FDA's New Enforcement of 21 CFR Part 11

  • Speaker:Ludwig Huber
  • Duration:90Min
  • Product Code:GRC-90220

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
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  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. 
Why should you attend:

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings. The seminar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.

Areas Covered in the Session:

  •     FDA's current inspection and enforcement practices
  •     FDA's new interpretation: learning from FDA inspection reports
  •     Strategy for cost-effective implementation of Part 11: A six step plan
  •     Recommended changes to existing Part 11 programs to reduce costs
  •     Justification and documentation for the FDA and your management
  •    Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for  individual Part 11 requirements with justifications and documentation for the FDA and your management.
  •    Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent re occurrence of the same or similar issues. 
  •    How to prepare your company for Part 11 Inspections

Who will benefit:
  •     IT managers and system administrators
  •     QA managers and personnel
  •     Analysts and lab managers
  •     Validation groups
  •     Software developers
  •     Validation professionals

Instructor Profile :
Ludwig Huber, Ph.D., is the director of Lab compliance and editor of Lab Compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, , ISPE, Japan PDA, PIC/S and several other national health care agencies.

Available Options

Recording: 6 Months Access to the Training which can be accessed from any location

$289

CD-DVD: Shipped within 2 working days

$389

USB - Shipped within 2 working days

$409

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$2,659

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$3,659

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