Why Should You Attend:
Analytical methods play a critical role in development and manufacture of biologics. The methods should be suitable for intended use during different stages of development and for commercial manufacture of the product. Understanding regulatory expectations and requirements for the methods is important to develop and design methods that are not only suitable for intended purpose, but support manufacturing operations in release of the product in a timely manner. Biologics products being complex and of biological origin, often require biological methods to release starting materials, intermediates and final product. Focus on science and regulatory expectations during product development is essential to develop appropriate biological methods. It is also required that the methods must be maintained in a validated state with appropriate method performance during life cycle of the product.
In this presentation, an overview of the life cycle of an analytical method will be presented with emphasis on design of suitable method for intended purpose and maintaining sustainable compliance of the analytical methods during product life cycle.
Areas Covered in the Webinar:
Who Will Benefit:
Rajesh K. Gupta has a Ph.D. in microbiology and is the principal consultant at Biologics Quality & Regulatory Consultants, LLC. He has more than 35 years’ experience in the development, production, testing and regulation of biologics, working with both regulatory agencies and the industry. At FDA, CBER, he was a deputy director and the lab chief in the division of biological standards and quality control, managing lot release of biological products, regulatory reviews of analytical methods in the biologics license applications (BLA), generation of reference standards and development of new methods.
His previous experience includes his tenure at the Biologics Consulting Group, Wyeth, Chiron, Massachusetts Public Health Labs and National Institutes of Health (NIH) in USA, and at National Institute of Immunology and Central Research Institute in India. His major accomplishments are in sterility assurance for biological products, adjuvants and delivery systems for vaccines, polysaccharide-protein conjugate vaccines, combination vaccines and development and validation of analytical methods. In these areas, he has published more than 100 papers in peer reviewed journals and books and has made numerous presentations at scientific and regulatory meetings.
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. ComplianceOnline 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.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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