Discussion on Raw Material Methods and Specifications
ENDED
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Compliance4All
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USD 150.00
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Overview: 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: Quality Assurance/Control Product Development/Formulator/R&D Chemist Analytical Chemist/QC Lab Regulatory Affairs Material Management Speaker Profile: 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 Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: [email protected]
Outline
Speaker/s
Speaker Profile
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). Prior to working as the leader to regulatory affairs departments, Mr. Fulton worked at the FDA as a Chemist reviewer in the center for drugs. While at the FDA, He also
worked as an Analyst in the office of regulatory affairs and international office of policy, dealing with FDA/ICH regulations and guidance for global initiatives.
Special Offer
One Dial-in One Attendee
Price: $150.00
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Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
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