Richard Poser
Instructor Richard Poser
Product Id 600475
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Analytical Test Methods Validation for GxP Laboratory Compliance: FDA, ICH and USP Requirements

Overview:

This Validation training 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.

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. We 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 be reviewed.

Areas Covered in the Session:

  • 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

Speaker Profile
Richard Poser, PhD 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. Following an academic career in drug metabolism and chemotherapy, Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. He joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. Following acquisition of Dura by Elan, 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 and has presented or chaired public seminars on cGMP Requirements, Computer System Validation, Vendor Qualification Auditing, Analytical Methods Validation and Infrastructure Qualification.

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