Which data and systems are subject to 21 CFR Part 11

  • Free
  • Published date: April 19, 2018
    • Fremont, California, United States

Overview:
This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.

Areas Covered in the Session:
Ensure data integrity, security, and protect intellectual property
Understand the current computer system industry standards for security, data transfer, and audit trails
Electronic signatures, digital pens, and biometric signatures
SOPs required for the IT infrastructure
Product features to look for when purchasing COTS software

Who Will Benefit:
Quality Assurance
Quality Control
Laboratory Staff
Managers
GMP, GCP, GLP Professionals

Speaker Profile:
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.

Event Fee: One Dial-in One Attendee Price: US$150.00

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

  • Investigator Reporting Responsibilities - OHRP

    Investigator Reporting Responsibilities - OHRP

    Data Management Fremont (California) March 21, 2018 150.00 Dollar US$

    Overview: The webinar will also discuss how to make determinations of whether an adverse event is probably related, possibly related, or possibly/probably not related to a drug or device. Why should you Attend: Are you being cited for failure to repo...

  • C-TPAT - Trade Partnership Against Terrorism 2018

    C-TPAT - Trade Partnership Against Terrorism 2018

    Data Management Fremont (California) March 21, 2018 150.00 Dollar US$

    Overview: The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP). It is intended to improve the security of supply chains of private enterprises against th...

  • How Ensuring Data Integrity in Method Validations

    How Ensuring Data Integrity in Method Validations

    Data Management Fremont (California) December 8, 2017 Free

    Overview: The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements to ensure Data Integrity. Why should you Attend: The guidance changes how FDA regulated methods will be dev...