FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
There are many questions about the ongoing inspection and enforcement program, e.g., what inspectors are looking at, what are major findings and what are the FDA expectations about follow up.
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.
Why should you Attend: There are many questions about the P11 inspection program, e.g., what inspectors are looking at and what major findings are. 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.
Failing Part 11 and data integrity inspections can have a high negative impact on regulated companies, on individual employees and most important on the health and safety of the consumers of products such as drugs and medical devices.
publications of FDA Warning Letters will have a negative impact on the company's impact
shipment stops resulting in loss of revenues and profit
requirements for extensive corrective and preventive actions
requirement for hiring 3rd party consultant
While the Part 11 regulation is spelled out very clearly and is well understood by regulated companies, FDA inspections are not. Regulations such as Part 11 and GMPs set forth minimum requirements to assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding safety, identity, strength, quality, and purity. Frequently inspectors ask more because regulations are subject to inspector's interpretations and somewhat unpredictable and sometimes come as a surprise.
The seminar will come with and discuss more than 20 typical inspectional observations and give recommendations on how to avoid observations. And most important: Attendees will have the unique opportunity to ask life questions to the Part 11 and Data Integrity expert during and at the end of the seminar.
Areas Covered in the Session:
FDA's past inspection and enforcement practices
Reason for changing inspections and enforcement
FDA's new interpretation: learning from FDA inspection reports
How can the new requirements be implemented in your company
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 and Data Integrity Inspections
The importance of the quality management system (QMS) and global corporate for Part 11 and data integrity
Questions and answers
Sharing best practices
Who Will Benefit:
IT Managers and System Administrators
QA Managers and Personnel
IT and GMP Consultants
Personnel from Pharma, Biotech and Medical Device Industries
Ludwig Huber Ph.D., is the director and editor of Labcompliance 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, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world.