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Webinar On Risk Based Validation of Computer Systems and Part 11 Compliance

Start Date:
Wednesday, 4 May, 2016
End Date:
Wednesday, 4 May, 2016 2:00pm
Internal Medicine, Critical Care, Business Practice

Description :FDA and other agencies require to "Base software and computer validation and other controls of electronic records on a justified and documented risk assessment". For example the PIC/S Guide on using computers states: "For GxP regulated applications it is essential to carry out a properly documented risk analysis.The inspector will consider the potential risks as identified and documented by the regulated user to assess the fitness for purpose of the particular system(s)".

Risk based compliance is great because when implemented right it helps to reduce overall validation and compliance costs by focusing resources on high risk systems and save costs on low risk systems. Frequently risk categories are easy to define but the challenge comes when users should define suitable actions for each category.For easy implementation, attendees will receive2 SOPsRisk-based Validation of Computer SystemsRisk assessment Used for GxP EnvironmentsRisk Management Primer: 71 pagesRisk Management in the (Bio)Pharmaceutical and Device IndustryAreas Covered in the Session :FDA/EU and business requirements for risk assessmentGuidance from regulatory and industry task forces: ISO, ICH, GHTF, NIST, GAMP/ISPE, PIC/SPractical approaches for risk assessments of computers and electronic recordsGoing through a practical exercise: Relative risk ranking of regulated recordsDeveloping a risk based software and computer validation programDeveloping a risk based Part 11 compliance programPlanning and implementing for risk based specifications, vendor assessment, installation, testing, change control, back-up, and contingency planningRisk assessment for network infrastructureImplementing risk based security, audit trail, back-up, archiving and retrieval of electronic recordsDocumenting the decision for management and the FDAPractical examples and specific recommendations from laboratories, office computers and productionWho Will Benefit:A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories, Clinical testing laboratories.

The teams that will benefit the most are:QA DepartmentsQC DepartmentsIT DepartmentsAnalysts and lab ManagersRegulatory Affairs DepartmentsTraining DepartmentsDocumentation Departments Consultants


5939 Candlebrook Ct,
ON L5V 2V5,

Organizer Details

Conference organized by Compliance Trainings

This new 2-day Seminar on Computer Systems Validation will explore proven techniques for reducing costs associated with implementing, using, & maintaining computer systems in regulated environments. The FDA performs GxP & Part 11 inspections, with an updated Annex 11 regulation, & companies must update their systems and processes to maintain compliance.

861, Peripheral Road, Koramangala, Bangalore

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