GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics.

Documentation is a critical tool for ensuring GxP/GMP compliance. In order to maintain documentation in GxP/GMP compliant manner, information governance should be developed and implemented.

Data security is the high priority in any organization but especially in a regulated industry.

E-Discovery preparedness makes it imperative for organizations to develop an enterprise wide strategy to manage the volume of electronic information. The discovery process affects many individuals in an organization, not just lawyers and others involved in discovery, but also IT professionals and records managers who have to be prepared to produce electronic content for discovery and litigation.

Crisis preparedness is the high priority in any organization but especially in a regulated industry. In this webinar, you will learn the framework of GxP/GMP regulations, information governance procedures and how to implement them. You will also learn how to implement data security, e-discovery and crisis preparedness.

Course 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.

In order to maintain documentation in GxP/GMP compliant manner, information governance procedures should be developed and implemented. In the regulated industries, manufactures are required to use a change control procedure.

It is imperative to secure data, prepare for e-discovery, and be ready if crisis strikes. Learn how to manage and govern documents as well as IT systems in compliance with GxP/GMP requirements and be able to pass quality audit. Know how to secure your data, prepare for e-discovery and crisis.

Why Should You Attend:

When all procedures and systems are set up, change management and user adoption become necessary. Do you know how to properly manage and govern your documentation so that your organization is GxP/GMP compliant? Learn how to manage and govern documents as well as IT systems in compliance with GxP/GMP requirements and be able to pass quality audit.

Is your organization ready for e-discovery and do you have crisis preparedness in place? Do you have change management and user adoption strategy? Learn how to secure your date, prepare for e-discovery and crisis, and how to develop and implement change management and user adoption strategy.

Course Outline:

• What is Information Governance?
• Information Governance Procedures
• Information Governance Implementation
• Information Governance in Document Management Systems
• Social Media Management and Information Governance
• Training and program reviews
• GxP/GMP and Change Control Procedure
• Change Control Procedure Steps
• Change Control Procedure for Document Control

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Assurance
• Documentation Managers
• Records Managers
• Document Control
• Compliance
• Medical Affairs
• IT Professionals