Good Documentation Practices to Support FDA Computer System Validation Webinar Seminar training classes conferences & workshops presented by Compliance Global register for training on FindaSeminar.com

Home

Add your seminars

Training Calendar Creator Seminar Venues Training Provider Directory
 

New Seminar Search:  

 

Helpful links

find similar training...
Search by state...
Customer Support


Do you need help finding the right class, date, or location or other assistance?

Request information about upcoming training seminars workshops and conferences in   and other cities listed on FindaSeminar.com Submit a support request and receive a prompt reply.

We guarantee this Compliance Global training seminar

We are an authorized partner of Compliance Global

 

Price protection. The price to attend Good Documentation Practices to Support FDA Computer System Validation Webinar is set by the training providerThere is no added charge for our services.

We honor most training provider coupons
*.   Call  a representative to see if your discount coupon applies.


Privacy. Your personal information won't be shared with anyone but the training provider Compliance Global.


Security. When you register for this seminar on FindaSeminar.com your personal data and payment information is safely collected and processed using secure SSL encryption technology.

Flexibility. FindaSeminar.com offers you three ways to register for Good Documentation Practices to Support FDA Computer System Validation Webinar seminar by Compliance Global.
Register online, by phone (800) 349-1935,or fax (800) 712-5569
Who should attend Good Documentation Practices to Support FDA Computer System Validation Webinar
Information Technology Analysts, QC/QA Managers and Analysts, Clinical Data Managers and Scientists, Analytical Chemists, Compliance Managers, Lab Managers, Automation Analysts, Computer System Validation Specialists, GMP Training Specialists, Business Stakeholders Consultants in the Life Sciences Industry
Reviews
Write and read Compliance Global reviews and reviews about the training seminar Good Documentation Practices to Support FDA Computer System Validation Webinar on the Seminar News Network and the Training News Network.
 

Frequently asked questions and registration options for the training seminar Good Documentation Practices to Support FDA Computer System Validation Webinar

 
Find Training Near You
Use our clickable map to find training near you
Use Our Clickmap
 
hotel seminars meeting space directory
hotel meeting space training facilities restaurant and lodging

 
 
 

request on site training details for the Good Documentation Practices to Support FDA Computer System Validation Webinar seminarRequest on site training

Good Documentation Practices to Support FDA Computer System Validation Webinar  

 Email information about this seminar Good Documentation Practices to Support FDA Computer System Validation Webinar by Compliance Global to yourself your manager or associatesEmail this event... View and register for other training seminars like Good Documentation Practices to Support FDA Computer System Validation Webinar by Compliance Global on FindaSeminar.com See similar training.. Find and register for other training seminars by Compliance Global on FindaSeminar.com Other seminars from Compliance Global

By:

training seminars by Compliance Global Compliance Global   

For:

Information Technology Analysts, QC/QA Managers and Analysts, Clinical Data Managers and Scientists, Analytical Chemists, Compliance Managers, Lab Managers, Automation Analysts, Computer System Validation Specialists, GMP Training Specialists, Business Stakeholders Consultants in the Life Sciences Industry

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

Overview : Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data. (see full course description)

 
 
 

 Seminar / Training class dates & locations

 

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search


 

 
 

print the agenda print agenda for the Good Documentation Practices to Support FDA Computer System Validation Webinar seminar

 

Training Course Syllabus:


Good Documentation Practices to Support FDA Computer System Validation

Overview :

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This webinar on computer system validation regulated by FDA, describes the basic requirements for validating and documenting ER/ES capability in systems.

Why Should You Attend :

You should attend this webinar training on computer system validation regulated by FDA, if you are responsible for planning, executing or managing the validation of a system. This is true whether using a "wet" or ink-based signature, or an electronic signature. It is also true whether maintaining paper-based or electronic records. Different requirements pertain to each type of signature or record, and there is a specific set of best practices that need to be followed for either type.

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that the cost of building and managing a computer system validation program will be minimized.

Areas Covered in this Webinar :

Learn the requirements for documenting efforts related to systems governed by FDA
Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
Review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable
Learn how to prepare a procedure that will capture the best practices for FDA compliant documentation
Discuss the importance of training as it relates to good documentation practices to ensure FDA compliance

Learning Objectives :

Get an understanding of computer system validation planning, execution and management concepts, in terms of how these efforts are to be adequately documented to meet FDA requirements
Understand the steps required for documenting the validation process, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs
Get a good grasp of how to leverage these practices across all systems by creating a standardized program

Who Will Benefit :

Information Technology Analysts
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Compliance Managers
Lab Managers
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders
Consultants in the Life Sciences Industry

Speaker Profile :

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

Seminar Summary:

Overview : Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data. (see full course description)

print this agenda print agenda for the Good Documentation Practices to Support FDA Computer System Validation Webinar training seminar

 view dates and locations for this seminar

 

 
 
 Compliance Global training and seminar course catalog

Click any title to view upcoming Compliance Global training event dates and locations, class syllabus and other seminar details

 

     
 

 
     

 

  Also try the advanced seminar search tool

   FindaSeminar HomeComputer Training

unix training
training classes

 © 2002-2018 FindaSeminar.com™ All Rights Reserved.  Terms of Use |  Privacy Policy |  Training News Network