Live webcast on 21 CFR Part 11: Audit Trails – Ins and Outs By Compliance2go June 13, 2012

DESCRIPTION

21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries. Audit Trails play major role in Part 11 compliance - they can be your best friends and/or worst enemies at the same time.

Attendees will also receive the below Free documents:

- 30+ frequently asked questions (free document) and 21 CFR Part 11 Regulation

- PDF Print only copy of PowerPoint slides shared by the speaker.

- Q/A session with the Expert

Why should you Attend

Increase understanding of the Part 11 regulations; improve compliance and meeting the regulations when it comes to different types of audit trails.

Description of the topic:

Ausir trails are major requirement for many software applications regardless of an industry or users. This is especially true when it comes for Pharma and medical devices companies and other businesses that have implemented or are planning on implementing 21 CFR Part 11 and striving to comply with the same regulation.

Areas Covered in the Session:

- Subsection of Part 11 and Interpretation of the subsection

- Types of audit trails and Strategies of implementing compliant audit trails

- Audit Trail Pros and Cons

- Audit Trail As an Auditing Tool

- Audit Trail Should and Shouldn’t

- What if’s?

- Commonly asked questions about Audit Trail

- What is next about 21 CFR Part 11
Who will benefit:
Quality Managers
Quality auditors
Small business owners
CAPA investigators
FDA inspectors
Software engineers and developers
Consultants

About Speaker

Jasmin NUHIC serves a major medical devices OEM as a Sr. Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn.