Search Trainings
Good Documentation Practices (GDPs) for FDA-Regulated Computer Systems
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s C ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Jun 19, 2019
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
- Jun 19, 2019
Device Changes and the 510(k) – Hardware and Software
This webinar will evaluate two recently published U.S. FDA Guidance Documents on device changes: 1) “Deciding When to Submit a 510(k) for a Change to an Existing Device Final Guidance for Industry and FDA Staff”; and 2) “Deciding When to Submit a 510(k) for a ...
- Intermediate
- 90 Mins
- John E. Lincoln
- Jun 19, 2019
Avoiding Death by CAPA – What you need to know
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. ...
- Basic & Advanced
- 90 Mins
- Susanne Manz
- Jun 20, 2019
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
- Jun 25, 2019
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
- Jun 27, 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
- Jun 27, 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
- Jul 09, 2019
FDA Internal Complaint Handling
The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages.The webinar will address aspects of the review process, SOP p ...
- Intermediate
- 90 Mins
- Peggy J.Berry
- Jul 09, 2019
Effective Standard Operating Procedure (SOPs) Development
Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system.
- Basic & Intermediate
- 60 Mins
- Danielle Delucy
- Jul 10, 2019