IAS December 2021 - Newspaper - Page 6
IAS NEWSLETTER December 2021
US FDA ASCA Pilot Program and Webinars
NCSLI Workshop
and Symposium
by Laura Uraine
The U.S. Food and Drug Administration (FDA) has recognized IAS under the Accreditation Scheme for
Conformity Assessment (ASCA) pilot program to accredit testing laboratories that perform premarket
testing for medical device companies. In this program, IAS accredits testing laboratories using the
standard ISO/IEC 17025 and the ASCA program specifications.
Relying upon international conformity assessment standards and a set of FDA-identified ASCA program
specifications, the pilot is intended to increase consistency and predictability in the FDA’s approach
to assessing conformance with FDA-recognized consensus standards and test methods eligible for
inclusion in the ASCA Pilot in medical device premarket reviews. Ultimately, the ASCA Pilot is intended
to help the FDA ensure patients have timely and continued access to safe, effective, and high-quality
medical devices.
IAS Participates in International
Meetings
IAS has held two webinars on this topic with the help of the US Embassies in Japan and Germany.
Here is a breakdown and recap of the stats from each webinar:
JAPAN
2-hour Webinar
by Karthik Easwar, P.E., P.Eng
GERMANY
May 20th
70 attendees
4 speakers:
90-minute Webinar
September 2nd
79 attendees
4 speakers:
Steve Knode – Deputy Senior Commercial Officer – U.S.
Embassy in Japan - Gave the Opening remarks
Brittany Banta – Commercial Attaché - U.S. Embassy in
Berlin – Gave the Opening remarks
Stacy Cho – Senior Policy Analyst, Standards and
Conformity Assessment Program at the U.S. Food and
Drug Administration (FDA) – gave presentation on the
Accreditation Scheme for Conformity Assessment Pilot
Program and it’s benefits.
Eric Franca – Biomedical Engineer and Senior Policy
Advisor – US Food and Drug Administration – gave a
presentation on The Accreditation Scheme for Conformity
Assessment (ASCA) Pilot: Streamlining Conformity
Assessment in Device Submissions
Dimitrios Katsieris –Senior Global Manager – Testing
Laboratories and Food Accreditation Programs - IAS –
gave a presentation on the IAS Accreditation Process for
the FDA ASCA Program
Dimitrios Katsieris –Senior Global Manager – Testing
Laboratories and Food Accreditation Programs - IAS –
gave a presentation on the IAS Accreditation Process for
the FDA ASCA Program
Pamela Gwynn - Principal Engineer ASCA Program
Manager - UL gave a presentation on the experience
of becoming accredited by IAS to the FDA ASCA Pilot
Program.
Pamela Gwynn - Principal Engineer ASCA Program
Manager - UL gave a presentation on the experience
of becoming accredited by IAS to the FDA ASCA Pilot
Program.
Senior Management
Meeting –
September 30, 2021
IAS staff participated in various International Laboratory Accreditation Cooperation
(ILAC), International Accreditation Forum (IAF), Asia Pacific Accreditation Cooperation
and Inter-American Accreditation Cooperation (IAAC) meetings over the 2021 September
to November months. Most of these meetings were held during the early hours of the
morning and attended by a multitude of IAS staff. IAS contributed and participated in many
of these discussions on multiple technically sensitive documents during these meetings.
These technical documents have immense impact on IAS and our accredited conformity
assessment bodies (CABs). IAS’s early intervention, comments, votes and inputs on these
documents ensured that these documents are published in a manner that promotes a level
playing field for not only IAS and our CABs but to harmonize practices at the global front.
Most of the ILAC/IAF/APAC/IAAC Tasks Force, Work Groups and General Assembly
meetings had varied attendances from 40 to more than 200 participants. Below are screen
shots of joining representatives of international accreditation bodies and stakeholders
worldwide. During these meetings, many representatives of industry associations,
scheme owners, accreditation bodies and other stakeholders shared their experiences on
post COVID assessments, evaluation of conformity assessment schemes, cross frontier
issues, fraudulent behavior, accreditation body (AB) scoping, communication strategies
on engaging regulators, and the World Accreditation Day 2022 theme. Other technically
scientific practices and documents were also discussed. Given the current threshold of the
post pandemic period and the need to return to normalcy, discussions on CAB assessment
and AB evaluation models took top precedence.
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IAS External Newsletter
Helga Alexander, Manager of the Calibration
Laboratory Accreditation Program for
IAS, delivered a tutorial on Internal
Auditing for 17025 Accredited Calibration
Laboratories, gave a presentation on the
importance of metrology knowledge for
testing laboratories, and attended several
committee meetings on accreditation,
metrology resources, and testing
laboratories. She also attended an NCSL
International Board of Directors’ Meeting,
where she learned that NCSLI members
would have an opportunity to vote for her
during the upcoming Board election. Helga
is expected to join the NCSL International
Board of Directors as VP, Southeast Division,
in January 2022.
The next 2022 meeting for ILAC and IAF is scheduled to be an in-person meeting in
Montreal, Canada.
IAS at the Cannabis
Science Conference
East
by Laura Uraine
The IAS team gathered at the home office in
Brea, California and virtually online to discuss
the progress of all IAS accreditation programs
and discuss future direction emphasizing on
growth opportunities. Each program manager
presented a 15-minute PowerPoint on their
program(s). Each presentation included an
update on the program and opportunities for
growth and improvement. This very productive
meeting consisted of four sessions and over
20 presentations. The IAS team looks forward
to sharing the outcomes of the discussion with
our customers and colleagues in the coming
months!
After the pandemic prevented the annual
National Conference of Standards
Laboratories (NCSL) International Workshop
and Symposium from taking place as an inperson meeting in 2020, IAS was ready and
eager to participate in this important annual
meeting of metrology professionals in 2021.
The annual meeting took place in Orlando
August 22-26. While attendance was much
lower than other years, it provided IAS staff
members Helga Alexander, Greg West and
Harry Makam with ample opportunity to talk
to prospective clients at the IAS booth.
IAS had a booth at the 2021 Cannabis Science
Conference (CSC) East at the Baltimore Convention
Center in Baltimore, Maryland, September 13-15.The
event was attended by IAS President, Raj Nathan, IAS
Customer Success Representative Duncan Millar,
and Technical Officer – Accreditation Support, Harry
Makam.
“On the first day we were very busy talking to people almost non-stop. A lot of the people
that spoke to us were interested in accreditation. Not all of them were from the conformity
assessment world, but a lot of people were very interested in learning about IAS and the role
IAS has in the cannabis industry. It was a great success!” noted Harry Makam.
www.iasonline.org
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