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

  • Recombinant HBV S Protein (Subtype adr)

    Recombinant HBV S Protein (Subtype adr)

    Chemical Methods Shirley (New York) May 30, 2019 10.00 Dollar US$

    Hepatitis B virus (HBV) is a double stranded DNA virus, a species of the genus Orthohepadnavirus, and a member of the Hepadnaviridae family of viruses. The genome of this species consists of a double-stranded circular DNA possessing 3.2 Kb. In additi...

  • Dietary Supplements CGMPS - 21 CFR 111 Compliance

    Dietary Supplements CGMPS - 21 CFR 111 Compliance

    Chemical Methods Fremont (California) May 23, 2019 150.00 Dollar US$

    Overview: Attend this 90 minutes presentation to gain a fundamental understanding of FDA's regulation of Dietary Supplements, Dietary supplements are regulated products, also Dietary supplement marketing, manufacturing, labeling, and advertising are ...

  • Recombinant HPV-16 Protein (aa 1-531)

    Recombinant HPV-16 Protein (aa 1-531)

    Chemical Methods Shirley (New York) April 28, 2019 10.00 Dollar US$

    HPVs are non-enveloped, double-stranded DNA viruses, which are tropic for mucosal tissues. The genome consists of three functionally divided regions: (a) a noncoding regulatory region; (b) an early proteins region, which encodes for six early protein...