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Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products

 
  January 24, 2018  
     
 
CfPIE - The Center for Professional Innovation & Education, Malvern, PA USA
November 5 & 6, 2018


Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

Complex processes yielding complex products such as biologics and biopharmaceuticals demand numerous, non-compendial, and sometimes complex QC test methods to confirm manufacturing consistency and product quality. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC in biologic and biopharmaceutical companies. The course will cover validation of QC analytical test methods (e.g., electrophoretic, HPLC, peptide mapping, etc.), cell-based potency bioassays, immunochemical binding impurity assays and adventitious agent assays.

Who Should Attend

This two-day course is designed for those who perform, supervise, manage, audit, or oversee the validation of test methods for the quality control of biologic and biopharmaceutical products. This includes, but is not limited to, professionals in Analytical Development, Quality Control, Quality Assurance, and Validation groups. The course will also benefit those in other departments who find test method validation among their responsibilities.

While the course focuses on test method examples for biologics and biopharmaceuticals, the principles and practices of test method validation taught in this course are universal for all therapeutic pharmaceutical products.

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers:

Judy Carmody, Ph.D.

Specialties: Regulatory, Management

Judy Carmody, Ph.D., is the founder and Principal Consultant of Carmody Quality Solutions, LLC. a dynamic, innovative consulting agency that provides Quality services to the pharmaceutical, biologics and medical device industries.

Dr. Carmody is the former president of Avatar Pharmaceutical Services, a GMP CRO which she founded and led for over 8 years, prior to selling it in 2010. Since then she has held senior level positions in small and large pharma and has strengthened her knowledge of robust quality systems. With each custom-crafted solution she fulfills her vision of connecting everyday quality processes and procedures with the strategic needs of her client's business.

Prior to founding Avatar, Dr. Carmody spent 10 years in the (bio)pharmaceutical industry, developing methods for small molecules and oligonucleotides, managing QC, Analytical, and Validation groups. In addition to this solid grounding in pharmaceuticals, she worked at Waters Corporation's Applied Technology and Marketing groups where she developed novel separations methods with colleagues and (bio)pharmaceutical customers. At Waters, Dr. Carmody brought numerous new technologies to market through published papers and technical presentations both at world-wide conferences and leading (bio)pharmaceutical companies.

Scientific understanding underscores Dr. Carmody’s unique approach to solving the most challenging Quality or Analytical issues. A resume that spans roles in applied technology, marketing, bench chemistry, validation, quality management and several leadership roles provides the basis of Dr. Carmody’s approach to developing solutions. Her experience leverages the creative integration of technologies from diverse fields and enables these elements to be transformed into client solutions.

Dr. Carmody holds a PhD in Analytical Chemistry from Clark University in Worcester, Massachusetts.

 
Deadline for Abstracts: N/A
 
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=267
E-mail: info@cfpie.com
 
 
   
 
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