Engaged. Knowledge. Application
Webinar Recording-Basic Principles of Drug GMP: Meeting FDA Requirements
Thursday, October 22, 2009
10:00 a.m.-11:00 a.m., Eastern Standard Time (United States)
Instructor: John Stromp, former Manager Documentation, Regulatory and Compliance, GlaxoSmithKline
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Webinar Content
Origins of GMP
➢Food, Drug and Cosmetic Act (FD&C) Act
➢Code of Federal Regulations Title 21 (CFR 21)
➢CFR 21 Parts 210 and 211
Critical Areas of Manufacturing Covered by GMP
Subpart B-Personnel
➢General requirements
➢Quality unit
➢Training
➢Common sense practices
Subpart C-Buildings and Facilities
➢Design and construction
➢Environmental controls
➢Water systems
➢Sanitation and maintenance
Subpart D-Equipment
➢Design and construction
➢Maintenance and cleaning
➢Maintenance and cleaning procedures
➢Calibration
➢Computerized systems
Subpart E-Components & Drug Product Containers and Closures
➢Raw materials & packaging components
➢Receipt and quarantine
➢Sampling and testing
➢Storage
Subpart F-Production and Process Controls
➢Validation
➢Change control
➢In-process testing
➢Reprocessing
➢Contamination control
➢Packaging and labeling
➢Written procedures
Subpart G-Packaging and Labeling
➢Materials examination and usage
➢Labeling issuance
➢Packaging and labeling operations
➢Tamper-resistant packaging
➢Drug product inspection
➢Expiration dating
Subpart H-Holding and Distribution
➢Warehousing procedures
➢Distribution procedures
Subpart I-Laboratory Controls
➢Testing of materials
➢Sampling
➢Test methods
➢Stability program
➢Reserve samples
Subpart J-Documentation and Reports
➢Batch production records
➢Test records
➢Equipment records
➢Deviations and complaints
➢Change control documentation
QUESTIONS AND ANSWERS
There will be a 15-minute question and answer period for attendees to submit questions. If we are unable to answer your question due to time constraints, our instructor John Stromp will provide an email response after the webinar concludes.
WHAT YOU WILL LEARN ATTENDING THIS WEBINAR
This webinar intends to provide learners with a fundamental understanding of GMP regulations’ purpose, content, requirements and applications.
➢How Part 210 relates to Part 211
➢The relationship of the FD&C Act to GMP regulations
➢The requirements of each Subpart of Part 211
➢Identify practices that comply with regulations in Part 211
➢The interrelationship of each individual GMP regulation
WHO SHOULD ATTEND THIS WEBINAR
This subject matter content is designed for new hires or professionals in the pharmaceutical industry who desire to have a greater understanding of Drug GMP. Quality assurance, packaging, operations, manufacturing, training, regulatory affairs, validation and transportation and logistics personnel would benefit from attending.
ABOUT YOUR INSTRUCTOR
John Stromp currently serves as a Subject Matter Expert and Instructional Designer for enKap. In his career, he has worked at Bausch & Lomb, Duramed Pharmaceuticals, Glaxo SmithKline and American Red Cross in packaging development, quality assurance and regulatory affairs.
As former Manager, Documentation, Regulatory and Compliance at GlaxoSmithKline, his DEA compliance responsibilities included serving as the lead individual for DEA inspections, monitoring security systems for the holding of controlled substances, filing required DEA reports, maintaining DEA registration certificates for facilities, reviewing distribution records for controlled substances, reviewing receipt, inventory and product return records for controlled substances, reviewing reconciliation records for controlled substances, witnessing and verifying destruction of controlled substances, serving as the point of contact for the DEA to answer their inquiries, and reviewing and approving labeling for controlled drug products.
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