Date: | November 28, 2017 - 1:00pm - 2:30pm |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | 26468 E Walker Dr, Aurora, CO, 80016-6104, United States, 26468 E Walker Dr |
Website for Event: | http://bit.ly/2zqQWgS |
Topic: | Health Education |
Description: | OVERVIEW FDA requires that all documentation related to GxP (GMP, GLC, and GCP) products be created and maintained in accordance with specific rules. From the color of the ink used to the retention requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation. WHY SHOULD YOU ATTEND You should attend this webinar if you are responsible for any FDA-regulated data and/or records. All documents need to be created and maintained in accordance with FDA guidelines for good documentation to avoid any issues during an inspection or audit. You will also benefit from learning about the guidelines for computer system validation and the many deliverable documents that need to be produced in a way that is FDA-compliant. Having completed this course, you will be on your way to successful future FDA audits and inspections. AREAS COVERED FDA Good Documentation Practices Information Technology Analysts Pharmaceutical To understand how to create, revise and maintain documentation that is FDA-regulated. During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution. Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations. For more details click on this link: |
Contact Name: | Training Doyens |
Contact Email: | support@trainingdoyens.com |
Contact Phone: | +1-720-996-1616 |