San Francisco, California
London, United Kingdom
FDA has granted precious few applications for waiver since their CLIA Waiver guidance was published on January 30, 2008. Between 2008 and 2012, FDA reviewed 34 applications for CLIA Waiver and approved 14, sometimes taking years to issue a denial. The cost of performing CLIA Waiver studies, combined with the lengthy review times and likelihood of failure, has discouraged companies from bringing new innovations to this critical public health sector.
With the CLIA Waiver guidance appearing to be so prescriptive, why has denial dominated the review outcome?
By attending this this two-day workshop conference on Clinical Laboratory Improvement Amendments (CLIA) attendees will:
- Know how to submit a CLIA Waiver application that conforms to FDA’s CLIA Waiver guidance.
- Understand how the FDA determines performance requirements for CLIA Waiver and what to expect during their review.
- Learn how to design risk-based “flex” studies and develop cost-saving product development and clinical study strategies.
- Be able to review FDA’s CLIA categorization criteria and examine ways to incorporate “simple” and “negligible chance of erroneous results” into product design.
- Understand how CLIA Waiver requirements have evolved, FDA’s point of view and how to maximize your chances for a successful CLIA Waiver application.
Note: Use coupon code < NB5SQH8N > and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.