Compliance for Computer Systems Regulated by FDA - 2017

  • Free
  • Published date: August 14, 2017
    • Fremont, California, United States

Overview:
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, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

Why should you Attend:
This Webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.

Areas Covered in the Session:
Validation Strategy
System Risk Assessment
GAMP 5 "V" Model
21 CFR Part 11
Electronic Records/Electronic Signatures (ER/ES)
Security, Access, Change Control and Audit Trail

Who Will Benefit:
Clinical Data Managers and Scientists
Analytical Chemists
Laboratory Managers
Automation Analysts
Manufacturing and Supply Chain Managers and Analysts
Computer System Validation Specialists

Speaker Profile:
Carolyn (McKillop) Troiano Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Result 0 votes
Compliance4All
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • Assessing and Planning for Risk (Latest 2018)

    Assessing and Planning for Risk (Latest 2018)

    Chemical Methods Fremont (California) July 11, 2018 150.00 Dollar US$

    Overview: Project risk is greater the longer your project lasts, the longer the time between preparing your project plan and starting the work, the less experience you, your team members, or your organization may have with similar projects, and the n...

  • Design Control is Critical to Product Quality

    Design Control is Critical to Product Quality

    Chemical Methods Fremont (California) June 15, 2018 150.00 Dollar US$

    Overview: This 90-minute webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. Why should you Attend: Design C...

  • CART Toxicity and Safety

    CART Toxicity and Safety

    Chemical Methods (New York ) May 22, 2018 Check with publisher

    To maximize CAR-T cell potency and minimize side effect, toxicity management is crucial for CAR-T cell therapy during cancer treatment. Creative Animodel will assist you in assay development and data analysis to advance the process of your therapy in...