Our industry experts explain FDA's current Good Manufacturing Practice Regulation for Finished Pharmaceuticals and what it means to your organization. Learn what compliance with this regulation means to your business, current harmonization and implementation strategies, the primary impact of the regulation on pharmaceutical companies, and how to comply with the requirements.

This course includes comprehensive coverage of 21 CFR Part 210 CGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Part 211 CGMP for Finished Pharmaceuticals. Upon completion of this course you will have gained the background knowledge necessary to ensure your organization complies with CGMP regulations.

Course Objectives

• Understand the purpose and objectives of FDA's current Good Manufacturing Practice (CGMP) Regulation for Finished Pharmaceuticals.
• Analyze the meaning of the elements of the CGMP for Finished Pharmaceuticals.
• Appreciate the benefits of an integrated documentation structure.
• Compare the relationship between regulations and guidance documents in support of FDA compliance initiatives.
• Recognize the difference between regulatory compliance and system conformance.
• Learn how to read FDA inspectional observations (Form 483) and recognize situations warranting FDA warning letters.
• Map the requirements of the CGMP regulation versus your current system and identify improvements to support FDA compliance.
• Evaluate the significance of nonconformities and classify them for follow-up action.