In the United States, in vitro diagnostic products are classified and reviewed under two separate FDA Centers, depending on whether the product is intended to be used to diagnose a condition, predict if a particular treatment will be effective or monitor the effect of a treatment, or if it is intended to be used in the testing of transfusable blood or cellular products.

In this audio conference we highlight the differences in the two product review processes between the Centers and provide insight into their expectations regarding information required in submissions and following product approval. Recent Guidance Documents issued by FDA are discussed.

This audio conference covers:

• Which FDA Center has primary review responsibility for which IVD products
• The importance of intended use, how it affects FDA classification and to which Center it will be assigned for review
• The main concerns of each FDA Center in reviewing submissions for approval/clearance
• The type of clinical data used in support of IVD submissions and the regulations surrounding collection of that data
• Post-marketing requirements for change notification and product deviations

About the speakers:

Ann Quinlan-Smith is President of Alquest, Inc. She has worked in the medical industry for 25 years in technical disciplines as well as in the areas of clinical, regulatory and compliance. She has managed both personnel and projects in these areas, including US and International strategy development and implementation.

Ms. Quinlan-Smith has an established background as an instructor and trainer, through her frequent speaking engagements at local industry meetings and her past participation on the faculty of the Biomedical Program at Anoka Ramsey Community College. Ms. Quinlan-Smith has a B.S. in Medical Technology, a Masters degree in Business Administration (MBA), and has earned the Regulatory Affairs Certification (RAC) distinction from the Regulatory Affairs Professional Society (RAPS).

Pamela J. Vaughan is Senior Principal Consultant at Alquest, Inc. She has worked in the medical industry for over 30 years in quality assurance, quality control, manufacturing, and regulatory affairs. She has extensive experience in developing and maintaining GMP compliant quality systems to support manufacture of drugs, biologics, IVDs and medical devices.

Her background includes design, construction, validation, and start-up of biologics and drug manufacturing facilities; production of injectable grade products, and production of monoclonal antibodies for therapeutic use. She has several years of management and supervisory experience, has provided in-house and third party quality audits and training, and is experienced with preparing INDs, DMFs, BLAs and PMAs. She is a member of the American Society of Quality (ASQ), the Henrici Society of Microbiologists, and Regulatory Affairs Professional Society (RAPS). Ms. Vaughan has a B.A. in Biology/Microbiology, has earned Regulatory Affairs Certification (RAC) from RAPS, and is an ASQ Certified Quality Auditor (CQA).

Who should attend?

• Clinical Research Managers
• Regulatory Managers
• Compliance Department Managers
• Study Managers
• Manufacturing Personnel

This audio conference is rated General Interest.