Search Trainings
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
- Jul 18, 2019
FDA’s Evolving Approach to Medical Software Regulation
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
- Jul 23, 2019
Secrets to Writing Effective SOPs
Almost every paragraph of the Quality System Regulation says that manufacturers shall “establish” procedures.This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective.You will learn techniques for creati ...
- Basic & Intermediate
- 90 Mins
- Susanne Manz
- Jul 24, 2019
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
- Jul 24, 2019
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Life science manufacturing plants have the additional responsibi ...
- Intermediate
- 60 Mins
- José Mora
- Jul 24, 2019
Understanding the EU Medical Device Regulation
The official texts of the new Medical Device Regulation and the new InVitro Diagnostic Regulation have been released. The current MDR stands at 350 pages and is a complex array of regulations written in the normal legalese. There are many changes that anyone d ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
- Jul 29, 2019
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
- Aug 01, 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 & Advanced
- 90 Mins
- Nancy Knettell
- Aug 02, 2019
Current Trends in Cyber security Threats for Medical Devices
This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could res ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Aug 06, 2019
Manufacturing Quality Agreements- Qualifying Suppliers & Managing Quality in FDA-Regulated Industries
After attending the 75 minute webinar, you will be able to: Identify FDA regulations and new guidance regarding quality agreements Utilize tips to help you manage quality agreements effectively Review the pitfalls to avoid when developing your program Or ...
- Basic & Intermediate
- 75 Mins
- Joy L. McElroy
- Aug 15, 2019