Compliance Trainings, 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
2015-03-04
Description : This course provides a background to CSV regulations and guidance on the overall process of validation and the importance of good documentation. Computer System Validation is a regulatory requirement under ICH GCP and 21 CFR Part 11 but it also makes good business sense to ensure that computerized systems will perform consistently as expected. Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company’s product. Achieving the validated state requires much more than just User Acceptance Testing. This detailed webinar will explain the basic tenets of of 21 CFR 11 compliance for Computer Systems Validation and will show how to deliver on time and on budget while meeting regulatory compliance requirements in a more effective manner. Areas Covered in the Session : How big is computer system validation? Regulatory background and useful definitions The validation process The importance of documentation User Acceptance Testing (UAT) Maintaining the validated state Who Will Benefit: This webinar is a must for: Regulatory Affairs Staff Data Managers Clinical Affairs Staff Clinical Research Professionals Monitors Programmers Statisticians Any company that uses a computerized system to give input to new systems specifications and/or User Acceptance Testing Price tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Compliance Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com Like Us On FaceBook: https://www.facebook.com/events/1564114313829092/?pnref=story
|