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58 results of "Manufacturing x"
Live Webinar

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 ...

Live Webinar

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.

Live Webinar

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 ...

Live Webinar

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
  • Oct 08, 2019
Live Webinar

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 ...

Live Webinar

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
Live Webinar

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 ...

Live Webinar

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 ...

Recorded Webinar

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 ...

Recorded Webinar

Dealing with Delayed Responses to Corrective Action Request

If you’ve ever issued a CAR (corrective action request) you know what it’s like. You sort of silently hope (pray?) that the individual to whom you sent it will give it the respect it deserves.Why wouldn’t they, given that it is an indication that there are def ...