Recorded Webinar: Understanding the FDA ASCA Program

About this Webinar

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.

Takeaways:

• Overview of the FDA ASCA program;
• Requirements for program participation;
• Benefits of participation;
• Overview of basic safety guidance;
• Overview of biochemistry guidance.

Speakers

Jason Stine | Senior Director of Accreditation @ ANSI National Accreditation Board (ANAB)

Jason is in charge of accreditation activities relating to testing laboratories and supporting programs accredited by ANAB. He has worked for ANAB and has been qualified as a Lead Assessor for over 15 years performing hundreds of assessments. Jason has a degree in Mechanical Engineering Technology from Purdue University and over 10 years of technical experience working in various accredited testing laboratories prior to ANAB. He is involved with technical organizations such as ASTM, ASQ, SAE, AOAC, ACIL and works closely with many state and federal agencies such as the EPA, FDA, CPSC and DoD on technical and accreditation related programs. He is actively involved in representing ANAB internationally and nationally in accreditation activities with APAC, IAAC, ILAC, and NACLA. He is the ANAB APAC delegate for MRA council lab-related decisions. Also, he is a trained and qualified ISO/IEC 17011 APAC lead evaluator.

Karen Arrivillaga | Account Executive @ Qualtrax

Karen has been with Qualtrax since 2015, with a focus in the laboratory space. Karen has more than six years of experience selling technology solutions and is passionate about finding the best ways to use software to manage accreditation, simplify compliance, and inspire a culture of quality. She’s a proud member of the Qualtrax internal audit team, which recently assisted with our transition to ISO/IEC 9001:2015. Karen graduated from Virginia Tech with a Bachelor’s in Consumer Economics.

Interested in more webinars?

If you liked this webinar, you might be interested in a webinar we recorded with Melanie Ross, Training Products Specialist at ANAB, on cause analysis and corrective action.

Find upcoming webinars on our Event Calendar and more recorded webinars on our Videos page.

Categories: Manufacturing, Quality Managers