Search Trainings
Qualification of Contract Software Developers based on Practical Experience
This webinar will explain the regulatory requirements and a risk based procedure to qualify and manage suppliers that develop software for your company. The phases of the selection process, from compiling a list of candidate developers through the qualificatio ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Sep 18, 2019
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, tem ...
- Basic & Intermediate
- 60 Mins
- Roger Cowan
- Sep 24, 2019
Adverse Event Reporting and Product Recalls
This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint hand ...
- Intermediate
- 75 Mins
- Joy L. McElroy
- Sep 24, 2019
Implementation and Management of GMP Data Integrity
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hyb ...
- Basic
- 60 Mins
- Danielle Delucy
- Oct 02, 2019
Medical Device Software Verification and Validation
This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.
- Basic & Intermediate
- 60 Mins
- Nancy Knettell
- Oct 04, 2019
CAPA Under U.S. FDA / CGMPs and EU MDR / ISO
CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and one of the four key areas of a medical device QSIT inspection. CAPA is a key source of regulatory problems. The primary areas for CAPA focus. The roles of Failure Investigation ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
- Oct 15, 2019
Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdicti ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Oct 23, 2019
FDA’s New Approach in Regulating Medical Software
As technology continues to advance in all areas of healthcare, the software has become an essential part of virtually all products, integrated widely into digital platforms that serve medical purposes The FDA has recognized its traditional approach to devic ...
- Basic & Intermediate
- 60 Mins
- Dennis Weissman
- Oct 23, 2019
US FDA’s 2019 - 2020 Strategic Priorities
In their latest strategic priority cycle, the FDA has committed to reduce the time and cost required to bring a product to the U.S. market and support it throughout its life cycle while not compromising reasonable assurance of safety and effectiveness. To achi ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
- Oct 30, 2019
EN/IEC 62304 - Is your Medical Device Software Out of Compliance?
This course is essential for Medical Device and IVD companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for ...
- Basic & Intermediate
- 60 Mins
- Nancy Knettell
- Nov 06, 2019