"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 medical device quality assurance practices will review robust quality assurance principles and teach you techniques and lean methods to help you implement FDA Quality System Requirements.
This Project Management training for FDA Regulated Companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.
This 90-minute webinar will help you understand the 510K process including some history about 510ks versus PMAs and give you the necessary information to know when to file a 510k, as opposed to a PMA, or to not file any 510K of a new or existing medical device.
This 3-hr virtual seminar will discuss the requirements and compliance in medical device adverse event reporting and medical device surveillance/vigilance system in the US, Europe and Canada. It is designed to help the audience with their global compliance in adverse event reporting and surveillance/vigilance system during pre- and post-marketing.
This 90-minute webinar on Advanced Methods of Root Causes Analysis, for medical device companies, will cover principles and methods of Root Cause Analysis (RCA) and review proven techniques for ISO 14971 Risk Reduction based on RCA.
Instructor : Dev RahejaLiveThursday, March 1, 2012
This sterilization validation process training webinar will review the FDA or ISO requirements for tests following validation and emphasis is placed on the appropriate tests for validation, the appropriate routine tests and the frequency of testing.
Instructor : Gerry O DellLiveThursday, March 1, 2012
This 90-minute training will discuss the FDA's QSR requirements for a Device Master Record (DMR) and how you can use it to build your Device History Record (DHR). You will learn what to keep in each record and organize them to help you lower cost in the QMS and provide valuable information when you need to investigate a problem and take corrective action.
Instructor : Daniel O LearyLiveWednesday, February 29, 2012
This webinar will cover the basics of design controls for medical devices, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well.
Instructor : Jeff KasoffLiveThursday, February 23, 2012
This webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs -- their commonalities and their differences.
Instructor : John E LincolnLiveTuesday, February 21, 2012
This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback, and how to include complaint trending into your firm’s CAPA program.
Instructor : Jeff KasoffLiveThursday, February 16, 2012
Dan Swanson
Dan Swanson CMA, CIA, CISA, CISSP, CAP President and CEO, Dan Swanson & Associates is a 24-year internal audit veteran, who most recently was director of professional practices at the Institute of Internal Auditors. Prior to the IIA, Swanson was an independent management consultant for over 10 years.
