Method validation is legally required to show regulatory authorities that your organization’s method is appropriate for its intended use. If not performed properly, method validation can cause delays in product approval and regulatory problems during commercialization.
Inadequate method validation remains a significant problem during pharmaceutical, biopharmaceutical, and biological product development, approval, and commercial production. The most common mistakes include inadequate method characterization, deficient handling of deviations and discrepancies, inadequate Validation Reports, and not revalidating when necessary. Knowing how to avoid these mistakes will ensure successful validation of analytical methods during Phase III and beyond.
This 90-minute interactive seminar will use the guidance provided by ICH Q2 as a foundation and go beyond to show you how to best prepare and execute your methods validation strategy.
Learn to look out for and avoid common pitfalls including:
• The top 10 mistakes people make before starting validation (including inadequate Protocols, failure to formally qualify equipment, deficient robustness studies and more)
• Frequently-seen mistakes made during method validation (including non-compliant handling of Protocol deviations, inadequate oversight of validation done by contract labs, and more)
• Common errors made after method validation work is completed (including deficient Validation Reports, not tracking and trending the method and more)
In addition, this course will include recent case histories of validation mistakes drawn from FDA Warning Letters and Notices of Deficiency (483s), and how these errors can be avoided. An Annex will be included containing validation deficiencies cited by FDA in the last 5 years.
This course will be of benefit to methods development scientists, QC analysts, laboratory managers, validation specialists, QA managers and staff, and anyone involved with regulatory affairs and GMP Laboratory Control Systems compliance.
Thomas J Pritchett, Ph.D., has worked with US, European, and Canadian pharmaceutical,biopharmaceutical, and biologics industries for more than 25 years, during which he hasgained considerable experience in regulatory and technical aspects of Quality Assurance, Quality Control and CGMP Compliance for both investigational and marketed products. He is also an experienced teacher, and has been directing courses for the Center for Professional Advancement since 1995. In addition, Dr. Pritchett has provided training sessions for the US FDA and for regulators and industry professionals in the Gulf Cooperation Council (GCC). Dr. Pritchett is also an active industry consultant and the co-founder/publisher of the newsletter BioQuality (www.bioquality.biz).