2 Day In-Person Seminar on Computer Systems Validations, Data Integrity, 21 CFR Part 11 Compliance a
- Start Date:
- Tuesday, 18 April, 2017
- End Date:
- Wednesday, 19 April, 2017 6:30pm
- Internal Medicine, Business Practice, Health & Nutrition
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. There is no doubt that data integrity is the current and future inspection focus of all regulatory health care agencies.
More than 60% inspection reports such as 483's and Warning Letters quote data integrity as deviations from GxP regulations. Only way to control and avoid warning letters is by receiving effective Training. Mr. Kalpesh Vaghela's extensive years of experience in Data Integrity can help your team to better understand & could help reduce your vulnerability of getting 483's and warning letters.This workshop provides the regulatory background and guides attendees through the complete record lifecycle from data evaluation, reporting, archiving and retrieval.
It also helps to fully understand not only the text but also the meaning of related regulations such as FDA's Part 11 and the Annex 11. A central element of this course will be an explanation of the GAMP approach to 21 CFR Part 11 compliance, as well as compliance with other international regulations covering ERES. The GAMP Guide provides timely and much needed direction on meeting current regulatory expectations for compliant ERES.
You will learn how to use risk management to ensure compliance of regulated ERES.The course not only ensures a full understanding of the regulations and guidelines for raw data and other records but also develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations.WHO WILL BENEFITA must attend seminar for professionals in Pharmaceuticals, QC Laboratories, Manufacturers of drug substances (APIs), Finished Products, Contract Laboratories, CROs, Medical Device & Biotech companies, and Suppliers of Computer Systems.DEPARTMENTS:Quality Control & Quality AssuranceResearch and DevelopmentLaboratoryRegulatory ComplianceIT/IS & Software DepartmentsValidationProduction & ManufacturingDocumentationTraining DepartmentsPROFESSIONALS:Managers and SupervisorsSenior Managers and Team LeadersDirectors, VP's, CxO's, General ManagersAnalytical ChemistsValidation SpecialistsLaboratory Managers and SupervisorsRegulatory Affairs ManagersDocumentation Specialists & AnalystsConsultants and Systems Administrators Learning Objectives:Role of FDACSV PointsWhy Validation?Benefits of ValidationGAMP 521 CFR Part 11 ComplianceAnnex 11Data IntegrityRelated Warning Letter PointsCSV DeliverablesBest PracticesRisk Assessment ….and More Pricing:For One Delegate: Rs. 18,000 Rs. 16,000 (Save over 11% from Early Bird Offer)Register for 3 Delegates and 4th person gets a Free Pass (Save Rs. 24,000)Early Bird Offer ends on March 9th, 2017Contact US:Compliance Trainings861, Peripheral Road, Koramangala, Bangalore - 560095 | Ph: +91-(0)80-4170-052+91-(0)80-4170-0521 firstname.lastname@example.org
Bangalore - 560095 | Ph: +91-(0)80-4170-052
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