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, , 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.
Areas Covered in the Session :
Who will benefit :
QC Managers
QA Managers and Personnel
IT Administrators
Analysts
Regulatory Affairs
Training Departments
Documentation department
Consultants
Other topics:
Validation and Control of Excel® Spreadsheets in Regulated Environments
FDA Computer System Validation Steps
Validation of Analytical Methods according to the New FDA Guidance
Instructor Profile :
Ludwig Huber, , is the director of Labcompliance and editor of , 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.
27 Oct 2017 @ 01:00 am
27 Oct 2017 @ 02:30 am
Duration: 1 hours, 30 minutes
English en