Monthly Archives: May 2020

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

INDUSTRY NEWS ROUNDUP

Due to the COVID-19 pandemic, the Association of Food and Drug Officials (AFDO) Annual Conference, originally scheduled for June 2020 in Phoenix, AZ, has been canceled. BioTeknica is actively helping AFDO plan for medical device webinars to be held later this year. For the latest information on the webinars and new annual conference date, [...]

By |2021-02-12T03:13:32+00:00May 18th, 2020|News, Newsletter, Press Releases|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

BIOTEKNICA OPERATING AT FULL CAPACITY Company Implements Business Continuity Plan During COVID-19 Crisis

BioTeknica and its sister companies, Qualified Data Systems and Synergis, are here for you. We are open and operating at full capacity with the ability to access client technology systems remotely, when necessary. Learn about key elements of our continuity plan… Please be assured that in the event of further [...]

By |2021-02-12T03:17:19+00:00May 18th, 2020|News, Press Releases|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
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