Conference Description:

Course "Governance and Change Control According to GxP/GMP Requirements " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:
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.
Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure.
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.
With all systems in place, change management and user adoption become necessary.
In this seminar, you will learn the framework of GxP/GMP regulations, information governance procedures as well change control procedure and how to implement them.
You will also learn how to implement data security, e-discovery and crisis preparedness as well as change management and user adoption strategies.

Why should you attend:
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.
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.

Who will benefit:
• Quality Assurance
• Documentation Managers
• Records Managers
• Document Control
• Compliance
• Medical Affairs
• IT

Agenda:
Day 1 Schedule

Lecture 1 (90 Mins):
GxP/GMP Framework
• GxP/GMP, its Role, and its Consequences for the Regulated Industries

Lecture 2 (90 Mins):
Information Governance
• What is Information Governance?
• Information Governance Procedures
• Information Governance Implementation
• Information Governance in Document Management Systems
• Social Media Management and Information Governance

Lecture 3 (90 Mins):
Change Control Procedure
• GxP/GMP and Change Control Procedure
• Change Control Procedure Steps
• Change Control Procedure for Document Control

Lecture 4 (90 Mins):
Change Control Procedure for Information Technology (IT) Systems
• IT Change Control Procedure Steps


Day 2 Schedule

Lecture 1 (90 Mins):
Data Security
• Data Security Implementation

Lecture 2 (90 Mins):
E-Discovery
• What is E-Discovery?
• E-Discovery Preparedness

Lecture 3 (90 Mins):
Crisis Management
• What is Crisis Management?
• Crisis Management Preparedness

Lecture 4 (90 Mins):
Change Management and User Adoption
• Change Management Strategy