Your probability of success increases the earlier and more thoroughly you prepare – our proven processes fully prepare your organization for any regulatory challenges.
We’re a consulting firm specializing in regulatory compliance, FDA inspection readiness, quality engineering, and validation projects for the medical device, biological, and pharmaceutical industries.
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.” [...]
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, [...]
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 [...]
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, [...]
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 [...]
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 [...]
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. [...]
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 [...]
BioTeknica Awarded Highest Standards Certification: ISO 9001:2015 BioTeknica has successfully achieved ISO 9001:2015 certification, the highest standards of its kind, for its Quality Management (QM) system. For life science manufacturers, it means BioTeknica has a rigorous QM system and standards in place throughout its operations and that every engineer and team member in our organization is [...]
Ready, Set, Go! Coaching Your Team to Validation Success Device manufacturers often don’t have the time or the internal resources to train their staff. BioTeknica’s Ready Set Go! is a proprietary, interactive, hands-on coaching program where our personnel help you successfully train your team members in developing and executing validation protocols, performing test result analysis, and [...]
