ComplianceOnline

Good Documentation Practice (GDocP) for FDA Regulated Industry

Instructor: Eleonora Babayants
Product ID: 705782
Training Level: Intermediate
  • 17
  • September 2018
    Monday
  • 07:00 AM PDT | 10:00 AM EDT
    Duration: 90 Min

Live Online Training
September 17, Monday 07:00 AM PDT | 10:00 AM EDT | Duration: 90 Min

$199.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$349.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD/USB

$449.00

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This good documentation practice webinar will discuss connection between CxP/GMP and document control, which documents need to be controlled and which are not, what documentation required for QMS, how QA can plays an important role in documentation systems. It will also discuss how change control procedure should be used in GxP/GMP environment.

Why Should You Attend:

Good Documentation Practice is the systematic procedure of preparation, reviewing, approving, issuing, recording, storing, and archiving documents.

Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product.

In this webinar, we will discuss the connection between GxP/GMP and document control. We will identify controlled documents. We will also describe documents of Quality Management System.

Details of document control procedures and the role of Quality Assurance in the documentation systems will be described. We will also review document management systems, as well as the change control procedure and how it should be used in GxP/GMP environment.

Areas Covered in the Webinar:

  • GxP/GMP and Documentation
  • Purpose of Document Control
  • Controlled Documents – Types, Identification
  • Role of QA in Document Control
  • Document Control Procedures
  • Document Management System
  • Measuring Success of Document Control System
  • Change Control Procedure

Who Will Benefit:

  • Quality Assurance
  • Compliance
  • IT
  • Medical Affairs
  • Documentation Management
  • Document Control
Instructor Profile:
Eleonora Babayants

Eleonora Babayants
Founder and President, Galaxy Consulting

Eleonora Babayants - Founder and President Galaxy Consulting, is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management.

Eleonora's past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs.

She led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users’ requirements. She wrote technical documents and created documents templates.

Eleonora's experience spans multiple industries including biomedical, pharmaceutical, medical devices, food and beverages companies.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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