Search Trainings
NFPA 70E Arc Flash Training - HRCI & SHRM Accredited
This webinar training will define what an arc flash is and discuss how to prevent it from occurring. It will offer participants an understanding of the regulatory requirements of the NFPA 70E standard and detail how it applies to your facility. Participants wi ...
- Basic & Intermediate
- 60 Mins
- Joe Keenan
- Jan 30, 2020
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 ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Feb 05, 2020
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
- Feb 11, 2020
Process Failure Mode Effects Analysis: the Newest Approach
Failure mode effects analysis (FMEA) play s an important role in advanced quality planning (AQP) or, in the automotive industry, advanced product quality planning (APQP). It is a structured and disciplined approach for planning quality into a product design (D ...
- Intermediate
- 90 Mins
- William A. Levi
- Feb 20, 2020
Risk Management - Principles of Lean Documents and Lean Configuration
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. During all phases of a project, any new consid ...
- Basic & Intermediate
- 90 Mins
- José Mora
New AIA A201 and ConsensusDocs Standard Construction Contracts
Standard construction contracts set the rulebook for project Success or failure on a project.Contract terms increase the price of project by 20% or more according to some studies. Case law, technology, delivery methods, processes, and insurance have changed dr ...
- Intermediate
- 60 Mins
- Brian Perlberg
Essential Contract Clauses and Approaches for Success
Poorly written and unfair construction contracts lead to risk contingencies of up to 20%. Studies demonstrate that fair, best practice contracts achieve superior results and decrease the risk of claims and litigation.What clauses should you prioritize in negot ...
- Intermediate
- 60 Mins
- Brian Perlberg
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
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
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