Introduction to GLP/GMP Training – An Introduction to Meeting the Requirements of 21 CFR Part 58 and 21 CFR Part 210/211; Exploring Good Manufacturing Practices and FDA Regulatory Expectations

Live Web Training
Instructor: Barry A. Friedman, PhD

Knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) are required by the FDA to assure facility personnel maintain a current understanding of regulatory requirements.  These regulations utilize 21 CFR Part 58, 21 CFR Parts 210/211, 600 and 820 as the basis for understanding; however, many other documents to include FDA’s Guidance(s) for Industry, and various other policies, to include ICH Q7, Q8, Q9 and Q10, enhance the basis for these regulatory expectations.

This live and interactive BenAstrum web training will acquaint those newly involved in the regulatory world of GLP/GMP with the pharmaceutical and biotechnology arena. Highlights of the training will include the latest initiatives taken by Margaret Hamburg, M.D., the new Commissioner of Food and Drugs.  The training will compare and contrast requirements between GLPs and GMPs, and describe why many organizations that initially followed GLPs have gradually migrated to GMPs.  The training will review the six systems the FDA use within their abbreviated and full inspection audits and why they may choose one audit format over the other.  It will cover various aspects of GLPs non-clinical laboratory operations to include animals and their maintenance, use of Study Directors and lack of equipment and method validations.  The Process Analytical Technology (PAT) initiative and its use within manufacturing will be discussed.  21 CFR Part 11 and, in particular, the management of electronic data to include the use of Excel and Access spreadsheets will briefly be reviewed and recommendations provided.

The objective of this training is to explore GLP/GMP practices and FDA regulatory expectations, as well as assist in assuring that your organization is maintaining itself within a GLP/GMP compliance framework.

Discussion Points:

• Latest initiatives taken by the Margaret Hamburg, M.D., FDA Commissioner
• Learning how GLP/GMP compliance can enhance the efficiency of your organization
• Comparisons between GLP and GMP
• Determining if your organization is meeting all six  System requirements
• The management of electronic data based on 21 CFR Part 11
• Process Analytical Technology (PAT)

Learning Benefits:

• What do Margaret Hamburg’s, M.D., initiatives mean to your organization
• Learning why GMP compliance is better than GLP from a regulatory perspective
• Why select a contract organization based on GLP or GMP
• What the FDA’s six (drugs) or seven (medical devices) mean to your organization
• What to request of your vendors when seeking 21 CFR Part 11 equipment

Who Can Benefit:

Those who will benefit from this training include Regulatory Compliance, Quality Assurance, Quality Control, Manufacturing and Facilities professionals who are required to maintain standards of compliance consistent with the latest revisions of GLPs/GMPs, as well as those that use contract manufacturing and contract testing facilities.

Please click here for the course agenda