FDA Regulations for Pharmaceutical Good Manufacturing Practice (GMP)

FDA's Good Manufacturing Practice regulations set the minimum requirements for making over-the-counter and prescription drug products. Everyone at a pharmaceutical manufacturer must be trained in the parts that apply to their job. This 90-minute FDA pharmaceutical GMP regulations training walks through them.

The regulations are divided into 11 major subparts. You'll review general provisions, organization and personnel, buildings and facilities, equipment, control of components and packaging components, production and process controls, and packaging and labeling controls.

The session also covers holding and distribution, laboratory controls, records and reports, returned and salvaged drug products, data integrity requirements, FDA inspections and GMP-related warning letters and Form 483 observations.

• Explain the general provisions and organization and personnel requirements
• Apply requirements for buildings, facilities and equipment
• Control components and packaging components
• Meet production, process, packaging and labeling control requirements
• Apply holding, distribution and laboratory control requirements
• Maintain compliant records, reports and data integrity
• Handle returned and salvaged drug products

• General provisions
• Organization 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 related to GMPs

GMP training is a requirement, not an option, and gaps in knowledge show up as inspection findings. This session gives you a structured review of the regulations you need to know and teach.

It suits regulatory affairs managers, directors and associates, compliance specialists, quality professionals, quality supervisors and managers, and internal, external and GMP trainers.

• GMP Trainers
• Quality Supervisors and Managers

Dr. Loren Gelber is currently an independent consultant, based in Charlotte, NC.She previously was employed by Akesis, Bestsweet, RRI, Andrx, Royce, Universal Research, Danbury Pharmacal, Barr and the US FDA. She has been in Regulatory Compliance, Regulatory Affairs, Clinical Research and Quality Control Laboratories.

Dr. Gelber has a Ph.D. in Medicinal Chemistry from Northeastern University, a Masters in Chemistry from Brooklyn Polytechnic and a Bachelors in Biology from Brandeis University.