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 Part 11 inspections, e.g., what inspectors are looking at what are major findings. The seminar will have the answers. In addition, 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. For More Details: Email: david@grcts.com Tel: +1-248-233-2049 Web: www.grcts.com

1. Call Us: +1-248-233-
2049
12/19/2016www.grcts.com1

2. FDA's on-going Part 11 Inspection Program
12/19/2016
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Description :
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
Part 11 inspections, e.g., what inspectors are looking at what are major findings. The seminar
will have the answers. In addition, 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.

3. FDA's on-going Part 11 Inspection Program
12/19/2016www.grcts.com3
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 reoccurrence of the same or similar issues.
 How to prepare your company for Part 11 Inspections

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Who will benefit :
QC Managers
QA Managers and Personnel
IT Administrators
Analysts
Regulatory Affairs
Training Departments
Documentation department
Consultants

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Webinar details:
 Speaker: Ludwig Huber
 Date: 12th January 2017 10:00 AM PST | 01:00 PM EST
 Duration: 75Min
 Product Code: GRC-90078
To register this webinar click here
https://www.grcts.com/GRC-90078

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Speaker Instructor Profile:
Ludwig Huber, Ph.D., is the director of Labcompliance and editor of
www.labcompliance.com, the global online resource for validation and
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. For more information,
please visit Dr.Huber’s website www.ludwig-huber.com

7. FDA's on-going Part 11 Inspection Program
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Speaker: Ludwig Huber
Date: 12th January 2017 10:00 AM PST | 01:00 PM EST
Duration:75Min
Product Code: GRC-90078