The U.S. FDA and EU's MDR require specific steps to be fulfilled to develop and/or transfer analytical methods to maintain accuracy.
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:
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:
John E LincolnPrincipal, 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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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