openPR Logo
Press release

Current FDA Trends in Inspection and Enforcement Related to Regulated Computer Systems

11-23-2018 03:01 PM CET | Health & Medicine

Press release from: Edupliance

Current FDA Trends in Inspection and Enforcement Related

Edupliance announces webinar titled, “Current FDA Trends in Inspection and Enforcement Related to Regulated Computer Systems” The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. The event goes LIVE on Tuesday, December 04, from 01:00 PM to 02:30 PM, EST / 10 AM to 11:30 AM PST.

In this webinar join expert speaker Carolyn Troiano, where she will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.

The 90-minute webinar will be conducted by Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).

Webinar attendees will learn:

•The most proactive methods for getting ahead of the curve and avoiding computer system validation pitfalls
•Understand Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
•Learn how to document CSV efforts related to “GxP” systems – Good Manufacturing, Laboratory and Clinical Practices (GMPs, GLPs, GCPs)
•Learn about 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES) Documentation
•Understand Data Archival to ensure security, integrity and compliance
•Understand how to effectively document the process of computer system validation, and maintain current information about the systems in your organization and how they are maintained in a validated state

Edupliance is an online information provider which offers webinars (Live and On-Demand), DVD’s and downloadable resources that cover concurrent topics pertaining to various industries. With an expert panel of guest speakers, Edupliance brings state-of-the-art virtual technology solutions and industry-leading training sessions that are easy to learn, easily accessible and cater to people with varied interests. Edupliance is privately held and located in Hillsboro, Oregon.

For more information, visit www.edupliance.com.

Media Inquiries

support@edupliance.com

T: 1 – 844-810-1151
A:- Edupliance - #101, 4660, NE Belknap Court, Hillsboro, OR 97124 |

This release was published on openPR.

Permanent link to this press release:

Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.

You can edit or delete your press release Current FDA Trends in Inspection and Enforcement Related to Regulated Computer Systems here

News-ID: 1395674 • Views: 1124

More Releases from Edupliance

New York State Law: - Drafting the Policy and Complaint Procedures
Edupliance announces webinar titled, “New York State Law: - Drafting the Policy and Complaint Procedures” In this webinar Speaker will discuss the examples of unlawful sexual harassment and also includes the information about concerning the federal and state statutory provisions concerning sexual harassment and remedies available to targets of sexual harassment. The event goes LIVE on Thursday, December 20, from 01:00 PM to 02:00 PM, EST / 10 AM to
Employee Overpayment & Taxation
Edupliance announces webinar titled, “Employee Overpayment & Taxation” Review of different types of overpayments from regular pay to non-cash items such as laptops given to employees. The event goes LIVE on Friday, December 14, from 12:00 PM to 01:00 PM, EST / 09 AM to 10:00 AM PST. Join Dayna Reum, for this information-packed webinar and know better ways of handling overpayments in all scenarios, to keep companies out of
How to Handle Everyday Multi-Family Management Issues
Edupliance announces webinar titled, “How to Handle Everyday Multi-Family Management Issues” In this webinar attendees will know how to effectively handle unauthorized residents and resident violations, including damages found during inspections. The event goes LIVE on Wednesday, December 05, from 01:00 PM to 02:00 PM, EST / 10 AM to 11:00 AM PST. In this webinar join expert speaker Paul Flogstad, where he will discuss some of the most common
The Importance of Employee Handbooks and Compliance with the National Labor Rela …
Edupliance announces webinar titled, “The Importance of Employee Handbooks and Compliance with the National Labor Relations Act” This webinar will provide the audience with the tools they need to develop legally a compliant Employee Handbook. The event goes LIVE on Thursday, November 29, from 01:00 PM to 02:00 PM, EST / 10 AM to 11:00 AM PST. In this webinar join expert speaker Jennifer Komsky, where she will explain the

All 5 Releases


More Releases for FDA

Austrianova files Drug Master File with FDA
S.E. Asian company, Austrianova, headquartered in Singapore, announced today that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA). This DMF provides all confidential and detailed information covering the production of Cell-in-a-Box® encapsulated cell products based on encapsulated HEK293 cells and derivatives. This includes CypCaps™, the encapsulated cell product that its’ partner and client PharmaCyte Biotech Inc., is about to use in
FDA Compliant Blood Storage and Preservation
Accsense Monitoring System Automates Data Archive and Alarming CAS DataLoggers provided the temperature alarming and monitoring system to a hospital blood bank looking to replace their old paper chart recorders as they became unreliable and spare parts were harder to find. For proper blood storage and preservation, the lab’s medical units needed to maintain storage temperatures between 2°C to 6°C (36°F to 43°F), given the perishability of blood components. The facility
fda online training
GRC Training Solutions provides end-to-end FDA compliance solutions for those companies who want to maximize security, minimize operational costs, improve staff productivity and stay on top of all their compliance documentation. GRC Training Solutions boasts a team of experts and specialists who have a proven track record in working with the biotechnology, medical device, diagnostic and pharmaceutical fields. Our team will work with you closely and develop solutions that meet
US FDA Prohibits 19 Antibacterial Soap Ingredients
The US Food and Drug Administration (FDA) has issued a final rule regarding 19 ingredients in over-the-counter (OTC) consumer antiseptic products intended for use with water. The FDA has now determined that these 19 ingredients are not generally recognized as safe and effective (GRAS/GRAE) and so, without an approved new drug application, products containing these ingredients are now considered misbranded – effective September 6, 2017. The US FDA issued its final
11-09-2016 | Science & Education
GRCTS
FDA online training
Description: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. Initially, FDA issued a 28-page Proposed Rule that would amend its regulations regarding
MetaFix™ PlantarMAX™ Foot Plate received FDA-Release
Merete Medical GmbH announces the FDA-approval for MetaFix™ PlantarMAX™ plate. PlantarMAX™ is designed as the first plantar/medial Lapidus fixation plate which takes advantage of the biomechanically superior fixation on the tension side of the Metatarsal/Cuneiform joint during a Lapidus Hallux Valgus correction procedure. The fixation on the tension side of the joint is superior to dorsal or medial fixation and offers additional compression as the patient proceeds to weight bearing. Merete