Search Trainings

254 results of "Life Sciences x" and "Medical Devices x"
Live Webinar

21 CFR Part 11 (Electronic Records and Signatures) Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, ...

Live Webinar

Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ

This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol ...

Live Webinar

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation This highly interactive training uses life examples and explores proven techniques for reducing costs, usually by two-thirds, as ...

Live Webinar

ETHICS: BEST PRACTICES AND DECISION MAKING

This webcast is intended to discuss with professionals the importance of ethics in all our business relationships and in the performance of our duties.  We will look at what “ethics” is and discuss processes, procedures, and controls we can use to maintain our ...

Live Webinar

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.  Medical device manufacturing plants, required to follow 21 CFR ...

  • Basic & Intermediate
  • 60 Mins
  • José Mora
  • Jul 21, 2020
Live Webinar

Implementing a Robust Data Integrity Program

Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle.  Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on the topic during co ...

Live Webinar

Content and Format of an Initial IND submission 21 CFR 312.23

This webinar is designed to help pharma companies through the content and format of every module of the common technical document for an initial IND. The presentation will cover the in depth understanding of the contents of every module in the CTD.

Live Webinar

European Union Device Regulation (EU MDR)

The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The ...

Live Webinar

Project Management Tools for Regulatory Compliance

This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time. It w ...

Live Webinar

Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.  Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdicti ...