Medical Device Regulations and Guidance Training - Live Webinars, Recordings & CDs

This webinar will provide valuable assistance and guidance to medical device companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.

This IDE (Investigational Device Exemption) webinar will cover its purpose and preparation recommended subject headings and content Submission and follow up Usage in the clinical trial(s).

This class reviews the modular option of filing a PMA and the benefits it offers all companies having to negotiate through the PMA process.

This 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.

This Medical device training will talk about recent developments in the European Commission’s approach towards the parallel distribution of medicines. In the past the European Commission has taken a strong stance against restrictions imposed by pharmaceutical companies on wholesalers and distributors of medicines, preventing them from parallel importing the contract products within the European Union ("EU").

Key insights to the background of the revision for medical device manufacturers with products in Europe. The Medical Devices Directive 93/42/EEC (MDD) is the key European Directive for regulatory compliance and placing of a CE mark on a medical device.

In this Medical device training will provide an explanation of what a New Approach Directive is and what they all have in common from a compliance perspective. The placing of a CE mark on a medical device implies compliance with all European "New Approach" directives that apply and typically three or four directives will have to be considered.

The steps for conducting Method 1 and identifying typical issues that might arise when conducting the test method. This presentation is the first of three presentations on the methodologies for the determiniation of the minimum sterilization dose.

This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.

This webinar will highlight and summarize the main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.

Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing EM programs.

This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.

This training program will provide an outline of the typical protocols used for documentation of qualification activities, the type of information normally included in each and the common deficiencies cited when audited. It will highlight the importance of establishing specifications for all test challenges, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.

This pack of 2 courses contains the essentials of FDA Medical Device regulations.

This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.

This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.

This Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).