This GMP Compliance training course is designed to give participants a solid understanding of the regulatory expectations surrounding Good Manufacturing Practices (GMPs) for drug, biologics, and combination product manufacturers. Attendees will explore FDA and international agency requirements, quality system regulations, risk-based approaches to compliance, and effective methods for implementing and sustaining GMP programs across all stages of the product life cycle.
This program uses real-world examples, recent inspection findings, and interactive exercises to reinforce how GMP compliance can be maintained and improved across manufacturing, quality control, and quality assurance operations. By the end of the course, participants will be equipped to evaluate their own systems for GMP readiness and to lead initiatives that enhance compliance and inspection outcomes.
This program uses real-world examples, recent inspection findings, and interactive exercises to reinforce how GMP compliance can be maintained and improved across manufacturing, quality control, and quality assurance operations. By the end of the course, participants will be equipped to evaluate their own systems for GMP readiness and to lead initiatives that enhance compliance and inspection outcomes.
Why You Should Attend
This training provides the essential tools and regulatory context needed to understand and meet GMP compliance expectations. Whether you’re new to the field or looking for a refresher, this course offers actionable insights and a solid foundation for aligning with FDA and global GMP regulations.- Understand the structure, requirements, and intent behind current GMP regulations (FDA, EU, WHO)
- Learn how GMPs apply across the product life cycle
- Identify key inspection focus areas and common GMP deficiencies
- Gain strategies for implementing risk-based thinking in GMP compliance
- Strengthen your company’s inspection readiness and internal audit programs
Course Content
DAY 1Session 1
- Seminar objectives review, expectations and scope
- Interview attendees regarding their specific responsibilities and needs
- Agreement on focus
- Food and drug oversight
- Pivotal events that shaped laws in US and scope of FDA actions
- Examples of issues and regulations that they apply to
Regulatory requirements for GMPs
- Quality Assurance
- Training
- Documentation
- Laboratory Requirements
- Facilities
- Packaging and Labeling
- Consequences of noncompliance (including recent examples)
- Building a culture of compliance
- Review, Q&A
Session 1
- Seminar objectives review, expectations and scope
- Interview attendees regarding their specific responsibilities and needs
- Agreement on focus
- GMP vs. cGMP
- Compounding Facilities
- Emphasis on education and decision-making
- Training, memory retention, and accountability
- Notes on substandard product
Onboarding new employees
- Notes on Orientation
- Introductory GMP Training
- Curriculum Assignments
- Summary, Q&A, Knowledge check
Speaker
Michael Esposito has 30 years experience in the pharmaceutical industry and 13 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson’s McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations.He collaborated in the development and implementation of the training portion of the Consent Decree workplan for McNeil and revised their introductory GMP course. He is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.
Who Should Attend
- Quality Assurance Professionals
- Quality Control Analysts
- Manufacturing Supervisors and Managers
- Validation Professionals
- Regulatory Affairs Personnel
- R&D and Technical Operations Teams
- Compliance Officers
- Auditors and Inspection Readiness Teams
