2015 - Webinar On Learning from Recent FDA Warning Letters related to Part 11 and Computer Validation

Description :
Some time ago FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 related issues being part of most inspection. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings and inspectors regularly cited deviations related computer to validation and other Part 11 issues. Because of missing clear guidance from the FDA the industry has lots of questions. Using recent warning letters as examples, this seminar will demonstrate how current Part 11 requirements will be met.
For easy implementation, attendees will receive
Checklist: Part 11 compliance
Case Studies: How to avoid Part 11 related 483's and Warning Letters
SOP: Electronic Audit trail: Specifications, Implementation, Validation
Areas Covered in the Session :
FDA inspections: Preparation, conducts, follow up
The meaning of warning letters and 483 inspectional observations
Learning from an FDA presentation: “Data Integrity and Fraud - Another Looming Crisis?”
Data integrity and authenticity: FDA's new focus during inspections
Examples of recent Part 11 related 483’s and Warning Letters
Examples of recent 483’ and warning letters related to computer system validation
Most obvious reasons for deviations
Avoiding and responding to 483: going through case studies
Writing corrective AND preventive action plans as follow up to 483's
Using internal audits to prepare yourself for Part 11 related FDA inspections
Strategies and tools for compliant Part 11 implementation
The future of Part 11and computer system validation
Who Will Benefit:
Everybody using computers in FDA regulated environments
IT managers and staff
Manufacturers of drug substances (APIs)
Medical Device Manufacturers
Analytical Contract laboratories
Clinical contract laboratoriers
QA managers and personnel
Quality control directors or delegates
Regulatory affairs
Training departments
Consultants
Validation specialists
Price tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/Product...