ANALYTICAL METHODS VALIDATION FOR FDA COMPLIANCE

Course Topics Include: – FDA, ICH and USP Validation Requirements –  Applying Validation Studies Consistent with Method Purpose – GMP  Compliance during Validation – Validation Acceptance Criteria – Validation Statistics – Validation Protocol Workshop – Validation Reports – Revalidation – Method Transfer. Course description 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 verification or method transfer, this course will provide a broad understanding and “hands-on” knowledge of the method validation process and the difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements. Lectures will include not only theoretical basis and practical applications, but actual validationexamples of HPLC, GC, UV/Vis, AA and titration  methods for small organic molecules. Some of the more common mathematical and statistical treatments of validation data will also be discussed. Because of the tremendous effort that can be expended in conducting validation studies, efficiency of experimental design and documentation will be stressed throughout the discussions. Although the general principles in this course may be applied to methods for testing biological molecules and medical devices, the focus of this course is on the validation of methods for the analysis of small molecules and not the unique analytical procedures often used for testing products of a biological nature. who should attend This course is intended for individuals who have the responsibility for establishing the integrity of analytical methods for active pharmaceutical ingredients (APIs) or finished pharmaceutical dosage forms.  This course will benefit individuals in:  • R&D  • Quality Control  • Quality Assurance  • Technical Operations Regulatory affairs personnel as well as regulatory authorities  who are responsible for the review of such data will also benefit from this course. Learning objectives Upon completion of this course, you will be able to:  • Identify the current method validation requirements from FDA, ICH and USP guidance documents and from industry practices  • Design focused and efficient method validation protocols that meet all FDA CDER  regulatory requirements  • Demonstrate the knowledge to confidently establish validation acceptance criteria  • Explain the GMP expectations for validation  • Describe the key issues in documenting validation work and writing reports • Explain the requirements and common issues in method transfer and revalidation.