FEATURED POST
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 our anxieties in check. Together we grapple with these questions as a nation, small communities, and as businesses, families, and individuals.
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 [...]
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 [...]
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 [...]
TO YOU, FROM US
The COVID-19 pandemic has hurled us all into uncharted territory. We question our collective truths; wonder who we are [...]
2 New Laws Impact Device Industry
2 New Laws Impact Device Industry According to a presentation by FDA official Blake Bevill, two recent laws [...]
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 [...]
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 [...]
S3 Method – Simple, Systematic, Sustainable
S3 Method: Simple, Systematic, Sustainable Can You Be Compliant While Keeping Costs Down & Positively Impacting Your Bottom Line? [...]
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. [...]
INDUSTRY NEWS ROUNDUP
Due to the COVID-19 pandemic, the Association of Food and Drug Officials (AFDO) Annual Conference, originally scheduled [...]
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 [...]
FDA’s Office Of Regulatory Affairs Realigned
FDA's Office Of Regulatory Affairs Realigned The FDA’s Office of Regulatory Affairs (ORA), the lead office for agency field activities, has changed its [...]
New FDA Communications Guidelines For Inspections
New FDA Communications Guidelines For Inspections Medical device companies have new FDA contacts and new guidelines to communicate with the FDA regarding their [...]
Modernizing the FDA Workforce
Modernizing the FDA Workforce A strategic priority identified by the FDA earlier this year is to strengthen the FDA’s scientific workforce by investing [...]
BioTeknica is an ISO 9001:2015 Certified Company
BioTeknica is an ISO 9001:2015 Certified Company BioTeknica has successfully achieved ISO 9001:2015 certification, the highest standards of its kind, for its Quality [...]
Lean Management Systems and the New Normal
Lean Management Systems and the New Normal Miguel E Guerrero, Lean Sensei, Managing Partner, Synergis Corp., a BioTeknica sister company The output of any [...]
FDA Program Alignment & The New CDRH in Bite-Sized Chunks
FDA Program Alignment & The New CDRH in Bite-Sized Chunks Changes at the FDA are impacting life science manufacturers. In 2013 the Agency [...]