ComplianceOnline

NEW Guidance for Industry: CGMP for Phase I Investigational Drugs

Instructor: Jamie Jamshidi
Product ID: 701064
  • Duration: 90 Min

recorded version

$149.00
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Training CD

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This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND).

Review and evaluate the most current Guidance for Industry "CGMP for Phase I Investigational Drugs" effective dates of July 2008.This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials.

Areas Covered in the Webinar:

  • Introduction and background.
  • Scope.
  • Key elements.
  • Who should comply with this document?
  • Recommended CGMP elements for Phase I Investigational drugs.
  • General guidance for complying with statute.
  • Special manufacturing situations.
  • Statutory and Regulatory Requirements.

Who will benefit:

This webinar will provide valuable assistance to all personal in:

  • Pharmaceutical
  • Biotechnology industries

Instructor Profile:

Jamie Jamshidi, Biotech-Pharmaceutical Quality & Regulatory Advisor has over 27 years of industry experience, including small molecules and large molecule biologicals.

Jamie has a broad understanding of the entire drug development process for both large molecule proteins and small molecules. She has extensive knowledge of U.S. Regulatory Filings through product life cycle, FDA Current Good Manufacturing Practices (CGMP), Current Good Laboratory Practices (CGLP) and Current Good Clinical Practices (CGCP), European and Japanese drug manufacturing regulations, ICH guidelines, and Qualified Person (QP) requirements under EU Directives, and World Health Organization (WHO) regulations.

Jamie also has extensive experience in the development and commercialization of pharmaceuticals and biotechnology at all process stages, including Drug Substance (API), Drug Product, Packaging, and Labeling. She has given numerous lectures and talks in the areas of Quality and Regulatory in several colleges, universities and conferences globally. She is well known in bio/pharmaceutical industry for her passion and respect for laws and regulations in ensuring product quality.

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