Search Trainings
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
Understanding Initial IND Submission- The first 30 days
This webinar will shed light on the entire process that takes place from the time the sponsor submits the initial IND to the FDA for initial 30-days. Alongside this presentation would detail the various grounds on which the FDA may consider placing a clinical ...
- Basic & Intermediate
- 60 Mins
- Gowri Sukumar
- Oct 22, 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
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the r ...
- Intermediate
- 90 Mins
- Joy L. McElroy
- Nov 06, 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
GMPs for Medicinal Cannabis Growers and Processors
The medical marijuana industry is in its infancy in the United States. A large number of individual states have legalized medical marijuana to varying levels of control and regulation. Medical marijuana is illegal on a US Federal level but all predictions are ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
- Nov 08, 2019
The Use Of Statistical Process Control (SPC) Using Control Charts To Maintain Compliance In The Laboratory
Statistics can be used to monitor critical variable in the running of a procedure and in the performance of the instrumentation that performs it. By applying Nelson’s rules this data can be evaluated as performing as expected or performing in ways that are sta ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Nov 13, 2019
Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)
Outline of the relevance of information from the CMC perspective Understanding differences between small molecules and Biologics Glimpse of CFR 312.22 with the highlight on the FDA’s primary objectives in reviewing an IND Overview of Pre-IND activities C ...
- Basic & Intermediate
- 60 Mins
- Gowri Sukumar
- Nov 19, 2019