Understanding 21 CFR 210 and 211
Duration: 2 Days = 1.4 CEUs
List PriceIn-House Training
$895.00Call for Quote

*Early bird discounts available for registrations 60 Days or more in advance.

Call for scheduling & pricing at your location

Course Objectives

This two-day course provides attendees with a basic introduction on the background and intent of the cGMPs (current Good Manufacturing Practices) as defined by 21 CFR part 210 and 211. Through the course, you will learn how to implement the GMPs in your organization, how to optimize their benefits and meet regulations.

Additionally, the class will review the current thinking of the FDA regarding Quality Systems approach to Pharmaceutical Industry.

Who Should Attend?

  • Product development scientists and technicians

  • Quality control/assurance personnel and management

  • Regulatory affairs personnel

  • Manufacturing management and personnel

  • Quality system implementation teams

  • Designated FDA contacts

Key Session Topics

  • Why the cGMPs were developed

  • Understanding the intent of the cGMPs

  • Detailed overview of the cGMPs

  • Developing the necessary skills to implement the cGMPs within your organization

  • Examining your current activities in the light of the cGMP

  • Determining how the cGMPs will benefit your procedures and how to show others the advantages available

  • Maximizing the benefits of employing the cGMPs

  • Verifying that regulations are satisfied

  • Adequately preparing for the next FDA audit; what the FDA looks for

How to Register

  • Online: Click the "Register Online Now" link to access the online registration form and pay by credit card.
  • Call: USA: 1-800-374-3818, CANADA: 1-877-426-0714. Group Bookings available!
  • Email: Training.Americas@saiglobal.com.