Annual GMP Training – Exploring Good Manufacturing Practices Updates and FDA Regulatory Expectations

Live Web Training II Part Course cGMP training
PART I: Thursday, October 7, 2010
PART II: Thursday, October 14, 2010Course Details
(1:20 p.m. – 3:45 p.m. EDT)
(12:20 p.m. – 2:45 p.m. CDT)
(10:20 a.m. – 12:45 p.m. PDT)Pricing
Instructor: Barry A. Friedman

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Introduction: Click here for course agenda

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

This live and interactive 2-session web training course will serve as a refresher course for those involved in the pharmaceutical and biotechnology arena. Highlights of the course will include the latest initiatives taken by Margaret Hamburg, M.D., the new Commissioner of Food and Drugs.  The course will review the six systems used by the FDA within their abbreviated and full inspection audits, and why they may choose one over the other.  Validations will be reviewed to include elements within the process, API, product, sterile product and cleaning of the total process/product equipment following use.  The Process Analytical Technology (PAT) initiative and its use within manufacturing will be updated.  Change control, its requirements and value, will be emphasized.  21 CFR Part 11 and, in particular, the management of electronic data to include the use of Excel and Access spreadsheets will be reviewed and recommendations provided.

This annual training course will also use Warning Letters to illustrate some of the common repeated errors that companies encounter within 21 CFR Parts 210/211 and how incorrect responses may amplify their problems.

The objective of this BenAstrum course will be to explore GMP updates and FDA regulatory expectations, and assist in assuring that your organization is maintaining itself within a cGMP compliance framework.

Course Discussion Points:

  • Latest initiatives taken by Margaret Hamburg, M.D., FDA Commissioner
  • Updates to the FDA 21 CFR Parts 210/211
  • The Six Systems involved in FDA abbreviated and full audits
  • Process Analytical Technology (PAT)
  • The management of electronic data based on 21 CFR Part 11
  • Reviewing how GMP compliance can make your organization more efficient
  • Understanding current FDA expectations through review of current Warning Letters
  • Using Warning Letter information to improve your facility’s performance and conformance to cGMPs
  • “Pitfalls” encountered with Warning Letter responses

Learning Benefits:

  • Where the FDA is headed under its new commissioner
  • Learning how GMP compliance can enhance the efficiency of your organization
  • Determining if your organization is meeting all six Quality System requirements
  • How to use a Warning Letter to improve the Quality within your facility
  • How a quick response to follow-up with training may not be the correct response to an FDA 483/Warning Letter
  • An opportunity to learn how others are meeting cGMP needs during the “live” Question and Answer period


Who Can Benefit:

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

Level: Fundamental Annual Refresher