Current Good Manufacturing Practice and Quality System Regulation
Upon completion of this workshop, participants will be able to:
- Understand FDA, GMP, and QSR terms they are likely to encounter.
- Understand the intent of the GMP and QSR regulations.
- Have a thorough understanding of the breadth and scope of the GMP and QSR regulations.
- Interpret sections of the GMP and QSR regulations in order to apply them to real-world situations they are likely to encounter.
- Develop a personal commitment to comply with the GMP and QSR regulations.
- Recognize violations and potential violations of the GMP and QSR regulations.
Who Should Attend
This workshop is designed for anyone entering the FDA regulated industries whose job responsibility requires a comprehensive understanding of the basic concepts of GMP and QSR.
Our instructors all have management experience in the FDA regulated industries. They have first-hand experience dealing with the day-to-day challenges of maintaining a compliant workplace. Our instructors work hard to keep each participant engaged in active learning throughout the entire workshop.
Our approach is hands-on and practical, not theoretical. We use proven adult learning techniques, which includes a diverse array of group discussion, lecture, video, demonstrations, and small group interactive activities.
Day One - The Concept of Compliance
Day One consists of discussion around the specific topics listed below. GMP and QSR are explored from a compliance viewpoint. Small group exercises are used throughout the session to enhance learning. Participants will engage in a GMP audit using a videotaped scenario. Small group audit teams will then prepare a mock FDA-483 observation form and share their observations with the entire group. These small groups will then develop strategies to deal with each observation and more importantly, identify what could have been done to prevent the observation in the first place.
- Exploring the 8 P’s of GMP (Product, Process, Project, Paperwork, People, Patients, Position and Profit)
- How and why GMP makes Good Business Sense
- The why behind the GMP regulations. Exploring the intent of the regulations
- The history and evolution of Food and Drug law and the GMP regulations
- The concept of operating in a “state of control”
- The thirteen components of controlled GMP compliance, with particular focus on Documentation and Records control, Procedures control and the training necessary to deploy effective procedures, and Equipment and Facilities control
- Technical, Operational, and Relational aspects of GMP compliance
- An inside look at the FDA and how they operate
- Interacting effectively with FDA - Dos and Don’ts
- Conducting a mock GMP/QSR audit
- Identifying observations from the audit
- Developing recommendations to prevent audit observations
Day Two -The Challenge of Performance
Day Two consists of discussion around the specific topics listed below. Whereas on Day One the emphasis is on GMP from a Compliance viewpoint, this day focuses on GMP from a business performance perspective. A Case Study approach is used to identify the specific requirements of each section of the GMP and QSR regulations. Small groups are assigned certain sections of the regulations to examine in detail and prepare recommendations using the case study example.
- Identifying and understanding the Ten Principles of GMP.
- Defining the requirements for good procedures, record keeping and proper documentation
- Identifying the components of what constitutes an effective written procedure
- Identifying the challenges associated with written procedures
- Proving that our systems do what they are designed to do by validation and commissioning
- Integrating productivity, product quality, and employee safety into the design and construction of our facilities and equipment, and then properly maintaining our facilities and equipment
- Clearly defining, developing, and demonstrating job competence
- Protecting our products against contamination by making cleanliness a daily habit
- Building quality into our products by systematically controlling our components and product related processes such as manufacturing, packaging and labeling, testing, distribution, and marketing
- How to personally audit for GMP compliance and performance. Planned and periodic audits for compliance and performance
- A comprehensive GMP/QSR Case Study
- Identifying specific issues for your organization