Overview: FDA's different Part 11 rules takes quite some time, but inspectors go out and also examine portable computers and e-records regarding complying by using GMPs as well as newest Part11 interpretations.
Just in 2007/2009, there has been regarding 30 Warning Letters linked for you to Part 11 compliance, many with disastrous outcomes regarding inspected companies. It feels that will 'enforcement discretion' as explained inside the 2003 direction seriously isn't applied every more. FDA's computer skilled John Murray proposed with a conference for you to follow 21 CFR Part 820 likewise pertaining to meds organizations but community wants a lot more guidance in addition to simple tips about how to answer FDA's new enforcement practice.
Areas Covered within the Session:
* FDA's present-day examination along with enforcement methods * FDA's new interpretation: mastering from FDA guidance, plus latest FDA meeting reports along with negotiations * Learning out of FDA inspection reports * Part 11 as well as different EU Annex 11: similarity in addition to distinctions * Strategy to get cost-effective implementation involving your 'new' Part 11:A six step plan * Recommended adjustments that will existing Part 11 products to lessen prices * Justification along with records for that FDA and your administration * 12-15 Case experiments out of laboratories, practices in addition to producing together with graphical workflow of records, step-by-step description, recommendations with regard to personal Part 11 demands together with justifications along with certification for the FDA along with your management. * How to organize for Part 11 Inspections
Who Will Benefit:
* IT managers as well as System Administrators * QA Managers and Personnel * Analysts in addition to Lab Managers * Validation Groups * Software Developers * Validation Professionals * Training Departments * Documentation Department * Consultants
Overview: FDA's innovative Part 11 regulation takes a relatively good time, but inspectors move out and also look personal computers and also e-records with regard to complying using GMPs and most recent Part11 interpretations.
Just within 2007/2009, there are regarding 30 Warning Letters in connection with Part eleven compliance, many having terrible implications for inspected companies. It looks like of which 'enforcement discretion' because expressed around the 2003 support just isn't employed virtually any more. FDA's personal computer qualified John Murray recommended in a management meeting to be able to abide by 21 years of age CFR Part 820 likewise for drug companies nevertheless industry requirements extra instruction plus sensible recommendations with the right way to respond to FDA's new enforcement practice.
Areas Covered within the Session:
* FDA's present-day examination plus enforcement practices * FDA's new interpretation: finding out out of FDA guidance, plus current FDA convention presentations along with chats * Learning from FDA examination stories * Part eleven plus the fresh EU Annex 11: similarity and also disparities * Strategy with regard to cost-effective guidelines of the 'new' Part 11:A five step strategy * Recommended modifications to existing Part eleven applications for you to lessen fees * Justification plus certification for any FDA your direction * 15 Case research from laboratories, practices plus manufacturing along with graphical workflow of records, step-by-step description, referrals regarding person Part 11 requirements having justifications and certification for your FDA your management. * How to prepare for Part 11 Inspections
Who Will Benefit:
* IT supervisors and also System Administrators * QA Managers along with Personnel * Analysts and Lab Managers * Validation Groups * Software Developers * Validation Professionals * Training Departments * Documentation Department * Consultants
Price List:Live : $245.00Corporate live : $995.00Recorded : $295.00
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