Robert Michalik FDA - Legal Writing Skills that Result in Effective Regulatory Submissions
Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments. View Details Wednesday,
by: John E Lincoln Verification vs.Validation-Product,Process or Equipment and QMS Software
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world" View Details Thursday,
by: Jerry Lanese Laboratory Investigation of Out-of-Specification Results
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results. View Details Thursday,
by: Anna Longwell A second look at 510(k) changes
The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k). View Details Thursday,
by: Mike Thomas Get Organised with Microsoft Outlook
If you're like millions of other business professionals, you probably use Microsoft Outlook every day to manage your email, calendar and to do's. It's available for Windows, Mac, mobile and there's even a web version. So there's no excuse not to be organised. Or so the theory goes. The reality is email overload, missed deadlines and calendars so full you have no room to breathe
View Details Friday,
11:00 AM PST | 02:00 PM EST Duration:90 Minutes
by: Miles Hutchinson How to Analyze Financial Statements
Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales.Use our proven model to quickly assess the financial condition and results of operations of any business using trend and ratio analysis.Join C-suites and business analysts from around the country and empower your team to maximize the benefit from your crystal clear understanding of the numbers.
View Details Monday,
by: Mike Morley IFRS Oil,Mining,Gas
IFRS #6 requires that companies that have assets used for exploration and evaluation of mineral resources must issue IFRS compliant financial statements. As an accounting professional, you should be familiar with exactly what these new standards consist of, and what they mean for companies in the oil, gas and mining industries. This presentation will help you become acquainted with the latest information regarding IFRS for companies in the resource sector.
by: Jose Mora 21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
by: William Levinson Introduction to Design of Experiments
The purpose of a designed experiment is to distinguish between random chance (luck) and genuine effects of an experimental treatment versus a control, or genuine differences between choices of materials, machines,methods, or other factors from the familiar cause and effect diagram. That is, if an improvement team identifies the choice of material,e.g. from one of three suppliers,as a possible factor that affects the outgoing quality,DOE can prove beyond a quantifiable reasonable doubt that it does. This reasonable doubt is known as the significance level in hypothesis testing.
by: Edwin Waldbusser Medical Device engineering Change Control
This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. The difference between pre release and post release change control will be explained. Methods to control the transfer and approval of changes between the company and its suppliers or contract manufacturers will be explained. Change control forms will be provided and described in detail. View Details Tuesday,
by: John N. Zorich Normality Tests and Normality Transformations: Explanations, Justifications, and Uses
Normality Tests and normality transformations are a combination of graphical and numerical methods that have been in use for many decades. These methods are essential to apply whenever a statistical test or method is used whose fundamental assumption is that the inputted data is normally distributed. View Details Wednesday,
by: Ray Graber Payment Issues-Minimizing the Risk of Duplicate, Fraudulent,and Late Payments.
Identifying, mitigating, and stopping fraud is the key to a successful program. Time is of the essence in identifying and reporting this fraud to recover any losses. You should be armed with the tools necessary to properly audit your current process to make sure the potential for fraud is limited.
by: Betty Lane Corrective Actions - Current expectation of ISO 13485 and FDA auditors
This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. There will be a review of the corrective and preventive action requirements. We will cover how corrective actions should be used throughout your Quality Management System. Definitions of Correction and corrective actions, their differences and importance will be covered. View Details Wednesday,
by: Susanne Manz Managing an FDA Inspection
Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes leading to 483s and even warning letters. This webinar can help you be more professional and polished during an inspection. You will learn how to present information about your quality system in the most competent and professional manner.
10:00 AM PST | 01:00 PM EST Duration:75 Minutes
by: Dr. Ludwig Huber Validation of Analytical Methods and Procedures
by: Louis Angelucci Understanding Proper Application of Risk Assessment
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern. View Details Thursday,
by: John R. Godshalk Lyophilization: What you Need to Know, Validation and Regulatory Approaches
This webinar explores the science and art of lyophilization and discusses how the lyophilization cycle and process is developed and validated, along with the regulatory requirements for lyophilization. View Details Tuesday,
by: John E Lincoln 21st Century Cures Act
The 21st Century Cures Act had wide bipartisan support. A previous version of the bill had stalled in the Senate for more than a year, but this new version had the support of the drug and medical device industries, as well as patient advocates and universities. Consumer watchdog groups and health policy experts have voiced concerns that the Act's funding provisions could hide a loosening of regulations at the FDA, that could put at risk the patients it purports to help. View Details Tuesday,
by: Michael Brodsky Verification or Validation of Methods in Food Microbiology
Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005. Unfortunately, the terms are often incorrectly used interchangeably, resulting in confusion and the application of inappropriate or inadequate analytical evaluations. View Details Tuesday,
by: Heath Suddleson From Project Manager to Project Leader
We manage tasks and activities, and those activities must be performed by people, who must be led. It is not enough to simply be a Project Manager. We must become Project Leaders. Much of this transformation comes from the use of our attitude. View Details Tuesday,
by: Robert J. Russell EU Pharmacovigilance Directive and Regulations
New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) beginning July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents is being written, which will replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU. View Details Wednesday,
by: Greta Hicks Which Fringe Benifits are Taxable vs Non-Taxable
Have your employees, employer or client asked you:
by: Charles H. Paul Implementing an Effective CAPA System
CAPA, no matter how you look at it, is the heart of the quality management system. CAPA can be viewed as and is the merging of change control, continuous improvement, and complaint management. What does the CAPA system do for the organization? CAPA not only indicates the organization's ability to respond to problems that arise but also to proactively anticipate and prevent subsequent problems from arising.
by: Jerry Lanese ICH Q10 - The Pharmaceutical Quality System
Since the turn of the century, the FDA has been telling the industry that it will : regulate using a quality system model, encourage risk-based compliance management and implement science based regulation of product quality. Prior to 2008, The Agency published several guidances and draft guidances that promote a quality system approach. In 2008, the International Conference on Harmonization released ICH Q10, The Pharmaceutical Quality System, which has become the center point for subsequent guidances and regulations published by ICH, FDA, the European Union and pharmaceutical industry focused organizations. View Details Thursday,
by: Jerry Dalfors Lyophilization Technology
Lyophilization cycles consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained. During the freezing phase, the goal is to freeze the mobile water of the product. Significant supercooling may be encountered, so the product temperature may have to be much lower that the actual freezing point of the solution before freezing occurs. View Details Friday,
Pre-Control is easier than SPC! With no control limits to calculate and go/no go colored zones, this control tool can rapidly help to reduce process variation. Participants will observe a modeled session that both develops and runs a Pre-Control chart. View Details Monday,
by: Susanne Manz Quality and Compliance - Building Your Key Capabilities for Future Success
Many medical device companies are surprised when they have a recall, a 483, warning letter or even a consent decree. Yet, all medical device companies follow the same regulatory requirements.So why are some companies more successful than others in terms of quality and compliance? This webinar will explore the seven capabilities every company needs to master in order to succeed in the future. We'll discuss how to evaluate yourself and develop plans to improve your capabilities. You'll learn how to use maturity modeling to develop your Quality and Compliance Strategy.
by: John C. Fetzer Monitoring a quality laboratory to prevent non-compliance
Data quality and compliance to a required level of performance are measured by statistical tools. Usually in compliance there is a very heavy weighing towards only 3-sigma deviations. But statistics gives much more than that. There are other signs that being "out of control" is a building situation. These other statistical patterns can be used to trigger preventive actions without the dire consequence of a non-compliance. View Details Tuesday,
by: Mike Thomas Mastering Excel Formulas and Functions
Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job. View Details Tuesday,
by: Edwin Waldbusser Medical Device Hazard analysis following ISO 14971
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools.
by: Keith Gibbs Computer System Validation: A Project Manager's Perspective
Computer System Validation is an area foreign to most capital projects Project Managers. This webinar will present REAL WORLD lessons learned from the management of dozens of projects in the area of Pharmaceutical Manufacturing Facility construction. A detailed description of a typical requirements will be presented, but more importantly, this webinar will address what that means to a Project Manager and the Project Team. It will give introduction to critical issues and discuss and present case study lessons learned.
by: Thomas E. Colonna Biomedical Software Regulation
The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA). Computer software was in a state of infancy during the 1970's and the role computer software would eventually play in the provision of healthcare was not foreseen. View Details Wednesday,
by: Ray Graber Balancing Customer Satisfaction With Security Issues.
Financial institutions have long been the payments engines for their customers. However, with heightened competition and the advent of new non-bank entries into the marketplace, financial institutions have been playing more defense than offense. It is now time to go from playing 'not to lose' to using the implied trust and the customer experience to reverse the trend, get back lost customers,and retain existing ones. View Details Wednesday,
by: Jose Mora An Advance Course on Lean Documents and Lean Configuration
Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many life science companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process improvements in a timely manner.
by: Thomas Perkins Environmental Compliance in a Food Manufacturing Facility
This training is designed to help process plant management teams be prepared to address major applicable environmental protection programs. Storm water run-off during rain events can affect wetlands close to and very distant from a facility. Management teams must understand the components of storm water permits. We will discuss the permit itself and what makes up a Storm Water Pollution Prevention Plan (SWPPP). Further, the webinar will highlight key distinguishable categories of an air quality permit with regard to noxious emissions. Considerable time detailing the major differences between major and minor generators. Finally, we will give name, description and often overlooked aspects of waste handling. We will discuss major storage and transport requirements of special waste, universal waste, e-Waste, and hazardous materials Often these programs and their administration records are put to the test by third party auditors who are representing regulatory agencies. View Details Thursday,
by: Louis Angelucci Establishment of Quality Systems
Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness. View Details Thursday,
by: Dr. Ludwig Huber Calibration and Qualification in Analytical Laboratories
Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document. View Details Thursday,
by: Miles Hutchinson Mastering the Power of Sensitivity Tools in Financial Modeling
Join us for 90 minutes to learn how to put the powerful sensitivity tools of Microsoft Excel to work in your models. Learn the top 20 best practices of solid model design, development and delivery. Seasoned financial analyst, Miles Hutchinson, will show you how to unlock the power of scroll bars and spinners, goal seek, one and two-input data tables and scenario manager in your models. He will provide you with samples of the tools demonstrated during the webinar along with complete instructions for creating and using each of these tools. View Details Friday,
by: Joy McElroy Best Practices for an Effective Cleaning Validation Procedures
In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. View Details Monday,
by: Jeff Kasoff The FDA Inspection: Preparation, Management, and Follow - up
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.. View Details Tuesday,
by: William Levinson Real World Statistics: What to Do When It's Not a Bell Curve
Statistical textbooks, manuals, and even most software rely on the assumption that processes conform to the normal or bell curve distribution. When the real world process does not cooperate with this assumption, View Details Tuesday,
by: John R. Godshalk Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements are discussed and the reasoning behind them. View Details Tuesday,
by: John N. Zorich Introduction to SPC (Statistical Process Control)
Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation - that is, no two items are identical. What method can we use to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control". View Details Wednesday,
by: Mike Morley SOX: Internal Controls for Accounts Payable
This session will raise awareness of fraud issues in Accounts Payable and examine processes to mitigate the risk associated with Accounts Payable to comply with SOX. It will provide you with the tools you need to establish and maintain strong internal controls that meet Sarbanes-Oxley standards by reducing risk and protecting company assets. View Details Wednesday,
by: Karl J Hemmerich Accelerated Aging Techniques for Medical Device Packaging
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods. View Details Wednesday,
by: Peggy Berry Preparation for GMP Inspections by Regulatory Agencies
Regulatory agencies conduct product-related GMP inspections when assessing an application for marketing approval. This inspection checks if the manufacturer complies with GMP principles and practices from ICH and the local region. Product-related inspections may also be conducted if the agency is informed or suspects a possible GMP breach. View Details Monday,
by: Rachelle D'Souza FDA Regulation, 3D Printing and Medical Devices
This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices. View Details Tuesday,
by: Robert J. Russell Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products. View Details Tuesday,
by: Dan OLeary Acceptance Sampling by Variables
Many companies use attribute sampling plans at incoming, in-process, and final inspection. However, variables sampling plans based on ANSI/ASQ Z1.9 can reduce cost by requiring smaller sample sizes. Z1.9 looks complicated, because it was written before the advent of calculators. A simple statistical calculator eliminates the need for the long form manual calculations of the mean and standard deviation. Z1.9 uses information more effectively than an attribute sampling plan. An inspection operation that measures values and converts them to attributes looses information. As a result, the attribute sample size is larger to compensate. Using the measured values directly can reduce sample size and help lower cost. A calculator or spreadsheet makes the standard easy to implement. View Details Tuesday,
by: Steven S. Kuwahara Auditing Analytical Laboratories for FDA Compliance
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. View Details Tuesday,
by: Heath Suddleson Managing Client Expectations Without Losing Your Shirt or the Next Job
This course will help participants examine issues on the project from multiple viewpoints. While a General Contractor certainly has one perspective on the project, so too do the Owner, Architect/Engineer, Subcontractors, and other Stakeholders. By learning to present issues in the right framework we decrease adversarial behaviors on the project and increase the likelihood that our proposals for additional work will be accepted. View Details Wednesday,
by: Greta Hicks 1099-MISC:Block By Block Discussion
At the completion of this course you will have the tools necessary to evaluate the W9 and prepare a Form 1099-MISC with all the blocks properly completed. This course will cover not only these common mistakes but make suggestions regarding the contents of each Block on the Form 1099-MISC. View Details Wednesday,
If you are constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use. View Details Wednesday,
by: David Nettleton 21 CFR Part 11 - Compliance for Electronic Records and Signatures
by: John E. Grimes Conducting Procurement and Contract Fraud Investigations
Every business that purchases and contracts for goods or services is vulnerable to a wide variety of fraud hazards. Many of the fraud schemes involve vendors and contractors in collusion with employees responsible for making purchases and administrating contracts, as well as with the employee who requests the purchase of goods or services. Other fraud hazards involve solicited and bidding contractors in collusion with each other. Most procurement frauds go undetected due to the off the books nature of the fraud. The ACFE suggests that organizations lose as much as 5% of revenue to fraud. Government Agencies have armies of investigators and auditors whose mission is to prevent and detect procurement and contract fraud. Small, medium, and even large businesses are often not equipped to combat this prevalent vulnerability. The first step is awareness of the hazard. View Details Thursday,
by: Anna Longwell Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability. View Details Thursday,
by: Teri C. Soli Water System Biofilm Control and Microbial Monitoring Myths
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? View Details Thursday,
by: Edwin Waldbusser How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance
09:00 AM PST | 12:00 PM EST Duration:60 Minutes
by: Steven Laurenz Understanding and Implementing a Quality by Design Program
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy. This review will help bridge the gap between understanding the principles and practical application. View Details Monday,
by: John C. Fetzer The role of logbooks and recordkeeping in identifying root causes
The records in a lab - the logbooks for chemicals,reagent and calibration solutions, for sample preparation, for instrument maintenance and calibration, for quality checks - all are time oriented. This gives window of cause-and-effect or coincidence that can give clues. The sum of these, plus the symptoms of the non-compliance can point out the likely root cause. View Details Monday,
by: Jeff Kasoff Best Practices in Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations
This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. Also, discussed will be the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained. View Details Tuesday,
by: Steven Wachs Determining Sample Size: What Sample Size Should I Use?
The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making. View Details Tuesday,
by: Candace Leuck Fundamentals of Fraud
In this webinar, you'll learn about the common types of fraud perpetrated against organizations and how to implement processes, procedures, and controls that mitigate your risk.You'll learn about a number of different fraud schemes, focusing on fraud committed against small businesses. View Details Tuesday,
by: Betty Lane Efficient and Effective FDA and ISO Management Reviews In this presentation will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. Management review should be a key part of keeping your quality management system efficient and effective. It will cover how to get the attention of your senior management as well as practical advice on efficient methods for conducting and documenting management reviews.
by: John E Lincoln DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. View Details Tuesday,
by: Peggy Berry Packaging and Labelling for Commercial and Clinical Products
by: Steven Walfish Using Statistics to Determine Sample Size
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.
by: John N. Zorich Metrology: Statistical Analysis of Measurement Uncertainty
by: Thomas Perkins Food Safety Modernization Act
by: Dr. Ludwig Huber Understanding and Implementing USP 1058 Analytical Instrument Qualification
by: Keith Gibbs Design, Installation, Start-Up and Qualification of Clean Compressed Air Systems for cGMP Manufacturing
Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system. A detailed description of a typical pharmaceutical compressed air system with its individual components will be provided. Engineering schematics will also be included. All component functions will be detailed with recommendations as to which component type is considered optimal. View Details Thursday,
by: Keith Warwick Introduction to environmental engineering and environmental science
This webinar will discuss the financial cost and the human cost of environmental incidents. View Details Tuesday,
by: Jerry Lanese Analytical Method Validation
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle. View Details Tuesday,
by: Heath Suddleson PMBA - Project Management Business Administration
Business Administration is often very generalized and even more often overlooked by project managers. This course is targeted to teach you the strategic and business administration concepts that are specific to project management. View Details Tuesday,
by: Mike Morley IFRS 6 Oil, Gas, Mining and other Extractive Industries
As a finance or accounting professional, you should be familiar with exactly what these IFRS standards for Extractive Industries consist of, and what they mean for companies in the oil, gas and mining industries. This webinar will help you become acquainted with the latest information regarding IFRS for companies in the resource sector. View Details Tuesday,
by: Karl J Hemmerich Validating Radiation Sterilization for Medical Products
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success. View Details Tuesday,
by: William Levinson Theory of Constraints
Manufacturing professionals recognize that inventory ties up cash, provides a hiding place for defects, and also increases cycle time according to Little's Law (inventory = cycle time multiplied by throughput). Alternatively, longer cycle times generate more inventory and also increase the lead time for customer orders. A short cycle time may make the difference between manufacturing to order and manufacturing to meet uncertain sales forecasts.
by: John E. Grimes How To Conduct A Shrink Investigation
This webinar session will explore the importance of controlling losses for a retail business to be successful. A business owner must understand that controlling losses is just as important as controlling sales and costs. Controlling losses is often the area that is overlooked, which leads to many small business retail failures. It is important that business owners Understanding what causes losses, formulate and implement loss prevention policies and procedures, audit and compare practices to established procedures, and learn how to conduct a Shrink Investigation when the source of losses are not identified. View Details Thursday,
by: Charles H. Paul Implementing Cost Effective Regulatory Compliance
This webinar will introduce and overview the concept of containing compliance costs - working smart. The webinar will provide a comprehensive strategy for cost reduction in regulatory affairs and compliance by presenting strategies for complying with FDA regulations in a cost-effective manner. These strategies include:
by: Dr. Ludwig Huber Validation and Control of Excel Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g for data capture, data evaluation and report generation. Regulations such as FDA'sGxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to control, validate and use Excel® requirements can be met. Attendees of this seminar will get all details on how requirements can be met.
by: Thomas E. Colonna FDA Regulation of Combination Products
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. View Details Friday,
by: Joy McElroy FDA Regulations for Analytical Instrument Qualification and Validation Processes
by: Jeff Kasoff Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
by: Peggy Berry Advertising and Promotional material compliance and review process
The information obtained will enable effectiveness and reliability of a review process for all materials.The webinar will address requirements for compliance within the US, "gray areas" that must be evaluated thoroughly, how to conduct a risk assessment,strategies for mitigating risks and making challenging decision. You will hear about the opportunities for input from regulatory agencies at critical stages and on key promotional materials and you will hear strategies for implementing review process and procedures to facilitate high compliance standards. View Details Wednesday,
by: Rachelle D'Souza Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations
This webinar will discuss FDA's current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination product
by: David Nettleton Excel Spreadsheets - Step-By-Step Instructions for Compliance
by: Steven Laurenz Understanding and Implementing a Technology Transfer Process
This training will introduce the concepts associated with implementing a carefully defined technical and business governance programs along with clearly defined R&D to site transfer steps for successful implementation. It will cover the concepts associated with transferring the scientific technology needed to manufacture the product, processes to ensure the receiving manufacturing facility is ready for the product and tools and templates to help capture the knowledge. View Details Monday,
by: Jeff Kasoff How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection. View Details Tuesday,
by: Casper Uldriks FDA Scrutiny of Promotion and Advertising Practices
DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertising methods and messages. The days of looking at text alone for a magazine insert are long gone. You should pay attention to the components of your advertising in mass media, such as volume; images; information prominence and conspicuousness; speed of the message subliminal messaging and "the take away message." This means you need to understand what each component of the advertising attempts to accomplish and then evaluate the integrated message, i.e., the "take away." The difficulty is that this broad horizon of factors gives the FDA abundant opportunities to say that you have misbranded your product. Hence, it is illegal.
by: Steven S. Kuwahara GMP Expectations for Products Used in Early Phase IND Studies
FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1. View Details Tuesday,
by: Peggy Berry Phase I GMPs
by: Thomas Perkins Maintaining instruments and records for pasteurization
This training is designed to help process plant management teams be prepared to answer questions about quality assurance and control across multiple disciplines. The maintenance manager, quality manager, and production manager must see these requirements through a common lens provided by the governing bodies. Often these process controls and their records are put to the test by third party auditors who are representing the global food safety perspective.
by: Betty Lane Medical Device Employee Training -Requirements and Implementation tips
No one disputes the importance of proper training for all employees in a medical device company. Yet defining needs for all employees, either individually or by position description, can be a real challenge. This is especially true for start-up and other small medical device companies, or rapidly growing companies. Specific FDA training requirements will be presented. Techniques for needs assessment and record keeping will focus on in-house training while also covering how experience and outside training can be integrated into this training. Although this presentation will focus on what works for small and medium sized companies, the principles are equally applicable to larger companies. View Details Wednesday,
by: Dan OLeary Regulatory Requirements for Medical Device Calibration Programs
This presentation explains the requirements for control of inspection, measuring, and test equipment. This includes a calibration program that satisfies FDA's Quality System Regulation (QSR), ISO 13485:2003, and ISO 13485:2016. The presentation defines accuracy, precision, and traceability. After explaining the concepts, it moves to an analysis of the requirements from each of the quality management standards. Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. In addition to the specific requirements, the presentation includes examples from FDA Warning Letters, information from FDA's Quality System Inspection Technique (QSIT), and the Medical Device Single Audit Program (MDSAP) Audit Model. View Details Wednesday,
by: Mike Morley Corporate Expense Accounts Review and Audit Best Practices
If you are looking for ways to improve your Corporate Expense Account Oversight and Reporting, you will find best-of-breed practices and suggestions at a basic level. Finance and Operational staff will find this presentation interesting and informative. This webinar will provide you with some of the best practices in corporate expense account review used today. View Details Thursday,
by: Jose Mora Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. View Details Thursday,
by: Dr. Ludwig Huber New FDA/EMA and USP Guidelines for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new guidance from 2015 on validation of analytical methods. And last but not least Europe has released an updated GMP Chapter 6 with clear requirements for comparative testing and acceptance criteria. This seminar will give a good understanding of USP, FDA and EU requirements and provide recommendations and tools for effective implementation.
by: Steven Wachs Modeling and Optimizing Process Behavior using Design of Experiments
This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many common types of experiments and their applications are presented. These include experiments appropriate for screening, optimization, mixtures/formulations, etc. Several important techniques in experimental design (such as replication, blocking, and randomization) are introduced. A Case Study involving optimizing a manufacturing process with multiple responses is presented. View Details Wednesday,
by: John E Lincoln CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. View Details Friday,
by: Jeff Kasoff Equipment Validation, Tracking, Calibration and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, though, to validate equipment already in use. View Details Tuesday,
by: John R. Godshalk Responding to FDA 483's
Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording. This 60 min Webinar will discuss the proper timing and wording to use for the 483 response to put your company in the best position with the FDA. FDA policy and goals regarding the 483 response are discussed. Examples of both good and poor responses are given. Warning Letters and responses are discussed and the implications of both a good and poor response to a possible Warning Letter are given. The standard format of the 483 response is given along with an explanation there of.
by: Peggy Berry SOP Development and Implementation for the Regulated Industry
This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs. View Details Thursday,
by: Candace Leuck Fundamentals of Accounting and Finance for Nonfinancial Professionals
This program covers a general overview of accounting and financial information and how to interpret reports so that you can make the best decisions in your role as a manager in your organization. View Details Thursday,
by: Betty Lane Effective Root Cause Analysis: The key to an effective corrective actions system
In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost effective. We will also cover where else in your quality management system root-cause analysis can be used. Learn how Root cause analysis can be used in process control. View Details Monday,
by: Jeff Kasoff Elements of a CAPA System and Uses of CAPA Data
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Additionally, the application of risk management to a CAPA program will be reviewed, and a specific risk management system explained.
by: Casper Uldriks FDA's New Import Program for 2017
by: Peggy Berry ICH Q11- API Manufacturing
This webinar will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed. View Details Friday,
by: Jeff Kasoff Process Validation: Principles and Protocols
The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit. Domestic and international regulations actually assist in this endeavor, by setting forth the requirements to assure a process is consistent, and that it yields output that is both safe and effective. These requirements are applicable to both automated and manual processes. This webinar explains the regulatory requirements for process validation, and also includes definitions and application of applicable terminology, and hints and recommendation for the more common types of process validation. Also covered will be the validation technique used for processes that are already in place.
by: Jeff Kasoff Personnel Training to Assure FDA and ISO Compliance
To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to verify training effectiveness, and how to document training so that it is readily available for review (by managers, auditors or inspectors).