GMP Fundamentals for the Pharmaceutical Industry (G01)
Overview
This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process. This includes a discussion of the FDA Systems Based Approach to inspections (Compliance Document 7356-002). In addition, participants will investigate the science behind the requirements, the people side of GMP, the challenge of defending products against contamination, how to consistently build quality into products, and how to personally audit for GMP compliance and performance. The course will conclude with a discussion on the basic GMP requirements related to facility and equipment controls.
What You Will Learn
- Explore GMP principles and approaches for active pharmaceutical ingredients (APIs), excipients, and finished pharmaceuticals
- Learn easy-to-grasp basics of regulatory requirements, current issues, and trends in the pharmaceutical industry with an emphasis on applying GMP in day-to-day operations
- History of the GMP regulations, the regulatory process, and the concept of operating in a "state of control," with an emphasis on the regulation of pharmaceutical products
Resources and Activities
- Pre-Course Work Materials
- Interactive Exercises
- Learning Assessments
Course Modules
- Introduction and History
- The FDA & System Inspections
- Equipment Requirements
- GMPs Up Close & Personal
- Facility Requirements
- Contamination Control
- Auditing
- USP, Europe, & PIC/S
Who Should Attend
- Quality assurance, quality control, regulatory affairs, validation, manufacturing, technical support, IT, supply chain, and engineering professionals who need a fundamental understanding of the GMPs related to pharmaceutical operations
- All levels of management who require a refresher course to stay current with GMP regulations and brush up on relevant skills
- Service organizations, suppliers, and vendors who serve pharmaceutical industry clients
Additional Course Details
Participants can expect open class discussions, sample problems, and an examination of the text of the regulation CFR 21, Parts 210 and 211 and/or the EU GMP guidelines. Throughout the course, we will emphasize positioning GMP as a tool for successfully coordinating, controlling, and improving quality, and developing regulatory control strategies. GMP will be presented as an opportunity to integrate product quality and regulatory compliance with performance. The course will provide all participants with the confidence to apply GMP to their specific job responsibilities and the comfort level to interact with fellow employees concerning GMP issues, as well as build a foundation for making GMP a lifestyle at their companies.
This course is presented in the U.S. and in Europe. For U.S. participants, emphasis will be placed on the requirements of the FDA. In Europe, both FDA and European requirements will be addressed, with the emphasis structured to meet the requirements of the delegates.
Learning Objectives
- Explain U.S. and European regulatory requirements and the origin, status, and legal basis of the FDA, and describe how EMEA and European directives fit into the regulatory picture
- Discuss the hierarchy of laws, directives, regulations, guidelines, and guidance documents
- Apply a fundamental knowledge of GMPs related to pharmaceutical industry operations
- Demonstrate a better understanding of how regulatory authorities review the production of pharmaceutical products
- Recognize GMP problem areas before they create issues
- Identify the key control areas associated with pharmaceutical operations that are required for compliance: technical (buildings, equipment, and materials); operational (policies, procedures, and records); and relational (employees, suppliers, and customers)
- Find current information regarding regulatory authority activities
- Prepare for a regulatory inspection and learn best practices on how to handle an inspection