Live webinar By Compliance2go by compliance2go


									 Live Webinar on: 21 CFR Part 11: Audit Trails – Ins and Outs
 Wednesday, June 13, 2012 duration : 12:00 to 01:15 PM EST


                                         21 CFR Part 11 is FDA regulation for electronic
Get 15 % Discount as a early bird        signatures and electronic records. It started by
registrations. Use Promo Key :           the pharma - it is a good regulation for medical
 CGO15                                   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
Live ( Single registration ) : $189.00
Group ( Max 10 Attendee): $249.00        - Q/A session with the Expert
On Demand (Recording available):$289
Get Training CD : $499                   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
Who will benefit                    Description of the topic:

Quality Managers                    Ausir trails are major requirement for many software
Quality auditors                    applications regardless of an industry or users. This is
Small business owners               especially true when it comes for Pharma and medical
                                    devices companies and other businesses that have
CAPA investigators
                                    implemented or are planning on implementing 21 CFR Part
FDA inspectors
                                    11 and striving to comply with the same regulation.
Software engineers and developers

                                    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
More Trainings                      - What if’s?

                                    - Commonly asked questions about Audit Trail

                                    - What is next about 21 CFR Part 11

                                    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.

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