How Ensuring Data Integrity in Method Validations

  • Free
  • Published date: December 8, 2017
    • Fremont, California, United States

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 developed, validated and used. Additionally, how to ensure Data Integrity will be discussed. The webinar will focus on detailing all key components of the guidance and analyze its validation parameters, tests, and acceptance criteria with respect to Data Integrity.

Areas Covered in the Session:
Scope and Content of the Guidance
Performing Pre-Validation Studies
Analytical Method Transfer Studies
Data Integrity and Documentation Requirements

Who Will Benefit:
Contract Laboratory Staff
Laboratory Managers and Staff
Analysts
QA Managers and Personnel
Regulatory Affairs Personnel

Speaker Profile:
Gary Miller has over 20 years in the R&D and manufacturing areas in the pharmaceutical industry. Gary’s hands-on experience includes investigations (product and manufacturing), product development, manufacturing, quality, auditing, regulatory, project management, and laboratory management.

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

  • How to Implement MDSAP-Requirements into your ISO 13485

    How to Implement MDSAP-Requirements into your ISO 13485

    Data Management Fremont (California) February 22, 2019 150.00 Dollar US$

    Overview: How a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working. Why should you Attend: Your implementation time sh...

  • Data Integrity: Compliance with 21 CFR Part 11

    Data Integrity: Compliance with 21 CFR Part 11

    Data Management Fremont (California) February 22, 2019 150.00 Dollar US$

    Overview: This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. Areas Covered in the Session: What 21 CFR Part 11 means today Purpose of Part 11 Wha...

  • Understanding and Implementing a Technology Transfer Process

    Understanding and Implementing a Technology Transfer Process

    Data Management Fremont (California) February 22, 2019 150.00 Dollar US$

    Overview: Identify elements of the business process framework for managing technology transfers. Explain benefits of technology transfer. Determine elements of a successful technology transfer. Why should you Attend: This presentation will introduce ...