Understanding the FDA ASCA Program
Wednesday, February 24, 2021
In this webinar, we will review the new Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program launched by the FDA. This pilot is a voluntary program for accreditation bodies, medical device manufacturers, and testing laboratories to enhance confidence in medical device testing and validity of test results through accreditation to ISO/IEC 17025:2017 and the ASCA program specifications. ASCA accreditation to ISO/IEC 17025:2017 and the ASCA program specifications not only enhances confidence in the test results but also promotes consistency in test methods and supports international harmonization through the use of the international standard. Interested in learning more? Join us for this information-packed webinar!
- Overview of the FDA ASCA program;
- Requirements for program participation;
- Benefits of participation;
- Overview of basic safety guidance;
- Overview of biochemistry guidance.
Jason Stine, ANAB Senior Director of Accreditation, is in charge of accreditation activities relating to testing laboratories and supporting programs. He has worked for ANAB and been qualified as a lead assessor for more than 15 years.
Stine has a degree in mechanical engineering technology from Purdue University and more than 10 years technical experience working in accredited testing laboratories. He is involved with technical organizations such as ASTM, ASQ, SAE, AOAC, and ACIL and works closely with many state and federal agencies on technical and accreditation-related programs.
Stine represents ANAB nationally and internationally with APAC, IAAC, ILAC, and NACLA. He is a qualified ISO/IEC 17011 APAC lead evaluator and regularly participates on evaluation teams performing international evaluations of accreditation bodies worldwide.