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BIOTEKNICA COMMUNITY OUTREACH

BIOTEKNICA COMMUNITY OUTREACH Peru, Miami, Africa!  When not traveling around the world for client business, BioTeknica team members can be found reaching out to local and global communities, helping to make a difference. Beautifying the Community with Habitat for Humanity Recently, 11 BioTeknica Team members and their families joined Habitat for Humanity of Greater [...]

By |2021-02-12T03:08:16+00:00May 18th, 2020|Blog, Case Studies, S3 Compliance Matters|0 Comments

TEAM MEMBER PROFILE Meet Ruben Capo: Co-Founder, Quality Engineer, Part-Time Adventurer

Meet Ruben, mild-mannered BioTeknica Principal, Co-Founder, and Senior Quality Engineer. Think you know him? Think again. When you talk to clients about Ruben Capo, you hear things like he “provided the insight, expertise and leadership in leading the process validation effort,” or he “is very knowledgeable and an excellent consultant for regulatory matters.” [...]

By |2021-02-12T03:09:08+00:00May 18th, 2020|Blog, S3 Compliance Matters|0 Comments

SUCCESS STORIES Bringing an Inadequate CAPA Process to Effectiveness

Did you know that one of the top three causes of 483 observations is because manufacturers fail to correctly use their CAPA processes? How did BioTeknica help a client with an ineffective CAPA process eliminate repeat CAPAs for similar nonconformance events? The results were startling. CAPA ABCs As the “Do Re Mi song” says, [...]

By |2021-02-12T03:14:17+00:00May 18th, 2020|Blog, S3 Compliance Matters|0 Comments

ASK A BIOTEKNICA SME HOW TO VALIDATE A PROCESS WITH A “HIGH DEGREE OF ASSURANCE” AND WHAT DOES THAT EVEN MEAN?

Looking for answers to your regulatory questions? To submit one, please click on Ask a BioTeknica SME and our Subject Matter Experts (SMEs) will share their insights. Today, SME Saeid Ebrahim explains how to validate with a high degree of assurance. Please be assured that in the event of further disruptions, we are [...]

By |2021-03-22T20:51:10+00:00May 18th, 2020|Blog, S3 Compliance Matters|0 Comments

ASR IS OVER! HOW DO VMSR & NEST IMPACT YOUR ORGANIZATION?

Feeling unsure of how the FDA’s updated reporting processes will affect you? You’re not alone. BioTeknica SMEs delved into the real-world impact of these new reporting programs at a recent conference. Click below to get their Top 5 MDR tips. Please be assured that in the event of further disruptions, [...]

By |2021-02-12T01:52:54+00:00May 18th, 2020|Blog, S3 Compliance Matters|0 Comments

KEY FDA EXPECTATIONS FOR ADVERSE EVENT REPORTING DURING A PANDEMIC

The FDA has modified the regulations regarding adverse event reporting during a pandemic to include COVID-19. Click below for key points about the updated guidance as of March 2020. Please be assured that in the event of further disruptions, we are prepared to continue with our services remotely in a [...]

By |2021-02-12T01:51:13+00:00May 18th, 2020|Blog, S3 Compliance Matters|0 Comments

TO YOU, FROM US

The COVID-19 pandemic has hurled us all into uncharted territory. We question our collective truths; wonder who we are as a nation; ponder our priorities, how we take care of one another, stay healthy, keep our businesses afloat, teach our children, support our heroes, and lift our most vulnerable, all while attempting to keep [...]

By |2021-02-12T01:50:34+00:00May 18th, 2020|Blog, S3 Compliance Matters|0 Comments

2 New Laws Impact Device Industry

2 New Laws Impact Device Industry According to a presentation by FDA official Blake Bevill, two recent laws will impact the device industry: 1. Food and Drug Administration Re-Authorization Act (FDARA) of 2017 2. 21st Century Cures Act FDARA Highlights The FDA Reauthorization Act of 2017 (FDARA), an amendment to the Federal Food, Drug, and [...]

By |2021-02-12T03:26:12+00:00October 5th, 2018|Blog, S3 Compliance Matters|0 Comments

4 Strategies for Keeping Current In An Evolving World of Compliance

4 Strategies for Keeping Current In An Evolving World of Compliance At a half-day conference of the American Society for Quality (ASQ) conference whose theme was Quality is Not a Goal – It’s a Way of Life, Julie Larsen provided industry professionals essential tips and best practices to stay current as compliance trends evolve. [...]

By |2021-02-12T03:26:03+00:00October 5th, 2018|Blog, S3 Compliance Matters|0 Comments

Validation: When is a Test Method Not a Test Method?

Validation: When is a Test Method Not a Test Method? How can one site conduct and pass several gage Repeatability and Reproducibility (R&R) studies on a product, yet another site fails the gage R&R on the same product using the same gage and the same test methods?  In his presentation to industry professionals at [...]

By |2021-02-12T03:25:52+00:00October 5th, 2018|Blog, S3 Compliance Matters|0 Comments
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