Based on knowledge of the active and inactive ingredient's function and role in the finished dosage form, Compendia methods and specifications are clearly accepted by third parties and regulatory agencies.
Why should you Attend:
The FDA has Approved hundreds of inactive ingredients for thousands of products with various dosage forms (routes of administration). The quantities and quality of each inactive ingredient is critical to the function and design of the final product formulation.
Areas Covered in the Session:
Description of the API and excipient manufacturing process and facility
The supplier's commitment to conforming to appropriate excipient GMP requirements
Characterization of the composition of the excipient.
Acceptability of Standards from Alternative Compendia (BP/EP/JP)
Who Will Benefit:
Product Development/Formulator / R & D Chemist
Analytical Chemist/QC Lab
Mr. Lamont Michael Fulton is President of Regulatory Direction LLc and has over Forty years of Pharmaceutical experience (26 in regulatory affairs CMC).He has had roles as both Manager and Director of Chemistry Manufacturing and Controls (CMC) Regulatory and labeling at both Branded (Merck, SmithKline, Wyeth) and Generic drugs firm (Mylan).
Event Fee: One Dial-in One Attendee Price: US$150.00
Compliance4All DBA NetZealous,