This two-day course is designed for those who work in a Current Good Manufacturing Practices (CGMP) environment and whose roles and responsibilities require they understand and apply quality principles inherent in in the regulations they must master and enforce.
This course begins by studying important concepts about the role and scope of quality and compliance and the resulting activities as quality and compliance work in multi-functional teams to achieve product safety and efficacy. Then, the GMP systems/elements (i.e. Facilities & Equipment, Personnel, CAPA, etc.) will be identified and categorized. Each category will be compared to each of GMPs to identify and study the similarities and differences providing insight concerning the function of their own GMP system.
This course is designed for personnel with all levels of cGMP experience. It will provide cGMP knowledge so they may advance and be prepared for additional responsibilities. Upon completion of this course, attendees will:
- Be able to understand and apply GMP concepts to decision making in a managerial role
- For the beginner, the course provides guidance on how cGMPs apply to their role and responsibilities and how to apply these principles in their daily activities
- For the intermediate & advanced, they will be able to apply what they have learned to better manage quality, solve problems, and make improvements
- To learn about ICH and IMDRF(GHTF) and harmonization documents and gain the perspective of how they may be applied to achieve compliance and improve products and processes to achieve greater customer satisfaction.
- Know the similarities and differences between the FDA's GMP Quality Systems for Active Pharmaceutical Ingredients (Q7A), Drug Product (Part 210/211), Biologicals (Part 600-680) and Medical Devices (Part 820 & ISO 13485)
- Learn the relationships of all the CGMPs to other FDA regulations and to the medical products life cycles
- Have working knowledge of international cGMP regulations
Who will Benefit:
As previously stated, this course is designed for all levels of quality, regulatory, and technical experience. It is also well-suited for many of the typical environments and medical products industry.
- It is ideal for the development, manufacturing, testing, and marketing of combination products because it presents an overall picture of the GMP’s required for combination products.
- For the virtual company, the course provides a guided tour of the product lifecycle and how the requirements for quality and compliance change from development to commercialization and onto post-approval.
- For contractors providing outsourcing to the medical industry, it provides guidance on fulfilling the client’s needs to meet compliance requirements.
- Suppliers to the industry will gain insight and knowledge that will assist them in meeting their clients’ needs for consistent high quality components.
Examples of positions that has the potential benefit include:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Manufacturing engineers
- Production engineers
- Design engineers
- Process owners
- Quality engineers
- Quality auditors
- Document control specialists
Use coupon code NB5SQH8N and get 10% off on registration.