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Compliance Global Inc
2754 80th Avenue
New Hyde Park, NY 11040
(516) 900-5515

Compliance Global Inc
(516) 900-5515

Event Description

Overview:

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.

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

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.

For more detail please click on this below link:

https://complianceglobal.us/product/700500

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

If the Review Electronic Data and Audit Trails- By Compliance Global Inc. is important to your business, act now and make the appropriate connections. See the contact information below.

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Event Details

Website: https://complianceglobal.us/product/700500...
Conference/Event Dates: 08/17/2016 - 08/17/2016
Conference/Event Hours: 1:30
Classification: B2B
Primary Industry: Medical Technology
Other Industries: Health Information, Medical Coding & Billing, Medical Technology, Professional Healthcare
Cost to Attend: Live Session for one participant Price: $175.00
Audience: Senior Quality Managers
Quality Professionals
Regulatory Professionals
Compliance Professionals
Validation Engineers
Production Engineers
Quality Engineers
Quality Auditors
Document Control Specialists
Show Owner:Compliance Global Inc.
Sponsorship: Yes
Sponsorship Details: Compliance Global Inc

Booth Details

Booth Size Booth Cost   Available Amenities
No Exhibiting   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

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