Date: | July 9, 2020 - 10:00am - 11:00am |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | Online event, Fremont, CA, 94539, United States, Online event |
Website for Event: | https://www.compliance4all.com/webinar/-503191LIVE?selfgrowth-seo |
Topic: | Business Networking |
Description: | Overview: Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance 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. FDA requirements for 21CFR Part 11 validation will be explained. the requirements are composed of technical and procedural aspects. open, closed and hybrid (paper and electronic) systems will be explained. Why you should 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. A 21CFR checklist and a Test protocol form will be given as handouts . Areas Covered in the Session: Origin of the regulation and changes in Interpretation Who Will Benefit: Speaker Profile https://www.compliance4all.com/webinar/-503191LIVE?selfgrowth-seo |
Contact Name: | Compliance4all |
Contact Email: | support@compliance4All.com |
Contact Phone: | 8004479407 |