The Good Laboratory Practice regulations describe the minimal standards
for conducting nonclinical laboratory studies that support or are
intended to support applications for research or marketing permits for
products regulated by FDA or EPA such as animal food additives, human
and animal drugs, medical devices for human use, biological products,
electronic products, or pesticide products. The Good Clinical Practices
regulations pertain to studies utilizing human subjects or clinical
studies. While the GLPs do not specificall pertain to basic exploratory
studies carried out to determine whether a test article has any
potential utility or, for FDA studies only, to determine physical or
chemical characteristics of a test articl, adherence to their principles
will further ensure the accuracy of any results achieved. And the GMPs
pertain to the manufacture of product to be used in trials and then in
release to the field / public.
Why you should attend
This
webinar will define what are the US FDA's expectation for proper
laboratory / clinical / manufacturing practices, systems, equipment
usage, and documentation / record-keeping.. It will evaluate the
requirements for how basic Quality Management System (QMS) expectations
/ requirements are addressed in these environment. The webinar with
evaluate pharma GMPs and 21 CFR 58 and associated regulations to see how
the GLP's can be implemented in the real world to achieve FDA
requirements and ensure the accuracy and repeatibility / reproducibility
of lab results. There will be a detailed analysis of the applicalbe
regulations for industry. Subject areas considered are:
- Lab / Clinical / Manufacturing Control / Systems
- Facilities and Equipment
- Documentation and Records
- Materials Management
- Personnel / Assignments
- Validation
- The Lab GLPs, IRBs/GCPs, and company CGMPs
Who Will Benefit
- Senior management in Devices, Pharma, Combination Products
- QA / RA
- Medical Products Development and Testing testing Teams
- R&D
- Engineering
- Production
- Operations
- Marketing
- Consultants; others tasked with Medical Product Development, Manufacturing, Logistics and V&V Responsibilities
John E. Lincoln is a medical
device and regulatory affairs consultant. He has helped companies to
implement or modify their GMP systems and procedures, product risk
management, U.S. FDA responses. In addition, he has successfully
designed, written and run all types of process, equipment and software
qualifications/validations, which have passed FDA audit or submission
scrutiny, and described in peer-reviewed technical articles, and
workshops, world wide. John has also managed pilot production,
regulatory affairs, product development/design control, 510(k)
submissions, risk management per ISO 14971, and projects; with over 28
years of experience in the FDA-regulated medical products industry -
working with start-ups to Fortune 100 companies, including Abbott
Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
The full agenda is not yet available for this event.
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Time: 08:00 AM PDT | 11:00 AM EDT- Key Regulatory Espectations
- GLP/ GCP / GMP specifics
- Systems, Personell, Facilities
- Required documentation / records
- Control of equipment / test material / samples
- Laboratory Controls in the CGMPs
- Clinical documents
- CGMP requirements
- Validations
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
