Analytical Test Methods Validation: FDA, ICH and USP Requirements

Why Should You Attend:

As products are developed from R&D through pre-clinical, clinical and commercial phases, the requirements for analytical test method validation also evolve to meet the increasing regulatory requirements. It is important to know when to do what - too much or unnecessary validation is costly and can delay development programs, while insufficient validation can mean rejection of an application.

This seminar will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation. We will cover the FDA, ICH and USP requirements, and illustrate the components of validation and ways to expedite the validation process.

The training will cover both small molecule test methods and biotechnology assays, and suggested parameters to validate in each case. The documentation associated with test method validation will also be reviewed.

Areas Covered in the Seminar:

• Regulatory requirements for test method validation.
• Phase-appropriate test method validation.
• Elements of test method validation.
• FDA, ICH and USP requirements for validation.
• Documenting test method validation.

Who will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and manufacturing services will also benefit.

The employees who will benefit include:

• End-users responsible for testing
• QA managers and validation personnel
• Analytical development managers and personnel
• Senior Quality, Facilities and R&D Management
• Quality Control staff
• Quality system auditors

Instructor Profile:

Dr. Rich Poser, is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as the vendors such as contract laboratories, instrument manufacturers, contract manufacturing sites and software developers that support these highly regulated industries.

Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. Following work in product development, laboratory automation, and validation and quality systems for the Mylan Pharmaceutical Company, Rich joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. After the acquisition of Dura by Élan, Rich was appointed Director of Quality Laboratory Operations and led their 21CFR Part 11 training and audit team.

Now in private practice as a quality consultant, he also lectures at UCSD Extension in validation, cGMP Regulations and analytical methods validation, and has presented or chaired public seminars on cGMP Requirements, Computer System Validation, Vendor Qualification Auditing, Analytical Methods Validation and Infrastructure Qualification.