Embed

Excel Spreadsheet

Document Sample

Description

Awareness and ideas can really change the way we work but nevertheless it is also very crucial that these are allowed to bloom and be nurtured keeping in mind the various rules and regulations and other such compliance issues....Compliance2go

Thus Compliance2go staff makes a committed effort to bring the best and the ever changing and important laws available to those who need to be educated on this regard.

We commit to bring you quality webinars from industry experts in a timely fashion. Ensuring your business strategy is on the right track to face the future bounties. The best part of this kind of learning involves that you don't have to spend money for going to any location

Compliance2go as the name suggests that without having proper adherence to the ever changing compliance rules and regulations, of the government any company needs to halt. The undying need for operational transparency ensures that the professionals are well in advance educated and do execute and make their company compliant. This could only be possible with assistance from experts, regulators, compliance professionals, and other such stalwarts of the industry. Nevertheless assistance can be expensive and time consuming.

This is done by hosting cost effective and informative webinars, web alerts and also holding discussion forums where you can discuss on the nature, existence and relevance of various laws. This will also help you to do networking with various professionals and give a new dimension to your business.

We desire and thrive to impart effective trainings to give you the best to fulfil your objective requirement for various compliance issues. Every compliance training is structured, presented and deployed so that you can understand what it means to you and your company.

Shared by: supportc2go

Tags

Stats

views:: 22
posted:: 2/2/2012
language:
pages:: 2

Public Domain

Live Webinar on : Design History File (DHF), Device Master Record (DMR), Device

History Record (DHR) and Technical File (TF) - Regulatory Documents Explained

Wednesday, February 29, 2012

duration : 01:00 to 02:00 PM EST

Description

Many citations by FDA and notified bodies include

Get 15 % Discount as a early bird findings with respect to insufficient information in the

registrations. Use Promo Key : Design History File, not following the procedures to make

CGO15 the device as established in the DMR, and incomplete or

inaccurate production data of incoming,in-process and

finished products. Is your company able to access all

Who will benefit relevant documents detailing the design of your device? Is

your DMR accurate and is it being followed? Can the

operators access your DMR? Are you recording and

 Compliance director documenting all your production and testing data and

 CEO maintaining them in the DHR?

 CFO

 Privacy Officer

 Security Officer

 Information Systems Manager . Areas Covered in the Session:

 HIPAA Officer

 Chief Information Officer

 Health Information Manager

 Healthcare Counsel/lawyer

 Office Manager

 Contracts Manager

Pricing

Live ( Single registration ) : $189.00

Group ( Max 10 Attendee): $249.00 Areas Covered in the Seminar:

1. Requirements for Excel Spreadsheets

2. FDA Part 11 Validation Guidance

3. Compliance Problems with Spreadsheets

More Trainings 4. Design Specifications for 21 CFR 11 compliance

5. How does the FDA Design and Use spreadsheets

6. Documentation for Part 11

7. Future Trends in 21 CFR 11 compliance for Excel

Spreadsheets

About Speaker:

Angela Bazigos is the CEO of Touchstone Technologies

Silicon Valley, Inc. an FDA Compliance company. She has

almost 30 years experience in the Life sciences industry

and has applied for patents aimed at speeding up Software

Compliance. She is a member of the SQA CVIC (Society of

Quality Assurance Computer Validation Initiative

Committee), DIA and RAPS and teaches classes on 21 CFR

11, Computer Systems Validation, Compliance Strategy

and Project Management. More recently, Ms. Bazigos was

selected to co-author Computerized Systems In Clinical

Research / Current Data Quality and Data Integrity

Concepts with FDA, DIA and Academia

https://compliance2go.com/index.php?option=com_training&speakerkey=13&productKey=28

Compliance2go | www.Compliance2go.com

Phone : 877.782.4696 | Fax : 281-971-0286

Email : Support@compliance2go.com