AAPS Workshop Addresses Pre-Approval Inspections by Regulatory
Agencies
ARLINGTON, Va. — The American Association
of Pharmaceutical Scientists (AAPS) will present the AAPS Workshop on Practical
Approaches to Current Pre-Approval Inspection Initiatives: Good Manufacturing
Practices (GMP) and Good Laboratory Practices (GLP) on Jan. 8-10, 2001 in Arlington,
Va.
The workshop will provide scientists with an in-depth review
of Pre-Approval Inspections conducted by FDA and other regulatory agencies and
practical approaches from the industrial perspective.
“This workshop is designed to help people in the industry
who have the responsibility of coordinating inspections by governing agencies.
The workshop also addresses what to expect from European and Canadian agencies,”
said Chris Bapatla, Ph.D., the workshop’s planning committee chairman.
Workshop attendees will:
- Gain an understanding of what to expect during an audit;
- Find out the most common observations made during inspections;
- Learn how to prepare for successful Pre-Approval Inspection outcomes; and
- Gain insight into agency and industrial experiences with pre-approval inspections.
Session topics include:
- The FDA inspection process;
- New drug application (NDA) pre-approval inspection program;
- NDA and abbreviated new drug application (ANDA) review process;
- Pre-approval inspection program with the active pharmaceutical ingredient
manufacturer, generic, and excipient industry perspectives;
- Most common observations made during GMP compliance audits of new drug applications
and abbreviated new drug application dosage form manufacturers;
- GMP inspections with industry and FDA updates; and
- Unique requirements for biological active pharmaceutical ingredients and
pre-approval inspections experiences.
For more information on this workshop, including a complete preliminary program,
registration fees, and accommodations, visit AAPS Pharmaceutica at www.aapspharmaceutica.com/pai.
About AAPS
AAPS is a professional, scientific society of more than 11,000 members employed
in academia, industry, government and other research institutes worldwide. Founded
in 1986, AAPS aims to advance science through the open exchange of scientific
knowledge, serve as an information resource, and contribute to human health
through pharmaceutical research and development. For more information about
AAPS, visit AAPS Pharmaceutica at www.aapspharmaceutica.com.
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