ComplianceOnline

Understanding CFR Part 210-211 Requirements for Drug Products

Instructor: Jamie Jamshidi
Product ID: 700931
  • Duration: 90 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This webinar will discuss in detail all parts of the regulations set forth in part 210 and in parts 211 of 21 CFR chapters. Attendees will learn how to comply with these regulations.

Why Should You Attend:

21 CFR Parts 210-211 contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. In this presentation all parts of the regulations set forth in part 210 and in parts 211 of 21 CFR chapters will be reviewed and discussed in details.

Areas Covered in the Webinar:

  • What is CFR? The history and reason.
  • How to apply and comply with 21 CFR Parts 210-211.
  • Review most common CGMP deficiencies and FDA Observation.
  • Help manufacturers meet requirements of the Agency’s current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211).

Who Will Benefit:

This training applies to personnel / companies primarily in the pharmaceutical, and biotechnology industries. The employees who will benefit include:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • Engineering
  • All personnel involved in a U.S. FDA-regulated environment

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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