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
How to Select and Use the Right Performance Metrics
Selecting the right metrics requires understanding key stakeholder expectations and how they can be measured, as well as making sure that measures are properly aligned to the hierarchy of objectives. This means that a random or shotgun approach to metrics iden ...
- Basic & Intermediate
- 60 Mins
- Duke Okes
- Oct 17, 2019
SOPs for Commercialization
This webinar will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within th ...
- Intermediate
- 90 Mins
- Peggy J.Berry
- Oct 23, 2019
Cold Chain Best Practices and the Food Safety Modernization Act
The Food Safety Modernization Act (FSMA) is the biggest regulatory overhaul in the history of the U.S. Food and Drug Administration (FDA). The FSMA is a paradigm shift that moves the focus from food inspections to preventative measures and process compliance. ...
- Basic & Intermediate
- 60 Mins
- Joe Lynch
- Nov 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
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
Early Warning Signs of Construction Claims & Dispute
It is axiomatic that claims and disputes on a project do not simply appear out of nowhere. Experience indicates that when a dispute occurs, there is normally a back story or history of events, decisions, lack of decisions, etc. that can be traced back from a ...
- Basic & Intermediate
- 90 Mins
- James G. Zack
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
Why Unfair Contracts Lead to Failure and Essential Negotiation Strategies
Poorly written contracts cost projects up to 20% in increased costs and lead to claims. What are the most important clauses that you should prioritize in negotiations to set a foundation for success, and which clauses to avoid? Learn how you can spot contract ...
- Intermediate
- 90 Mins
- Brian Perlberg
HIPAA Gap Analysis, Risk Assessment and Risk Analysis - Finding and Managing Risks to Protected Health Information
This training on HIPAA compliance will teach the attendees how to examine their security policies, practices, and risk issues to find and fill any gaps in the documentation that is required by the HIPAA rules to show compliance, survive audits, and avoid enfor ...
- Basic & Intermediate
- 90 Mins
- Brian G. Rosenb