FDA Regulations for Pharmaceutical Good Manufacturing Practice (GMP)

OVERVIEW

The US Food and Drug Administration (FDA) has detailed regulations for pharmaceutical Good Manufacturing Practice (GMP). These regulations describe in general terms the minimum requirements for preparation of over-the-counter (OTC) and prescription (Rx) drug products. These regulations are divided into 11 major subparts, each of which has various subparts. All employees of pharmaceutical manufacturing firms are required to be trained in and to know the GMP regulations that are relevant to their job functions.
WHY SHOULD YOU ATTEND

• Regulatory affairs managers, directors and associates
• Compliance specialists
• Quality professionals
• Internal and External trainers

LEARNING OBJECTIVES

• Understand General Provisions
• Review Organizations and Personnel
• Requirements for Buildings and Facilities
• Requirements for Equipment
• Understand Control of Components
• Understand Control of Packaging Components
• Requirements for Production and Process Controls
• Requirements for Packaging and Labeling Controls
• Review Holding and Distribution
• Understand Data Integrity Requirements
• Review Laboratory Control Requirements
• Review Records and Reports
• Understand Returned and Salvaged Drug Products

AREAS COVERED

• General Provisions
• Organizations and Personnel
• Buildings and Facilities
• Equipment
• Control of Components
• Control of Packaging Components
• Production and Process Controls
• Packaging and Labeling Controls
• Holding and Distribution
• Data Integrity Requirements
• Laboratory Control Requirements
• Records and Reports
• Returned and Salvaged Drug Products
• FDA Inspections
• FDA Warning Letters and 483s re GMPs

WHO WILL BENEFIT?

• GMP Trainers
• Quality Supervisors and Managers

SPEAKER

Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.