"Medical Device Compliance Training delivered by leading experts through webinars. This section contains compliance training affecting Medical device industry in areas - MDR, ISO 13485, ISO 14971, GMP,CGMP, Sterilization, Failure Modes and Effects Analysis (FMEA), Submission, Approval, EU / Latin America Regulation, Packaging & Labeling, Microbial, Vendor/Supplier/CRO Compliance, Clinical and Documentation."
This 90-minute webinar on supplier controls will help you refine your supplier management and audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program.
This 90-minute webinar will discuss the requirements and compliance under the applicable FDA regulations for medical device reporting (MDR), recall and reports of corrections and removals in the US. It is designed to help the audience develop, maintain and implement adequate procedures.
Instructor : David Lim LiveWednesday, May 23, 2012
This 90-minute webinar on device corrections and removals will clarify your obligations for corrections and removals under Part 806 of the FDA regulations.
This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software.
Instructor : Dev RahejaLiveWednesday, June 6, 2012
This 90-minute presentation will discuss a structured way to mitigate risks with minimum cost. You will learn how to use FMEA to effectively estimate and assess risks in your medical device.
This 90-minute webinar will discuss the new FDA "Global Engagement" Initiative for new areas for heightened CGMP compliance from U. S. FDA-regulated companies and their global partners. It will cover areas for increased awareness, focus, and remediation, and the approaches that are now mandated.
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
Instructor : Jeff KasoffLiveThursday, June 21, 2012
This 90-minute webinar on sampling plans using ANSI/ASQ Z1.9 will explain the methods in Z1.9 and shows how to use it in a more modern setting (using simple statistical calculators).
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
Alan Calder
Alan Calder is an international authority on IT governance and information security management. He is the author of IT Governance: Guidelines for Directors, and IT Governance Today: a Practitioner's Handbook. He is the founder director of IT Governance Ltd (www.itgovernance.co.uk), and has consulted with a wide range of companies (including Cisco) on how to deploy best-practice frameworks to improve regulatory compliance and reduce compliance-related cost and risk profiles.
