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.
Judy Carmody, Ph.D., is the founder and Principal Consultant of Carmody Quality Solutions, LLC., a dynamic, innovative consulting agency that provides Quality services to the pharmaceutical, biologics and medical device industries.
Dr. Carmody is the former president of Avatar Pharmaceutical Services, a GMP CRO which she founded and led for over 8 years, prior to selling it in 2010. Since then she has held senior level positions in small and large pharma and has strengthened her knowledge of robust quality systems. With each custom-crafted solution she fulfills her vision of connecting everyday quality processes and procedures with the strategic needs of her client's business.
Prior to founding Avatar, Dr. Carmody spent 10 years in the (bio)pharmaceutical industry, developing methods for small molecules and oligonucleotides, managing QC, Analytical, and Validation groups. In addition to this solid grounding in pharmaceuticals, she worked at Waters Corporation's Applied Technology and Marketing groups where she developed novel separations methods with colleagues and (bio)pharmaceutical customers. At Waters, Dr. Carmody brought numerous new technologies to market through published papers and technical presentations both at world-wide conferences and leading (bio)pharmaceutical companies.
Scientific understanding underscores Dr. Carmody’s unique approach to solving the most challenging Quality or Analytical issues. A resume that spans roles in applied technology, marketing, bench chemistry, validation, quality management and several leadership roles provides the basis of Dr. Carmody’s approach to solution building. Her experience leverages the creative integration of technologies from diverse fields and enables these elements to be transformed into client solutions.
Dr. Carmody holds a PhD in Analytical Chemistry from Clark University in Worcester, Massachusetts.