Compliance Key - Compliance Online Training Webinars, Regulatory, Medical Device, FDA, Financia

Compliance Key INC  -  Medical Device Training   Overview This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated 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 regulated companies want to transition to electronic records 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. We will show how 21 CFR part 11 considers both. The confusion over the original FDA regulation and its subsequent "selective enforcement" will be explained Why should you attend this webinar? Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483...

Compliance Key INC  -  Certified Regulatory Compliance                                             Howard Cooper Howard Cooper is a Keynote Speaker at Compliance Key Inc. with over 40 years of experience in Pharmaceutical and Medical Device Quality in startup, small, medium, and large businesses and corporations This experience includes all levels of quality and regulatory affairs.   Webinar Id:   LSHCPHTC001  10:00 AM PT | 01:00 PM ET   01/11/2018  Duration: 60 mins  Overview Senior Management has the responsibility to be involved in design and implementation of the quality system and this responsibility continues to include participation in quality activities. The most productive activity of this continued participation is to ensure that periodic internal audits are conducted ...