Search Trainings
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
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
- Nov 20, 2019
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
- Dec 11, 2019
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
- Dec 18, 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
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
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
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
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
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