AUDIT TRAILS, COMPLIANCE REQUIREMENTS FOR REGULATE 2016 - Review Electronic Data and Audit Trails - By Compliance Global Inc

Website https://complianceglobal.us/product/700500/JoyMcElroy/review-electronic-data-and-audit-trails/1 | Edit Freely

Category Education; E-Learning

Deadline: August 17, 2016 | Date: August 17, 2016

Venue/Country: online webinar, U.S.A

Updated: 2016-07-19 16:28:09 (GMT+9)

Call For Papers - CFP

The purpose of an Audit Trail for Electronic Record systems is to provide assurance of the integrity of the Electronic Health Records and the associated Raw Data.

Although the FDA has stated that it intends to exercise enforcement discretion in relation to audit trail requirements in the 21 CFR Part 11 Guidance to Industry (2003) there have been a number of observations relating to the integrity of records and data since 2003 (see CSV FDA Warning Letters). These have been cited against 21 CFR 211.68.

From the FDA Warning Letters relating to audit trails, it can be seen that it an audit trail is a regulatory expectation where data is stored and has the facility to be changed (modified or deleted). The audit trail requirements impact both computer controlled automated systems and laboratory systems used within the pharmaceutical manufacturing process.

Why Should You Attend:

This 90-minute webinar discusses the compliance requirements for regulated companies in relation to electronic medical record system, electronic patient record integrity and the use of Audit Trails for computer systems.

Areas Covered in this Webinar:

Audit Trails

Compliance requirements for regulated companies

Regulatory requirements (FDA, MNHA/EU Annex 11)

Assuring record Integrity

Systems with Audit Trails

Systems without Audit Trails

Content of an Audit Trail

Learning Objectives:

Learn what audit trails are and how they are established

Learn compliance requirements for regulated companies

Learn regulatory requirements (FDA, MNHA/EU Annex 11)

Learn how to assure record Integrity

Learn the benefits of systems with audit trails

Learn the how systems without Audit Trails may be incompliant

Who Will Benefit:

Senior Quality Managers

Quality Professionals

Regulatory Professionals

Compliance Professionals

Validation Engineers

Production Engineers

Quality Engineers

Quality Auditors

Document Control Specialists

For more information, please visit : https://complianceglobal.us/product/700500/JoyMcElroy/review-electronic-data-and-audit-trails/1

Email: supportcomplianceglobal.us

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515

Level:

Intermediate

Speaker Profile:

Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab.

In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.