Compliance Trainings, Canada
2015-05-07
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@compliancetrainings.com
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