Understanding Biopharmaceutical CGMPs

Onsite Training & Consulting
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Course Description

Ensure that your organization is fully compliant with the biopharmaceutical regulations to avoid greater regulatory scrutiny that could lead to more FDA inspections, 483s, warning letters, and additional, costly enforcement actions.

In this detailed review, you will gain an understanding of the FDA’s CGMP requirements that will enable your organization to become fully compliant. FDA expects organizations to incorporate a compliant quality system approach into all aspects of their business across the entire product life cycle. It is critical for you to understand regulatory requirements to protect your organization from noncompliance issues before they occur.

This is an introductory course designed for employees working in the pharmaceutical and biotechnology drug product operations. 

For a a deep knowledge of the fundamentals of both domestic and international biopharmaceutical regulations, follow this courses with Understanding International Biopharmaceutical CGMPs (course code INP).



CEUs:2.5
Number of days:3
Code:MGP
Cost:$2195.00

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Course Objectives
  • Understand the historical background of drug regulations and their impact on the current regulatory environment.
  • Describe the structure and the role of the Food and Drug Administration.
  • Recognize differences between pharmaceutical and biotechnology products and regulations.
  • Identify the fundamentals of working in a CGMP-regulated environment.
  • Understand the importance of following procedures and CGMPs and the consequences of noncompliance.
  • Describe the significance of FDA’s Quality System Inspection Technique in auditing biopharmaceutical organizations.
  • Compare and contrast drug CGMP and quality system regulations.
  • Identify inspectional trends using FDA 483 observations, warning letters, and FDA’s statistical data.
  • Create a plan for complying with current FDA regulatory requirements to avoid enforcement action.
  • Explain the FDA’s risk-based initiative and future trends.
  • • Understand the role of international regulatory agencies and the significance of the International Conference on Harmonisation (ICH) on domestic drug product manufacturing.
Topics
  • Structure of FDA and the role of its functional areas in the regulation of biopharmaceuticals
  • Achieving and maintaining a state of control as a part of an overall business compliance strategy
  • Pure Food and Drug Act
  • Food, Drug and Cosmetic Act
  • Drug regulations: 21 CFR Parts 210 and 211
  • Biologics regulations: 21 CFR Parts 600, 601, and 610
  • Recent FDA enforcement trends, 483 inspectional observations, and warning letters
  • FDA challenges and future initiatives
  • FDA’s “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations”
  • International harmonization efforts through ICH Q10 and other initiatives
Who Should Attend

This is an introductory course designed for employees working in pharmaceutical and biotechnology drug product operations.

Upcoming dates and locations
Please contact us if you need additional information or if you don't see a date that works for you.
To register by phone, call 800.472.6477

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Course Name On-Site Public Dates
Location Start Date Days Cost Registration
Understanding Biopharmaceutical CGMPs CONTACT US Chicago, IL 06/18/2012 3 $2195.00 Add to Cart
Understanding Biopharmaceutical CGMPs CONTACT US Princeton, NJ 07/16/2012 3 $2195.00 Add to Cart
Understanding Biopharmaceutical CGMPs CONTACT US San Francisco, CA 08/06/2012 3 $2195.00 Add to Cart
Understanding Biopharmaceutical CGMPs CONTACT US Chicago, IL 09/24/2012 3 $2195.00 Add to Cart
 
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