Discussion Regarding the Substitution of a New Inactive Ingredient in an Approved Parenteral Drug Product

Duration: 60 Minutes
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The worldwide market of excipient manufacturer requires that the food, drug and cosmetic industries play close attention to new and novel ingredients used in the manufacture of products. The sources of various inactive ingredients, natural or synthetic must meet safety requirements (FDA and ICH Guidance's on the safety evaluation of pharmaceutical excipients and S7A). The main focus of the discussion will be centered on the aspect of excipients affecting drug applications. However, it should be noted that many of the excipients deemed ok for human consumption by food or cosmetics regulations must never the less be viewed under further scrutiny by regulatory bodies for medical/drug application and usage.
FDA Inactive Ingredients Guide
Instructor: Lamont M. Fulton
Product ID: 505414
Objectives of the Presentation
  • Can a new excipient that has been previously added to an approved injectable reduce QBD developmental time?
  • Can the use of a different excipient effect particulate formation?
  • Define analytical methods used by excipient manufacturers
  • Listing critical physico-chemical properties on inactive ingredient certificates of analysis
  • New and novel excipients and special safety concerns
  • Traditional excipients and new manufacturing processes
Why Should you Attend
Attend this webinar to gain an appreciation of the regulatory CMC and compliance issues effecting inactive ingredients/excipients in the international Pharmaceutical marketplace and to develop a universal criterion for the acceptance and use of inactive ingredients manufactured from various firms.

Areas Covered
  • Function of excipients in the formulation
  • FDA inactive ingredients guide
  • Human use and toxicology studies
  • Inactive ingredient interactions (physical and chemical compatibility)
  • Excipient safety concerns (allergies and other adverse reactions)
  • Stability of inactive ingredients and degradation products
  • Type IV DMF
  • Inactive/excipient monographs listing in USP/NF, EP, JP, and others Pharmacopeia
  • IPEC and FDA concerns
Who will Benefit
  • Formulation scientist
  • Product development
  • Analytical Chemist
  • Materials Management
  • Regulatory Affairs and compliance
  • Quality assurance and Control
  • Senior quality managers
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Development professionals
  • Senior development managers
  • Risk Management
  • Quality assurance/control
  • Project engineers and managers, commissioning, validation, engineering and service providers
  • Manufacturing operations and facilities professionals
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Instructor Profile:
Mr. Lamont M. Fulton is President of Regulatory Direction LLc and has overForty years of Pharmaceutical experience (26 inregulatoryaffairs CMC).Mr. Fulton 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 anAnalyst in the office of regulatory affairs and international office of policy, dealing with FDA/ICH regulations and guidance for global initiatives.

Mr. Fulton's past experience in government and industry, including his current role as senior consultant, has allowed him the opportunity to develop relationship with various CMC partners(Pfizer, Johnson and Johnson, Bristol Myers Squibb, etc.). It has also afforded his consultancy the chance to assist and manage other multidisciplinary teamsachieve approval fordozens ofNDA's, ANDA's to the FDA, as well as provide help with several successful international drug applicationsto the EMEA, MHLW and ROW.

The blended years of both pharmaceutical quality and regulatory affairs has provided Mr.Fulton with a perspective to determine appropriate filing strategy and provide regulatory impact of changes in postâ??marketing products.

Mr. Fulton has BA degree in Chemistry from Cheyney University of Pennsylvania; where he studied under Dr.Taylor on the nature of terpenes and its various derivative. Certificate of Pharmaceutical training from University of Maryland school of Pharmacy / FDA program.

Mr. Fulton's affiliations included; GPhA (Generic Pharmaceutical Association), ACS American chemical society) RAP (Regulatory Affairs Professional society), PDA (Parenteral Drug Association); Sigma Xi.
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