All regulatory Events (49)

2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems at SFO, CA

July 24, 2014 at 9am to July 25, 2014 at 6pm – WILL BE ANNOUNCED SOON The Problem: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 a… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda

FDA Device Software Regulation

July 29, 2014 from 10am to 11am – Online Event Overview: Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. S… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
Best Practices in Supplier Management

July 29, 2014 from 10am to 11am – Online Event Overview: Supplier qualification and assessment is required in both the QSR regulations and ISO standards.Many companies spend a great deal of time and money in pursuit of compliance with this. Many… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda

Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for "Combo" Products

July 30, 2014 from 10am to 11am – Online Event Overview: What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used i… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

July 30, 2014 from 10am to 11am – Online Event Overview: 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 re… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda

2-day In-person Seminar on Global Medical Device Regulation at Denver, CO

July 31, 2014 at 9am to August 1, 2014 at 6pm – WILL BE ANNOUNCED SOON Overview: This course provides an overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements, including both voluntary and mandatory st… Organized by GlobalCompliancePanel | Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda