Source: https://sqa.org/sqa/Education___Career_Development/Quality_College_2016_Apr_Descrips.aspx
Timestamp: 2019-07-22 14:05:09
Document Index: 737074053

Matched Legal Cases: ['§11', '§ 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Quality College 2016 Apr Descrips
April 2016 Quality College Course Descriptions
8:00 AM 3 April 2016 – 5:00 PM 4 April 2016
RQAP re-registration units: 4.00 GLP or non-GCP
FDA/EPA Regulations vs. OECD Principles of GLP
2 — Good Clinical Practice: The Basics (2 Days)
8:00 AM 3 April 2016 - 5:00 PM 4 April 2016
RQAP re-registration units: 4.00 GCP or non-GLP
Be familiar with 21 CFR §11,50, 54, 56, 320, and ICH GCP (book provided)
Learn how to prepare for a GCP audit
Describe 3-5 activities to be done during a GCP audit
History and Principles of GCP
Clinical Study Roles and Responsibilities
Safety Reporting - the Basics
21 CFR § 11 for Beginners
Hosting Audits and Inspections
SOPs and Internal Process Audits
Auditing Vendors for GCP Compliance
FDA Regulation of Clinical Studies
3 — Basic Concepts in Computer Validation (2 Days)
RQAP re-registration units: 4 GCP or GLP
The purpose of this 2-day introductory workshop training session is to provide the QA Professional with an overview of the validation process, regulatory expectations and auditing strategies base on Industry standards and guidance. It also will provide the Course attendees the “how to get it done” by participating in break-out sessions and exercises to enhance their level of understanding the concepts presented. The concepts presented will be based on the industry leading document from the Drug Information Association, Computerized Systems Used in NonClinical Safety Assessment: Current Concepts in Validation and Compliance. This guideline explores the current regulatory environment and new challenges in the development, validation, and use of computerized systems in nonclinical laboratories and describes the best practices to ensure their quality at that time.
The course is designed to provide a thorough understanding of computer system validation by providing a framework on how to execute the System Life Cycle.
The course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process.
The attendee will be familiar with expected content for computer validation deliverables through workshop exercises and examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.
In-depth look at the Validation Deliverables.
4 — CAPA Day One: Problem Definition - Beyond Human Error (1 Day)
8:00 AM - 5:00 PM 3 April 2016
RQAP re-registration units: 2 GCP or GLP
Understand the difference between reactive and proactive.
Understand the advantage of a systematic methodology.
Group practice and report out - scenario
Additional Information - Q&A
5 — GLP Beyond the Basics (1 Day)
RQAP re-registration units: 2 GLP or non-GCP
The GLP Beyond the Basics course is designed to take your application of the GLP regulations to the next level. Learn what types of data you and your management can review to ensure value added auditing and appropriate risk management. Spend the afternoon with us taking a deep dive into the GLP preambles to understand how and where it all began.
Understand types of metrics that can be utilized in a GLP facility
Have a working knowledge of quality risk management and how to apply it to auditing practices
Utilize the preambles to understand the GLP regulations
GLP auditors with three or more years experience.
Quality Risk Management and Metrics
GLP Preambles
6 — CAPA Day Two: Creation and Effectiveness - Beyond Training (Across GxPs) (1 Day)
8:00 AM - 5:00 PM 4 April 2016
Move from Root Cause identified to corrective and preventative action by developing a CAPA that addresses the Root Cause (case studies to be provided for hands-on)
7 — Next Generation QA (1 Day)
The course provides an opportunity for the QA auditor to learn about systems thinking, system dynamics and related areas and how that knowledge may enrich quality management and lead to a deeper understanding of the nature of QA. The intention of the course is to enhance the effectiveness of the QA auditor's own activities and interactions in QA with peers, colleagues and auditees and to develop and refine QA competence beyond the training of GXP regulatory requirements. The course will consist of short presentations/briefings and discussions, case studies, workshops and exercises where participants are invited to contribute.
8 — Basic GCP for Veterinary Studies (1/2 Day)
8:00 AM - 12:00 PM 4 April 2016
The Animal Health Specialty Section (AHSS) of SQA is sponsoring a Basic Veterinary Good Clinical Practice (GCP) training course for all interested animal health professionals. As the title of the course implies, this session is designed as an introductory or refresher course that will cover the basic elements of VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products) GCP. VICH is a trilateral (EU-Japan-USA) program aimed at harmonizing technical requirements for veterinary product registration. The course will be team-taught and will include representation from various companies and possibly one or more regulators.
To review & discuss the roles of the clinical investigator, monitor, and sponsor
To provide an overview of documentation types and requirements
To engage participants with brief scenarios of key points
To discuss the implicit role of quality assurance
Animal Health Professionals (Clinical Investigators, Quality Assurance, Sponsors, Monitors) wanting an overview of the basics of veterinary Good Clinical Practice.
Overview to VICH and GCPs
Quality Assurance’s ‘Implied’ Role
9 — Archiving 101 (1/2 Day)
RQAP re-registration units: 1 GLP or non-GCP
Archiving has gained attention recently as more diverse data types are being generated by scientists and more 483’s are issued by the agency. This course answers the who, what, when, where, why, & how of archiving and associated processes, including auditing an archive.
List the items that need to be archived for a study
Audit an archive for GLP compliance
Outline a plan for establishing a GLP compliant archive
Get a basic understanding of archiving electronic records
This course would be aimed at new GLP auditors or those newly responsible for establishing and/or maintaining a GLP archive.
The Who, What, When, Where, Why, & How of GLP Archiving
The Archive – more than just a place to “store my stuff”
Auditing the Archive
The basics of archiving electronic records
10 — Data Quality/Data Integrity (1/2 Day)
Data Quality and Data Integrity are key components in measuring the reliability, accuracy and confidence in data. This session will provide an overview of the terminology used to define Data Quality and Data Integrity concepts. Evaluation techniques will be presented along with a discussion on the impact of poor Data Quality and Data Integrity.
Describe methods for evaluating Data Quality/Data Integrity
GxP professionals with an interesting in broadening their perspective on Data Quality/Data Integrity concepts.
Concepts to Consider: Stakeholders, Importance of Quality of Source Data, Hard Copy vs. Electronic Data, Using Trends, Impact of using Cloud Computing Infrastructure, COTS/Internally Developed Software, Open Source Tools/Data
How to assess Data Quality/Data Integrity during an audit
Cost of Poor Data Quality/Data Integrity
11 — SQA Leadership (1/2 Day)
1:00 - 5:00 PM 4 April 2016
The SQA Board of Directors has created this course for SQA members. This course is designed to provide SQA members with tools and skills that will enable them to be better leaders in both SQA volunteer leadership positions as well as in other areas of their lives. It will provide a better understanding of SQA leadership responsibilities and an understanding of how SQA is governed. SQA members who are considering running for election or volunteering on Committees or within Specialty Sections will gain a better understanding of the requirements and responsibilities of the positions and the resources and assistance SQA offers to support those positions. It will also provide an opportunity to meet and network with past, current and future SQA leaders and to develop and discuss leadership concepts through fun group exercises. .
Describe how to attract appropriate volunteers and how to get them actively involved
Discuss methods of motivating and rewarding volunteers
Describe how various leadership activities are linked to the SQA strategic plan
Implement effective leadership transition (when leaving a leadership position) so that progress can continue
Demonstrate practical and effective communication techniques
Identify who to ask for help with SQA leadership activities
Use the SQA website to effectively lead and manage committees, specialty sections and/or other ad hoc groups and subcommittees within SQA
Use SQA Headquarters services to minimize workload and maximize results
12 — Archiving 201 (1/2 Day)
1:00 PM - 5:00 PM 4 April 2016
This course is intended to complement the Archiving 101 training by providing in depth review of archiving requirements across multiple regulations, describing what records management means at a corporate level, detailing what to do in case archived records needs to be moved and addressing some of the issues created by acquisitions and divestitures. We will also cover some advanced concepts of archiving electronic records, such as scan and destroy, transferring from paper to electronic....
Describe the regulatory landscape for archiving
Identify the component needed to implement a records management program
Plan and execute a transfer of archived materials
Understand the complexity of archiving electronic records
This course would be aimed at experienced GxP auditors or those responsible for establishing and/or operating a regulated archive or involved in records management.
Regulatory landscape for archiving across GXPs
Records Management - a corporate approach
My archive is moving - What should I do and expect
Advanced topics for Archiving electronic records
13 — GCP Data Stewardship (1/2 Day)
Even established GCP professionals can feel at a disadvantage when facing the regulatory challenges that arise with new digital technologies and electronic data. Data Stewardship is an approach that allows established GCP principles to be applied with confidence in the fast changing world of tablet devices, evolving EDC systems, and eSource. The course particularly highlights managing the challenges posed by the digital environment in dispersing data and responsibility across multiple entities, many of whom are not traditionally regulated. Master the application of GCP-ICH in the operational world of computerized systems used in the conduct of clinical trials--knowing what to do after the validation has been signed. While the course focuses heavily on application in the GCP environment, most elements can also be applicable to GLP and GMP environments.
Identify and apply 5 key established GCP-ICH Good Documentation practices to address issues in the digital data environment.
Analyze the application of GCP-ICH "Predicate Rules" to key digital technologies and "eSource" data.
Create a comprehensive data integrity road map identifying "data steward" entities and their associated areas of stewardship across a Clinical Trial data flow.
Defend Good Documentation Practices for electronic data during health authority inspections.
QA professionals who oversee general GCP-ICH compliance for clinical trials; QA professionals who prepare and support clinical trial teams for health authority inspections; QA professionals in "eCompliance" roles. (e.g., computerized system validation, 21 CFR Part 11, etc.)
Challenges posed to "traditional" GCP QA by the rapidly evolving world of digital devices and eSource in clinical trials.
Beyond 21 CFR Part 11: Using Good Documentation Practices to Cross the IT Boundary--
How the "paper as Gold Standard" metaphor fails us and how we can move beyond it.
Defining and applying "Data Stewardship" in the GCP context.
Identifying & mapping "Data Stewards" and their stewardship domains across a clinical trial.
Defining and using stewardship domains across multiple entities to achieve clarity and consistent compliance.
Demystifying devices, data flows, and data integrity across multiple participating entities (e.g., vendors, IT support, infrastructure support, etc.).
14 — QA Consulting (1/2 Day)
1:00 - 5:00 PM 7 April 2016
A consultant is an individual who possesses special knowledge or skills and provides that expertise to a client for a fee. This interactive course will give examples of expectations of the sponsor (your client) and also CROs that host audits in certain situations, and how to handle troublesome audits for your client. It will also cover ways of organizing the consulting business with regard to legal organization, tax information, physical office choices, marketing, payment structure, insurance, and other necessities and niceties. This course is targeted for those QA professionals who want to learn more about consulting or have desire to pursue consulting as a career.
Formulate ways to handle troublesome audits for your client.
QA professionals who want to learn more about consulting or have desire to pursue consulting as a career.
Handling troublesome audits for your clients
15 — Fraud and Misconduct in PV and GMP (1/2 Day)
This course will discuss the following: No reporting of the serious ADRs for more than 10,000 cases were found at Novartis Japan. Regulatory inspections now conducted by prefectural government did not help for preventing this misconduct. “Self Inspections” which has been required and encouraged by J-GVP law also did not work.; Rambaxy india's GMP quality test was of fraud and FDA inspection noticed eight serious misconducts. Ethical and cultural prejudice is underlying for this fraud.; For preventing the non-compliance, frauds and misconducts, global and powerful audits is the key for the preventive action and importance of quality assurance action is strongly proposed.
Understand Novartis Japan's PV incompliance
Understand Rambaxy India's GMP Fraud
Recognize what caused for these examples of misconduct and fraud
Understand the importance of (global) quality assurance
Understand how the management can prevent fraud and misconduct within their company
PV auditors and GMP auditors with three or more years experience; Corporate top managers who want to prevent company fraud and misconduct
Incidents and Information
Company's Immediate Action
Preventive Action and Solutions
What Should QA Do?
16 — History of the FDA GLPs (1/2 Day)
17 — E2E Electronic Laboratory (1/2 Day)
Have you ever wondered what it takes to make your laboratory fully electronic? How can you develop and execute a compliant system for data capture and reporting that can be shared with external auditors and health authorities? This course will address all the steps necessary to design, test, and execute a fully electronic laboratory.
List the criteria needed for effective, compliant electronic data capture.
Identify archival and retrieval strategies and storage.
Understand the single most important criteria for automated data transfer between systems.
Identify the 5 most important design elements of an E2E electronic laboratory.
Target audience will include all QA professionals with a role in executing or auditing data within the Bioanalytical arena including computerized system validation, instrument validation (IQ, OQ, PQ), data capture, data reporting, and inspection by health authorities.
Intro to Part 11 compliance and data capture requirements of GLP and OECD
System Rollout and Training
System Use for external Groups
18 — GCP Beyond the Basics (1 Day)
8:00 AM - 5:00 PM 8 April 2016
RQAP re-registration units: 2 GCP or non-GLP
This interactive session will provide experienced GCP QA professionals with additional tools to incorporate into how they perform audits, training and GCP support within their roles. This session has been designed to provide best practices and audience participation activities that highlight the experience of the presenters and the attendees. In addition to these topics, this session will also provide the regulatory perspective as it relates to the current status of GCPs as experienced in the global community.
Describe how GCP QA interacts with a Quality System Approach
Incorporate presented audit and training techniques into their roles
Incorporate current Regulations that impact GCP into their roles
Discuss how to set-up a GCP QA Program
GCP Professionals with two or more years of experience.
Applying a Quality System Approach to GCPs
Setting up a GCP QA Program
19 — No Such Thing as GxP - A Quality System Management Approach to Navigate a Complex Regulatory Environment Compliance (1 Day)
This course is designed to broaden/promote a better understanding of the various title 21 regulations among QA professionals in order to expand knowledge and improve communication among SQA members, sponsors, regulatory agencies, and CROs. Course content addresses regulations from a Quality System perspective. A panel of expert speakers utilize basic elements of Quality Systems to describe GLP, GCP (human and veterinary), and GMP regulations. Knowledge learned is applied to enhance understanding of complex areas such as GLP efficacy studies (for Animal Rule), laboratory assays conducted under Good Clinical Laboratory Practices, 21 CFR Part 11, and documentation standards for product development studies. Additional course topics include an overview of the regulatory pathway, the role of Regulatory Affairs, and the applicability of corrective and preventive actions (CAPA). Attendees will test their knowledge by participating in case study discussions. A Question and Answer Panel session is included to promote open discussions with attendees.
Compare and contrast title 21 regulations using Quality System elements
Recognize differences in regulation terminology
Apply Quality System processes to reduce compliance risk
This course is suitable for all QA professionals. Novice auditors will gain knowledge of the "big picture" of the entire regulated process while also learning important terminology. Seasoned QA professionals who specialize in one area of title 21 regulations will gain an understanding and appreciation of differences and commonalities that are shared with colleagues working in other specialty areas.
Overview of the Regulatory Pathway
GLP as a Quality System
Applying GLP as a Quality System to Product Development Studies
Human GCP as a Quality System
Veterinary GCP as a Quality System
GMP as a Quality System
Combining Quality Systems for Animal Efficacy Studies (Animal Rule studies)
Applying Quality Systems for Good Clinical Laboratory Practices
The Role of Part 11 in Quality Systems
CAPA Systems & Root Cause Analysis Across title 21 Regulations
20 — Auditing Software and Data Providers with a Focus on Cloud Services (1 Day)
By the end of this training, you will have the essential and practical knowledge and tools for auditing software and data providers. This session will focus on computerized systems that not only reside locally, but also in the cloud. The session teaches you how to develop audit plans, and focus on the goals of the audit to guide you and your team in the execution of the audit strategy. Additionally, with the advent and increased use of hosted services (e.g., Cloud Computing), this training will explain the overuse of the term “Cloud Computing” and the similarities and differences in auditing Contract Data Center/Host Service sites.
Establish Vendor Audit strategy for Computing Technology Providers.
Develop the purpose and goals of a Software or Data Supplier Audit.
Organize an Audit team for a Software or Data Provider Audit.
Assess business and technology capability for a Supplier.
Evaluate business and technology risks to your organization.
Organize and execute an effective Audit for a computerized system, software or data or cloud provider.
Examine suggested approaches for conducting and reporting vendor audits.
Audit Report & Follow-up
21 — Study Director Training (1 Day)
RQAP re-registration units: 2 non-GCP or non-GLP
This course provides a thorough overview of the regulatory requirements for study oversight and direction and the roles and responsibilities of GLP Study Directors and Principal Investigators.
Provide background on why GLPs exist
Be familiar with regulations/standards
Understand GLP requirements
Have respect for importance of GLP principles
Provide sources of information/resources
Have knowledge applicable to job function
Individuals who are new to, or in training for, the role of Study Director or Principal Investigator or those who are seeking a comprehensive refresher of what it means to be the single point of GLP study control and study/study phase direction.
BRIEF HISTORY OF GLP REGULATIONS
GLP REGS & STANDARDS (SIMILARITIES AND DIFFERENCES)
FDA/EPA/OCED
STUDY DIRECTOR AND PRINCIPAL INVESTIGATOR ROLES & GLP RESPONSIBILITIES
GLP Personnel responsibilities
Study Director/PI
Single Point of Control/Delegation
TFM/TSM responsibilities delegated to SD
SD/PI and QA interaction
Study preparation, SD/PI involvement, Study close out
Sponsors, SD, PI, QA
Test Facility/Test Sites
SD oversight and responsibilities
TYPES OF STUDIES, FACILITIES AND ANIMAL/TEST SYSTEM CARE
Study Director Responsibilities
GLP Equipment (includes computerized systems)
FDA/EPA/OECD terminology and definitions
Bulk and Mixtures
Characterization & Stability
Dose Formulation/Dose Analysis
STUDY PROTOCOL/ PLAN, CONDUCT AND STUDY REPORTS
GLPs requirements
Study Phase Reports (PI/Contributing scientist reports)
Study results interpretation
Archival and Record Retention
Manually-recorded and computer-generated records
Agency Audits/483s
Risk to public health & safety