Source: http://www.docstoc.com/documents/conferences/healthcare-and-medicine/16
Timestamp: 2015-01-29 08:18:09
Document Index: 11696025

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art11', 'art 11', 'art\n820']

Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel
The manufacturer must validate these processes with a "high
degree of assurance". The presentation explores the statistical
underpinnings of these two phrases. To "fully verify the output"
relates to the use of statistical sampling plans, while "high degree
of precision" relates to process capability. The presentation
illustrates the statistical concepts.
risk management, Risk Assessment, management process, Risk Identification, risk management plan, Risk Manager, risk management strategies, quality guidelines, Pharmaceutical Technology Europe, risk management
Constienta /Awareness de Anthony de Mello traducere de Dan Mirahorian
Constienta de Anthony de Mello, S.J.
Awareness by Anthony de Mello, S.J.
Trezirea oamenilor la realitatea maretiei lor
Waking people up to the reality of their greatness
intr-o nouă traducere in limba română de:
in a new translation in Romanian language by
Constienta, Awareness, Anthony, Mello, traducere, Mirahorian
BRC Risk Analysis - Webinar by GlobalCompliancePanel
Risk Assessment is a fundamental and intuitive activity that is
not new to manufacturing professionals. Bringing
consciousness and tangibility to this process is the challenge
often faced. A practical guide documenting the process will be
the topic of this training. This presentation will take you step
by step through the creation of each type of risk assessment
required by the BRC. Process and product driven risk matrices
will be presented. Sources of supporting documentation
demonstrating the rationale utilized to arrive at conclusions
will be provided. Quantification of risks and the progression to
meaningful programs with defined goals.
Top Selling Webinars on Water Systems - Pack of 8 Courses by GlobalCompliancePanel
GlobalCompliancePanel brings you a special Water Sysytem training primer. A package of 4 of our best selling Water Sysytem webinars- available at a 50% discount.This pack of 4 courses contains some of our best selling Medical Device webinars which together cover the essential compliance challenges faced by Water Sysytem companies today.
Top Selling Medical Devices Webinars - Pack of 10 Courses by GlobalCOmpliancePanel
GlobalCompliancePanel brings you a special Medical Devices training primer. A package of 4 of our best selling Medical Devices webinars- available at a 50% discount.This pack of 4 courses contains some of our best selling Medical Device webinars which together cover the essential compliance challenges faced by Medical Device companies today.
Top Selling Food Webinars - Pack of 4 Courses
GlobalCompliancePanel brings you a special Food Industry training primer. A package of 4 of our best selling Food webinars- available at a 50% discount.This pack of 4 courses contains some of our best selling FOOD webinars which together cover the essential compliance challenges faced by Food Industry companies today.
The ICF Process: Tips on Achieving Optimal compliance and Comprehension - Webinar by GlobalCompliancePanel
This session will discuss the issues and consequences
surrounding an inadequate informed consent process and
provide tips on how to create an informed consent process
that achieves optimal site compliance and subject
Internal Audit, risk management, Risk Assessment, management process, Risk Identification, risk management plan, Risk Manager, risk management strategies, quality guidelines, Pharmaceutical Technology Europe
Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner - Webinar by GlobalCompliancePanel
Supplier qualification and assessment is required in both the
QSR regulations and ISO standards.
Many companies spend a great deal of time and money in
pursuit of compliance with this. Many companies can spend
MUCH LESS time and money, and still be in control of their
suppliers and in compliance with the regulations. This
presentation will review the QSR and ISO requirements for
supplier evaluation and assessment, and provide cost
efficient, equally compliant options to many of the most
common practices.
ISO requirements, medical conferences, risk management, Risk Assessment, management process, Risk Identification, risk management plan, Risk Manager, risk management strategies, quality guidelines
Regulatory Complaint Handling, MDR's & Recalls - Webinar by GlobalCompliancePanel
Medical device firms need to be aware of the benefits of
compliance as well as the dangers of inadequate complaint
handling. This Webinar will explain the regulatory process and
in understandable terms. Many medical device firms face
regulatory issues as a result of inadequate complaint
handling. FDA has explicit complaint handling requirements
and poor complaint & reporting procedures often result in
costly recalls and warning letters. FDA warning letters and
recalls are posted on FDA's website and published in trade
magazines, newspapers available to firm's competitors, and
has even driven the firm's stocks down. This presentation will
review the regulations and point out some of the pitfalls in
complaint handling and reporting.
Project Management for FDA-Regulated Companies - Webinar by GlobalCompliancePanel
This webinar will provide valuable guidance to regulated
companies in development and implementation of Project
Management Planning and Techniques for new product
development, regulatory compliance audit responses, proof of
"progress against plan", and other activities requiring a
planned documented rationale. Three of the most common
tools will be discussed. One very simple approach using
common Excel- or Word-type PC applications programs that
can be used immediately. Regular use of a few simple but
powerful tools will virtually eliminate "fire fighting" in a new
Regulated Companies, Quality Digest, Regulated Companies, FDA QSR, ISO 13485, Risk Assessment, GMP Requirements, FDA Inspection, risk management, Risk Assessment
Medical Device Classification - Webinar by GlobalCompliancePanel
The webinar explains the two dimensional system the FDA
employs, classifying each device by risk class and associated
panel. This leads to specific regulations for each device type.
FDA QSR, How to, 21 CFR Part 11, ISO 13485, Business and Economics, FDA Inspection, GMP Requirements, Risk Assessment, risk management, Risk Assessment
Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971:2009 Requirements - Webinar by GlobalCompliancePanel
FDA Warning Letters and recent high-profile recalls indicate
major cGMP deficiencies in many companies. One major failing
is lack of sufficient or targeted risk-based V&V planning.
Starting with a Master Validation Plan, evaluating its elements
against ISO 14971 hazard analysis / risk management, allows
development of meaningful product validations. The roles of
different V&V protocols. How to employ equipment / process
DQs, IQs, OQs, and PQs, against a background of limited
company resources (personnel, budget, time). A matrix
simplifies "as-product", "in-product", process, and equipment,
et al, software V&VT, assuring key FDA requirements are not
overlooked. The QMS and 21 CFR Part 11 must be considered.
Verification and Validation, ISO 14971, risk management, Risk Assessment, management process, Risk Identification, risk management plan, Risk Manager, risk management strategies, quality guidelines
Food Traceability Program and EfficacyVerification - Webinar by GlobalCompliancePanel
Product traceability requirements for meeting Food Safety and
Quality standards as required by BRC fundamental clause 5.0,
SQF item 4.5, 9 CFR will be covered. The purpose of
traceability and its value to the brand will be explored. The
resources necessary to achieve an effective result will be
presented. A customer perspective on the importance of
product traceability from a customer perspective will be
shared with the attendees to bring justification for team
support of these time consuming exercises. Specific examples
of the costs of an expanded vs a targeted recovery. Daily
process documentation is key to achieving effective product
recovery. A critical component of identity preservation and the
result of lack of identity preservation.
Risk Assessment, Regulated Companies, Quality standards, Quality Assurance, FDA audits, risk management, Risk Assessment, management process, Risk Identification, risk management plan
FDA's Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel
FDA recently released a final rule regarding the parameters in
which a device manufacturer can modify label changes to a
product. Specifically, manufacturers can add or strengthen the
contraindications, warnings, precautions or adverse reactions
sections of labeling via a PMA supplement without prior FDA
approval only when such modifications are based on newly
acquired information and evidence of a causal association
between the product and a safety signal is present. The rule
also provides clarification as to what the Agency considers to
be new information to be incorporated into a label change.
FDA QSR, Medical Device, 21 CFR Part 11, Risk Assessment, ISO 13485, GMP Requirements, medical devices, risk management, Risk Assessment, management process
FDA's New Enforcement of 21 CFR Part 11 - Webinar by GlobalCompliancePanel
FDA's new Part 11 regulation takes quite some time, but
inspectors go out and inspect computer systems and erecords
for compliance with GMPs and most recent Part11
interpretations. Just from 2007 to 2010, there have been
about 30 Warning Letters related to Part 11 compliance,
some with disastrous consequences for inspected companies.
It seems that 'enforcement discretion' as stated in the 2003
guidance is not applied any more. FDA's computer expert John
Murray recommended at a conference to follow 21 CFR Part
820 also for drug companies but industry needs more
guidance and practical recommendations on how to respond
to FDA's new enforcement practice.
ISO 13485, FDA QSR, GMP Requirements, FDA Inspection, Medical Device, risk management, Risk Assessment, management process, Risk Identification, risk management plan