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 receiveChecklist: Part 11 complianceCase Studies: How to avoid Part 11 related 483's and Warning LettersSOP:  Electronic Audit trail: Specifications, Implementation, ValidationAreas Covered in the Session :FDA inspections: Preparation, conducts, follow upThe meaning of warning letters and 483 inspectional observationsLearning from an FDA presentation: “Data Integrity and Fraud - Another Looming Crisis?”Data integrity and authenticity: FDA's new focus during inspectionsExamples of recent Part 11 related 483’s and Warning LettersExamples of recent 483’ and warning letters related to computer system validationMost obvious reasons for deviationsAvoiding and responding to 483: going through case studiesWriting corrective AND preventive action plans as follow up to 483'sUsing internal audits to prepare yourself for Part 11 related FDA inspectionsStrategies and tools for compliant Part 11 implementationThe future of Part 11and computer system validationWho Will Benefit:Everybody using computers in FDA regulated environmentsIT managers and staffManufacturers of drug substances (APIs)Medical Device ManufacturersAnalytical Contract laboratoriesClinical contract laboratoriersQA managers and personnelQuality control directors or delegatesRegulatory affairsTraining departmentsConsultantsValidation specialistsPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458