21 CFR Part 11 Compliance 2016 - 21 CFR Part 11 Compliance - By Compliance Global Inc

Overview:
This Webinar will explain what 21 CFR Part 11 training is, why it is important to c companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained.
FDA regulation training is required for companies who want to transition to electronic record system for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient.
FDA has set up regulations that address both data security and patient safety. This webinar will show how 21 CFR part 11 considers both. The confusion over the original FDA regulation and its subsequent “selective enforcement” will also be explained.
Why Should You Attend:
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would “selectively enforce” sections of the regulation. This webinar will explain what all this means.
Areas Covered in this Webinar:
Company certification
Records covered
Understanding the importance of audit trails
Open/closed system access rules
Electronic signatures
IT security training requirements
Learning Objectives:
How to establish compliant electronic record system
How to prevent patient safety compromises
Who Will Benefit:
Engineering Personnel
QA Professionals
IT Professionals
Quality Assurance
Management Team
Speaker Profile:
Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices.
His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.
Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.