INTRODUCTION TO 21 CFR eleven??? Historical past of 21 CFR eleven??? Current Standing of 21 CFR eleven??? 21 CFR eleven Overview??? 21 CFR eleven.10 (a)-(okay)??? 21 CFR 11.30??? 21 CFR 11.50??? 21 CFR eleven.70??? 21 CFR eleven.a hundred??? 21 CFR 11.200??? 21 CFR 11.300??? The FDA’s Necessities for 21 CFR 11??? FDA’s Add-On Inspections for 21 CFR 1121 CFR eleven.10 (A) COMPUTER TECHNIQUES VALIDATION DELIVERABLES??? Danger Assessment??? Vendor Audit??? Validation Plan??? Necessities Specification??? Design Specification21 CFR eleven.10 (A) LAPTOP TECHNIQUES VALIDATION DELIVERABLES??? Installation Qualification (IQ)??? Operational Qualification (OQ)??? Efficiency Qualification (PQ)??? Traceability Matrix??? Validation Summary Report??? Validation Registry??? SOPs??? 21 CFR 11 Audit21 CFR 11.10 (A) COMPUTER TECHNIQUES VALIDATION DELIVERABLES EXERCISE??? Create ALL Deliverables for a Laboratory Data Management System (LIMS)??? Jeopardy – Test Your Knowledge
In an effort to tackle compliance points, firms must first make themselves aware of the implications of non-compliance. Together with managing enterprise operations, firms typically face the problems of managing documents related to company governance, risk and compliance. Managing these documents could be tiresome, thereby affecting the management and to some extent, the profitability of an organization. Most companies now have a streamlined administration system, due to credentialing providers.
He has more than 35 years of palms on business experience in directing the implementation, validation and obtaining “fit for use” certification of enormous biopharmaceutical manufacturing automation and IT methods. These systems conform to regulatory requirements akin to CFR 21 Part eleven and Annex 11. He has a very broad expertise in facilitating QRM periods for big US firms and has supplied them with guide oversight to ascertain their High quality Risk Management plans.
* Co-operation with regulatory authorities* Compliance with OHSAS regulations in all areas of operations* Compliance with native or corporate ohsas 18001 requirements whichever are essentially the most stringent* Compliance with the principles set down by the industry association or the ICC Enterprise Charter for Sustainable
Areas Covered within the Session:The “actual” story behind some common water system design and control mythsBiofilm properties, resistances, susceptibilities and examplesWater system sanitization to control biofilmWater system microbial enumeration issuesUSP’s view on sampling and microbial enumerationMicrobial enumeration choices/benefits/disadvantagesHow to selected the perfect microbial enumeration method and “validate” itWater System Validation and Change ControlImproving outcomes and lowering the frequency of excursion investigationsHow to carry out profitable Water System excursion investigations and troubleshooting, with case examine examplesWhat USP actually says about all thisCourse Modules & Content Details: