The Center for Professional Innovation & Education, Malvern, PA
10/15/08
Who Should Attend This regularly updated three-day course is designed for those who work in a Current Good Manufacturing Practices (CGMP) regulated environment within a Pharmaceutical, Biopharmaceutical, or Biologics company. This includes, but is not limited to, Compliance, Development, Manufacturing and Production, Quality Assurance, Quality Control, and Regulatory Affairs. The course will also be of benefit to mid and senior-level managers whose span of responsibility includes functional areas that require CGMP compliance. Regular training in the CGMPs is itself an FDA requirement: “Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.” – 21 CFR 211.24(a).
Learning Objectives This course is designed to provide the necessary prerequisites to become a CGMP expert. Upon completion of this course you will: - Be conversant in the specialized language of CGMP compliance
- Be thoroughly familiar with the CGMPs as contained in 21 CFR, Parts 210, 211, and 600 – 680
- Have working knowledge of the European CGMPs
- Know where to look to get your CGMP questions answered quickly
- Know the current compliance “hot spots” that FDA and European authorities look for when inspecting for CGMP compliance
- Be able to predict regulatory trends to maintain a high state of compliance
- Understand how to most easily keep your CGMP compliance knowledge up to date
Course Description
This course is intended to give participants a thorough grounding in the Current Good Manufacturing Practices for both the US and Europe. Day 1 provides a comprehensive introduction to international CGMPs and is also a good refresher for those already experienced in CGMP compliance. Day 2 covers intermediate level topics such as compliance “hot spots,” deviations, out-of-specification results, risk analysis, and auditing for compliance. Day 3 covers advanced topics such as compliance during development, effective compliance strategies, current hot topics, predicting regulatory trends, and shortcuts for staying at the forefront of compliance knowledge. The course concludes with an interactive exercise designed to test your knowledge of CGMP regulations. Additional benefits of this class include: - Learning not just from the course director, but tapping into the knowledge of your peers: Participants may anonymously submit their top CGMP challenges, problems, and issues for classroom discussion
- Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 20 years of industry experience, more than 8 years of consulting experience, and over 10 years directing CGMP training courses
- Participants receive a Resource CD with: a Reference List, 483s, Key Guidance Documents, and more
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