Analytical Method Development, and Method Transfer

Description:

The development and transfer of an analytical method is a formal documented process that qualifies a laboratory to use a method that originated in another laboratory. The transfer procedures ensure that the receiving lab has the procedural knowledge and ability to perform the procedure exactly as intended, yielding the expected results. Analytical methods are commonly transferred from the originating site to other laboratories during the clinical, scale-up, or commercialization phases of product development. The methods may be transferred several times to more than one laboratory anywhere in the world over the product's lifecycle. The knowledge associated with the routine and successful operation of a method must be part of such transfers. Then, it must be clearly demonstrated and documented that the receiving laboratories can run the method and obtain the same results with the same accuracy and precision as the developing laboratory.

Why Should You Attend:

Analytical methods are typically developed and validated in Research and Development (R&D) laboratories and transferred to other laboratories and sites during the method and product lifecycle. 1 The transfer must be successfully completed and documented for the receiving laboratory to report official (current good manufacturing practice [CGMP] and good laboratory practice [GLP]) data to the regulatory authorities. 2 Due to the importance of the method transfer, there is significant regulatory concern in the methods required and proof of compliance in the documentation required.

Areas Covered in the Webinar:

Participants will learn how an effective Test Method Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety.

Issues to be covered include:

• Assure product quality from formal test method development and transfer
• FDA Analytical Test Method development bnd transfer guidelines
• Applicable GLP requirements
• Major steps in test method development and transfer
• Critical considerations

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to implement, modify,and/or audit their Test Method development, transfer and documentation. This webinar applies to personnel / companies in the Pharmaceutical, Diagnostic, and Biologics fields with some application to Devices and Combo products. The employees who will benefit include:

• Senior management
• R & D
• Quality Assurance / Regulatory Affairs
• Production
• Engineering, including Software
• All personnel involved in development and/or transfer of analytical test methods and their documentation.

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. Mr. Lincoln is a graduate of UCLA.

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