Docstoc

21 CFR Part 11 Add-On Inspections by the FDA

Document Sample
21 CFR Part 11 Add-On Inspections by the FDA Powered By Docstoc
					 Live Webinar on : 21 CFR Part 11 Add-On Inspections by the FDA
 Tuesday, July 10, 2012 duration    : 10:30 to 12:00 PM EDT




                                               Why should you attend :

                                                In December 2010 FDA started the Part 11
                                               inspection initiative. While originally the initiative was
                                               supposed to last 3-6 months, it has now turned into
                                               an ongoing program with Part 11 related issues
                                               being part of most future inspections.

Get 15 % Discount as a early bird
registrations. Use Promo Key :
                                               At the beginning of the initiative FDA made it very
 CGO15
                                               clear that Part 11 is in effect and is enforced
                                               according to the original Part 11 and the Guidance
                                               from 2003.



                                                In the meantime FDA officials reported about key
                                               findings. For example, George Smith who heads up
                                               FDA's Part 11 working group gave an update with
                                               examples of violations. This webinar will enable you
                                               to determine whether your company is subject to the
                                               most common violations so you can take action to
Pricing                                        have a better inspection outcome..




Live ( Single registration ) : $189.00
Group ( Max 10 Attendee): $249.00
On Demand (Recording available):$289
Get Training CD : $449                        Areas Covered in the Session:
Play back(Unlimited views):-309            
                                              What is FDA's most current thinking related to
                                               computers and electronic records?
Who will benefit: (Titles)        - What are the inspection trends?
                                  - What are most frequent recent citations for
* Everybody using computers in     Part11?
FDA regulated environments        - What are the most frequent deviations for
                                   computer system validation?
* IT manager and staff            - Under which circumstances can inspectors
* QA managers and personnel
                                   exercise enforcement discretion?
* Regulatory affairs
                                  - How important is risk based Part11
* Training departments
* Consultants                      compliance?
                                  - What is the best strategy for future proven Part
* Validation specialists
                                   11 compliance?
                                  .
.

                                   .About Speaker




                                   Angela Bazigos has been accepted into the prestigious
                                   ranks of Stanford Who’s Who as a result of her
                                   remarkable work in the biotechnology industry.
                                   Throughout her brilliant professional career, Angela has
                                   routinely exhibited the passion, vision and dedication
                                   necessary to be successful in the business world.

                                   Angela Bazigos is the CEO of Touchstone Technologies
                                   Silicon Valley, Inc. “Your Passport to Compliance”. She
                                   has 30 years experience in the Life Sciences industry
                                   spanning project management, Quality Assurance and
                                   Regulatory Affairs. She has applied for patents aimed at
                                   speeding up Software Compliance and FDA Audits.

                                   Angela is a member SQA (Society of Quality Assurance) as
                                   well as of the SQA CVIC (Computer Validation Initiative
                                   Committee), DIA and RAPS. She provides consulting
                                   services to Pharma, Biotech, Medical Device and CRO
                                   industries on compliance matters, including strategy,
                                   submissions, quality assurance, computer systems
                                   validation, and remediation’s following action by the
                                   FDA. She also teaches classes on Compliance, 21 CFR 11,
                                   Computer Systems Validation, and Project Management.

                                   More recently, Ms. Bazigos co-authored Computerized
                                   Systems in Clinical Research, Current Data Quality and
                                   Data Integrity Concepts with FDA, DIA and Academia. She
                                   is also on the board for UC Berkeley’s Haas Business
                                   School for Executive Education in Life Sciences.
https://compliance2go.com/index.php?option=com_training&speakerkey=13&productKey=56
                      Compliance2go | www.Compliance2go.com
                      Phone : 877.782.4696 | Fax : 281-971-0286
                        Email : Support@compliance2go.com

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:47
posted:8/1/2012
language:
pages:4