Validation and Compliance for FDA and Other Agencies

Time 2020-06-14 17:04:35

Web Name: Validation and Compliance for FDA and Other Agencies

WebSite: http://www.labcompliance.com

ID:1105

Keywords:

Compliance,and,Validation,

Description:

FDA Compliant IT Infrastructure and Network QualificationWith Strategies and Tool Kit for Compliance and System UptimeRecorded, available at any time Ensuring Data Integrity for FDA/EU ComplianceComply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid recordsRecorded, available at any time Understanding the new Revision of USP 1058 With examples and procedures for effective implementationRecorded, available at any time Understanding the New FDA Guidance for Validation of Analytical MethodsWith 10+ best practice guides for easy implementationRecorded, available at any time Learning from Recent Warning Letters related to Part 11 and Computer ValidationWith Clear Recommendations for Corrective and Preventive ActionsRecorded, available at any time Transfer of Analytical Methods According to New FDA, USP and EU-GMP GuidelinesWith SOPs, templates and examples for easy implementation Recorded, available at any time Validation and Use of Cloud Computing in FDA Regulated Environments Comply with GXPs, Part 11, EU Annex 11 and other regulationsRecorded, available at any timeUnderstanding the New FDA Data Integrity GuidanceWith examples and procedures for effective implementationJune 22, 2017 Contingency and Disaster Recovery Planning for Computer Systems To Ensure Business Continuity and ComplianceJune 26, 2017 Integrity of Laboratory Data for FDA/EU complianceUnderstand and implement data integrity through the entire data life cycleRecorded, available at any time with all reference material FDA s New Enforcement of Part 11 Learn what the FDA is looking for and how to respond Recorded, available at any time Qualification of Virtual Networks and Cloud Computing With Strategies and Tool Kit for Compliance and System Uptime Recorded, available at any time Managing Electronic Raw Data in Regulated Environments Definition, generation, evaluation and archiving for FDA, PIC/S and EU compliance Recorded, available at any time FDA/EU Compliant Handling of OOX Test ResultsLearn how to investigate out-of-trend (OOT) and out-of-expectation (OOE) vs. OOS resultsRecorded, available at any time Managing Out of Trend Results in Pharmaceutical Quality Control With Strategies and best Practice Guides for easy Implementation Recorded, available at any time Validation and Control of Excel Spreadsheets for FDA Compliance Understand requirements and get tool kits for easy implementation Recorded, available at any time Validation of Analytical Methods according to the New FDA GuidanceUnderstanding FDA s New Lifecycle Approach Towards Method ValidationRecorded, available at any time Transfer of Analytical Methods According to the New USP Chapter 1224 With SOPs, templates and examples for easy implementation Recorded, available on demand System Suitability Testing for FDA and USP Compliance Setting parameters and limits for chromatographic and other methods Recorded, available on demandAnalytical Equipment Qualification and System Validation for FDA ComplianceCombining the USP 1058 with the new GAMP(TM) Laboratory Computer Systems GuideRecorded, available on demandFDA Compliant Use of (Certified) Reference MaterialStrategies for selection, purchasing, testing and documentationRecorded, available on demand How to Prepare Yourself for FDA s on-going Part 11 Inspection Program Learn what the FDA is looking for and how to respond RecordedNew release with 46 SOPsCD for training and tools for easy implementationWith master plans, 31 SOPs, Checklists, Examples, Audio seminarComply with FDA s Current InterpretationReference book for Part 11 ImplementationFor FDA/EU Compliance of Excel SpreadsheetsWith seminar presentations, primer, SOPs, checklists and exampleswww.fdawarningletter.com300 GxP related FDAEIR s/483 s and Warning Letters Ten New Class-Room Trainings with Dr. Ludwig Huber in Boston, Zurich, San Francisco, Mumbai, and Singapore All courses are interactive and include group exercises for easy learning All courses come with 20+ course related best practice guides on dedicated seminar websites for easy implementation For qualifications of Ludwig Huber, click here For communications with the US FDA and other agencies, click here January 2016

TAGS:Compliance and Validation 

<<< Thank you for your visit >>>

Hot Websites