Analytical Methods Validation - 21CFR211.165(e)

One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products today is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this to the drug development process and have separately expanded method validation requirements in recent years. However, with only limited guidance, industry has been left to interpret how to adequately comply with the regulations.

Whether involved in method development, method validation, method optimization or method transfer, this 90-minute, accredited training course will provide a broad understanding of the method validation process and the difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements.

THIS TRAINING IS PART OF OUR GMP LABORATORY CONTROL PROFESSIONAL CERTIFICATION

• To enroll into the complete GMP Laboratory Control Certification Program CLICK HERE.
  This program includes 10 specific online courses for $2050.
• To learn more about our certification programs, visit our website at Certifications 

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