Search Trainings
Advertising and Promotional material compliance and review process
The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, stra ...
- Basic & Intermediate
- 90 Mins
- Peggy J.Berry
- Aug 21, 2019
Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ
This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol ...
- Basic & Intermediate
- 90 Mins
- Susanne Manz
- Aug 28, 2019
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation - The Requirements
This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements currently being phased out and the new EU MDR Technica ...
- Intermediate
- 90 Mins
- John E. Lincoln
- Sep 10, 2019
How to Properly Investigate OOS Results
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and ...
- Basic & Intermediate
- 60 Mins
- Danielle Delucy
- Sep 10, 2019
How to Implement an Effective Human Error Reduction Program
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. For example; The CFR - Code of Federal Regulations Title 21 Subpart B_Organizat ...
- Basic & Advanced
- 90 Mins
- Ginette Collazo
- Sep 12, 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
- 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
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
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