Good Documentation Practice (GDocP) for FDA Regulated Industry

Instructor: Eleonora Babayants
Product ID: 705782
Training Level: Intermediate
  • Duration: 90 Min
This good documentation practice webinar will discuss how to secure, manage and govern your documentation in compliance with GxP/GMP requirements and be able to pass quality audit. Also attendees will learn the 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 and how change control procedure used in GxP/GMP environment.

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Aug-2019

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

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Read Frequently Asked Questions

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.

Topic Background:

Good Documentation Practice (GDocP) are the standards in the regulated industries by which documents are created and maintained. Because GDocP is aligned with GxP/GMP, documentation is a critical tool for ensuring GxP/GMP compliance.Inadvertent use of out-of-date documents or not approved documents can have significant negative consequences on quality, costs, customer satisfaction, and can even cause death. Only controlled documents should be used to perform work. But not all documents need to be controlled.

In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the Quality Management System. Auditors pay particular attention to documentation to make sure that it complies with GMP and GDP. Documentation is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down. Therefore, in order for an organization to meet GxP/GMP requirements, it must have a document control system in place.

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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.

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