Training Doyens

Tom Kramer President and CEO of Kablooe Design Years of Experience:  26+ years Areas of Expertise:  Product Development in Medical Device Industry Tom Kramer , president and CEO of Kablooe Design, has been a product innovator for over 26 years, and holds a Certificate in Master of Product Development from North-western University and a Bachelor’s in Industrial Design degree from MCAD. He also holds a certificate from Stanford University in Cardiovascular System in Health and Disease. He creates revenue for his customers by delivering innovative product solutions to their portfolios. Mr. KraMer spearheaded the  D3 Process™ (Design Driven Development) , a vehicle to provide these results to customers, and he teaches this process by travelling as a lecturer and speaking about innovation, creativity, and development processes.

Edwin Waldbusser Edwin Waldbusser Regulatory consultant Years of Experience:  30+ years Areas of Expertise:  Design Control, Risk Analysis and Software Validation of Medical Devices Edwin Waldbusser  is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 9 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA.  He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

David R. Dills David R. Dills Global Regulatory Affairs & Compliance Consultant Years of Experience:  26+ years Areas of Expertise:  Regulatory Affairs, Compliance and Quality Systems David R. Dills , Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers enga...

OVERVIEW FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how  FDA 21 CFR Part 11  compliance checklist considers both. The confusion over the original FDA regulation and its subsequent  “selective enforcement ” will be explained. FDA requirements for electronic record and signature validation will be explained. The requirements are composed of technical and procedural aspects. Open, closed and hybrid (paper and electronic) systems will be explained. WHY SHOULD YOU ATTEND Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA origina...

OVERVIEW This webinar will explain how to determine if your mobile apps are medical devices and if they will be subject to FDA requirements. The FDA approval process for mobile medical apps will be explained including FDA software validation requirements which are more extensive than just testing performance. Cybersecurity is very important for mobile apps. The FDA cybersecurity requirements in the app design will also be explained. FDA cybersecurity requirements WHY SHOULD YOU ATTEND The FDA has released a Guidance explaining how they intend to apply their regulatory authority to software applications intended for use on mobile platforms. They have defined what types of mobile apps they consider a medical device. Apps that are medical devices must meet all FDA software validation requirements and FDA cybersecurity requirements, however, FDA will not enforce their requirements on mobile apps that meet the FDA’s definition of a medical device but pose a low health ri...

OVERVIEW FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both. The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained. FDA requirements for 21 CFR Part 11 validation will be explained. The requirements are composed of technical and procedural aspects. Open, Closed and  H ybrid  (paper and electronic) systems will be explained. WHY SHOULD YOU ATTEND Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part ...