Data Quality and Integrity Management in GMP Environment

Description:

Data management refers to all  activities performed during data lifecycle including but not limited to data policy, documentation, quality, integrity and security. Good data management practices influence the quality of all data generated and recorded by a manufacturer. These practices should ensure that data is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.

Objectives

This online live workshop will cover data integrity, data quality, paper and electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

Contents

  • Understand the current MHRA, FDA and EU GMP regulations and guidance impacting data integrity from paper records to hybrid and electronic systems
  • Learn what is required for a data governance system from senior management through to staff in laboratories, manufacturing and quality assurance
  • Understand the data life cycle and how it is linked with the business process and where problems can occur for both paper records, hybrid systems and electronic systems
  • Understand the need for Data integrity throughout the system and data life cycles and the requirement for a data governance framework
  • Learn how to implement data quality and integrity framework and governance and policies throughout the organization
  • Learn how to meet  the international regulatory requirements for electronic records and signatures
  • Understand how to maintain Data Integrity through the operation phase of GMP life cycle
  • Know why An Audit Trail and Its Review are Important:
    • Part 11 and Annex 11 / Chapter 4 requirements for audit trail
    • Regulatory requirements for audit trail review
    • Guidance documents for audit trail review
    • Do I really need an audit trail?

Who should attend?

This Live Online Training is designed for managers and staff from health care and clinical study industries as well for auditors who are responsible for the organization and execution of audit trail (reviews) in their companies:

  • All those working in a GxP regulated environment that require a working knowledge of data quality and integrity, electronic records and signatures, and the associated operational aspects of GxP computerized systems
  • Anyone who needs a fundamental understanding of Data Integrity regulation and risk management approaches to achieving electronic record and signature compliance
  • Computer system vendors or consultants, engineering contractors, and validation service companies.
  • Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of Data Quality Governance.

General Information

– Training material and practical examples will be distributed
– An attestation of course completion will be issued to the participants who have attended the training course.

Speaker

Kossi Molley, Chemist, LSSBB, Chartered Trainer – Managing Consultant

  • Date : 01 Dec 2022 - 02 Dec 2022
  • Time : 9:00 am - 4:00 pm (America/Toronto)
  • Reg. Deadline : 28 Nov 2022
  • Venue : Zoom

Purchase Ticket

English Session: Dec 01, 2022
$299.00
$ 0
French Session: Dec 02, 2022
$299.00
$ 0
0.00
$ 0.00
[Note: This event will be held on zoom. Attendee will get zoom meeting URL through email]

Organizers

Mivado GlobalPerformance

Social :

Related Events

English French
Zoom

GACP and GMP for Cannabis products

Description: Good agricultural practices (GACP) and good manufacturing

English Training Session
Zoom

Practical Computerized and Automated System Validation

Two Days Training Session By discussing Patient Risk-based

English French
Zoom

Digital & Computerized System Validation

The V-model has become a standard worldwide methodology

English French
Zoom

Introduction to EU GMP Annex 11

The EU GMP Annex 11 applies to all

French Training Session
Zoom

Gestion de la Qualité du Cannabis

La gestion de qualité au sein des entreprises