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12/19/2016

FDA's on-going Part 11 Inspection Program

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.

www.grcts.
com

12/19/2016

FDA's on-going Part 11 Inspection Program

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

Justification

Going

changes to existing Part 11 programs to reduce costs

and documentation for the FDA and your management

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

www.grcts.com

12/19/2016

FDA's on-going Part 11 Inspection Program

Who will benefit :

QC Managers
QA Managers and Personnel
IT Administrators
Analysts
Regulatory Affairs
Training Departments
Documentation department
Consultants

www.grcts.c
om

12/19/2016

FDA's on-going Part 11 Inspection Program

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

www.grcts.co
m

12/19/2016

FDA's on-going Part 11 Inspection Program

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.Hubers website www.ludwig-huber.com
6

www.grcts.c
om

12/19/2016

FDA's on-going Part 11 Inspection Program

Speaker: Ludwig Huber

Date: 12th January 2017 10:00 AM PST | 01:00 PM EST
Duration:75Min
Product Code: GRC-90078

www.grcts.c
om

12/19/2016