Search Trainings
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
Compliance for Risk Based Approaches for clinical trials including the New FDA RBM Guidance 2019
Risk management is becoming increasingly important for running clinical trials. There are now numerous pharmaceutical guidelines covering risk assessment and management and Risk-Based Monitoring (RBM) including the revised ICH GCP R2 guideline, EU Clinical Tri ...
- Basic & Intermediate
- 60 Mins
- Laura Brown
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented w ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
Medical Device Complaints & CAPA
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing. Post closing effectiveness evaluation is required and will be explained. Preventative Action is often neglected and will be disc ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
Practical Implementation of Pharmaceutical Quality Risk Management (QRM)
Recognize the purpose and value of Quality Risk Management (QRM), as well as how it applies to your job Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions Identify key QRM terminolog ...
- Basic & Intermediate
- 60 Mins
- Steven Laurenz
Post marketing responsibilities for pharmacovigilance in the European Union (EU)
There is comprehensive regulation around the safety of medicines in the EU and marketing authorization holders have extensive responsibilities in this area for the drugs they market. The presentation will provide information on the requirements for pharmacov ...
- Intermediate
- 90 Mins
- Janet Jepras
Effective Batch Record Review
In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of ...
- Intermediate
- 60 Mins
- Danielle Delucy
Cannabinoids as Drugs
This webinar will discuss the current status of cannabinoids as medical products in the United States. The focus will be on what we can learn from the FDA approval of Epidolex (Cannabidiol) oral solution 100 mg/mL. How to obtain research information will be pr ...
- Basic & Intermediate
- 90 Mins
- Loren Gelber
Technical Writing: A Detailed Process
Provides step-by-step instructions to produce excellent written presentations Learn how to balance between being precise enough to cover the subject matter yet general enough to apply to other locations and/or projects Learn how to deal with reviewers and ...
- Basic & Intermediate
- 60 Mins
- Robert Peoples