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
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
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
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
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