Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Training Overview
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Inadvertent use of out-of-date documents or not approved documents can have significant negative consequences on quality, costs, customer satisfaction, and can even cause death.
Why Should you attend
In the regulated industries which must be GxP/GMP compliant, document control is the cornerstone of the quality 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.
Learn how to manage and control documents in compliance with GxP/GMP requirements and be able to pass quality audit.
Learn how to secure, manage and govern your documentation in compliance with GxP/GMP requirements and be able to pass quality audit
Only controlled documents should be used to perform work. But not all documents need to be controlled.
In this webinar, describe 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.
Webinar Takeaway
- 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
Learning Objectives
In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.
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.
Auditors pay particular attention to documentation to make sure that it complies with GMP and GDocP. Therefore, in order for an organization to meet GxP/GMP requirements, it must have a document control system in place.
Learn how to manage and control documents in compliance with GxP/GMP requirements and be able to pass quality audit.
Can't Make this LIVE Webinar?
Simply select the Recorded option when registering and we will send you the link to view the recorded version.
Who will Benefit
- Quality Assurance
- Documentation Managers
- Records Managers
- Document Control
- Compliance
- Medical Affairs
- IT