Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in each country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping. These requirements include the required education, training and experience for employees whose activities affect the quality of drug products. Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training.
The goal of this seminar is to enable you to:
- Demonstrate a basic knowledge of GMP requirements
- Interpret these requirements for your day-to-day operations
- Avoid the negative consequences of noncompliance
- Instill a culture of compliance in your organization
The subject of introductory GMP includes a discussion of the pivotal events that have shaped US laws on food, drugs and cosmetics; use of the terms GMP and cGMP (Current Good Manufacturing Practices); key sections in the US Code of Federal Regulations that impact drug manufacture; and how an organization can remain compliant with these regulations in their day-to-day operations.
Why should you attend:
The laws that govern Good Manufacturing Practices (GMP) are a cornerstone of pharmaceutical production. Still, many companies fall short of the requirements that are written into US, UK, European and other laws, which can have disastrous consequences for patient health and a company's reputation, not to mention the resultant losses in revenue due to fines, declining sales and withdrawal of products from the market. It is expected that all employees who are involved in pharmaceutical production will attend GMP-related training on a regular basis.
Areas Covered :
- Food and drug oversight
- Pivotal events that shaped laws in US and scope of FDA actions
- GMP vs. cGMP
- Consequences of noncompliance
- Building a culture of compliance
- Emphasis on education and decision-making
- Training, memory retention, and accountability
- Avoiding over-reliance on metrics
- Recent trends in GMP enforcement and lessons learned
Who will Benefit:
This course will be of benefit to anyone whose responsibilities fall under the umbrella of manufacturing, packaging or distribution of pharmaceutical products (e.g., Quality Assurance, Packaging, Operations, Planning).
- 8:30 AM - Registrations Start
- 9:00 AM - 9:30 AM
- Seminar objectives review, expectations and scope
- Interview attendees re their specific responsibilities and needs
- Agreement on focus
- 9:30 AM - 10:30 AM
- 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
- 10:30 AM - 10:45 AM Break
- 10:45 AM - 12:00 PM
- Regulatory requirements for GMPs: quality assurance, training, documentation, laboratory requirements, facilities, packaging and labeling
- Review and Q&A
- 12:00 PM - 1:00 PM Lunch
- 1:00 PM - 2:30 PM
- Regulatory requirements for GMPs: quality assurance, training, documentation, laboratory requirements, facilities, packaging and labeling (continued)
- 2:30 PM - 2:45 PM Break
- 2:45 PM - 4:00 PM
- Consequences of noncompliance (including recent examples)
- 4:00 PM - 4:30 PM
- Building a culture of compliance
- Review, Q&A
- 5:00 PM End of Day 1
- 9:00 AM - 9:30 AM
- Seminar objectives review, expectations and scope
- Interview attendees re their specific responsibilities and needs
- Agreement on focus
- 9:30 AM - 10:30 AM
- GMP vs. cGMP
- Compounding facilities
- 10:30 AM - 10:45 AM Break
- 10:45 AM - 12:00 PM
- Emphasis on education and decision-making
- Training, memory retention, and accountability
- Notes on substandard product
- Review, Q&A
- 12:00 PM - 1:00 PM Lunch
- 1:00 PM - 2:30 PM
- Onboarding new employees: notes on orientation, introductory GMP training, and curriculum assignments
- 2:30 PM - 2:45 PM Break
- 2:45 PM - 4:00 PM
- Onboarding new employees: notes on orientation, introductory GMP training, and curriculum assignments (continued)
- 4:00 PM - 4:30 PM
- Summary, Q&A
- Knowledge check (optional)
- 5:00 PM End of Day 2
Michael Esposito
Principal, TrainReach Consulting, LLC
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 work plan 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.
