The Center for Professional Innovation & Education (CfPIE), Malvern, PA
Jan 10-12, 2007
Who Should AttendThis 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-level and senior managers whose span of responsibility includes functional areas which 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 very familiar with the CGMPs as contained in Title 21 of the Code of Federal Regulations, 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 ________________________________________ COURSE AGENDA DAY ONE
Session 1
Introduction
What are your top CGMP challenges, issues, and problems?
A brief history of drug, biologic, and biopharmaceutical regulation
Demystifying the jargon of CGMP compliance: An abbreviation and acronym primer
The Essential Habits of CGMP Compliance
The costs of non-compliance Session 2 The two fundamental Acts underpinning the U.S. CGMPs
A brief introduction to FDA
The Big Picture: How the CGMPs fit into the total regulatory picture
US v. Barr: what you must know about this landmark case and why
Comprehensive review and explanation of the U.S. CGMPs:
• Part 210
• Part 211 Subpart A: General Provisions
• Subpart B: Organization and Personnel
• Part 211 Subpart C: Buildings and Facilities
• Subpart D: Equipment
• Subpart E: Control of Components and Drug Product Containers and Closures Session 3 Comprehensive review and explanation of the U.S. CGMPs, continued.
• Subpart F: Production and Process Controls
• Subpart G: Packaging and Labeling Control
• Subpart J: Records and Reports
• Subpart K: Returned and Salvaged Drug Products
21 CFR Parts 600 – 680, the Biologics CGMPs
The what, why, where, and when of FDA guidance documents
Essential guidance documents to guide your compliance efforts, including discussion of key points that you must know from guidance for industry documents and guidance documents for FDA personnel Session 4 A brief introduction to the European Regulatory Landscape
The fundamental Directive underpinning the European GMPs
Comprehensive review and explanation of the E.U. GMPs
Comparing and Contrasting the U.S. and E.U. GMPs
The International Conference on Harmonization: what it is and why you need to keep up with its activities DAY TWO Session 1 Detailed discussion of participant questions, problems, and issues
The importance of the Preamble to the U.S. CGMPs
The proposed amendments to the U.S. CGMPs and why you should study these
Top CGMP problems FDA sees at companies
Top CGMP problems for U.S. companies exporting to Europe Session 2 Effective handling of Deviations and Out Of Specification Results: how to stay out of regulatory hot water
Essential Documentation
Conducting effective Lab, Failure, and Complaint investigations
A basic root cause analysis primer and why this is essential
Corrective and Preventative Actions: Develop, Implement, Track
Change control Session 3 CGMPs for the 21st Century: What does FDA mean by this and how should your company react?
A Quality Systems approach to CGMP compliance
Responsibilities of upper management
A basic risk analysis primer and why this is crucial Session 4 Preparing for inspections
The 6-System inspection model currently used by FDA
How to use FDA inspection results to audit, enhance, and maintain CGMP compliance
Self-Inspection and Self-Auditing
CGMP Compliance for outsourced activities
Quality Agreements
External Auditing DAY THREE Session 1 Compliance during clinical development: How much is enough? How much is too much?
Change Capture
Development Reports
Exploratory INDs: A new concept in clinical compliance Session 2 Compliance self-assessment
Effective use of Compliance Master Plans
21 CFR Part 11 and CGMP Compliance
Essential ingredients of an effective CGMP compliance strategy Session 3 Regulatory Update: Current Hot Topics and CGMP Trends
Review of important FDA Notices of Deficiency (483s) and Warning Letters
Predicting regulatory trends Session 4 Shortcuts for keeping your CGMP knowledge at the cutting edge
GMP Jeopardy game
References and Resources for further study
Final Question and Answer Period
Course wrap-up and conclusions
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