JAPM with the support of JFDA & IFC Announces the opening of Registration for the Virtual Workshop: 

Data Integrity Workshop

Data Integrity Training Course

Data integrity is not new. It is implicit, and always has been, as a foundation of good manufacturing practice (GMP).  The subject of data integrity, however, has an increased profile because hybrid (paper and electronic), digital technologies and electronic systems have become prevalent in modern manufacturing.  Globally regulators are recruiting and training their Regulatory Compliance Inspectors in data integrity.  During GMP compliance audits, Inspectors are identifying increasing numbers of GMP violations linked to data integrity.

The course is designed to provide an overview of the latest concepts and guidance documents for Data Integrity including the FDA Data Integrity and Compliance with cGMP Guidance for Industry, released in April 2016, and regulations in PIC/S GMP and 21 CFR 11 and 211.  This course offers a practical insight into data integrity, what it is and how you can develop systems to help protect your employees and organisations form deliberate and unintentional data integrity compliance issues.

Learning Objectives: 

Upon completion of this data Integrity training course you will understand;

• What is data integrity and why is it important
• PIC/S clauses that refer to the integrity of data
• Recap of the ALCOA+ principles
• Relationship between good documentation practices and data integrity
• Security including user access, privileges, audit trails, archiving and retrieval
• Embedding data integrity into your quality systems
• Deep dive into FDA warning letters and case studies so you can practically apply theory to real life.

Who should take this Data Integrity training course?

• Quality Managers and Authorised Person(s)
• Operations Managers
• GMP Team Leaders/Department Heads
• Suppliers and approved vendors (supply chain personnel, contractors, logistics personnel)
• Data Management Personnel
• Internet Technology Personnel and Security System Administrators
• System Administrators, particularly IT personnel and system admin teams in GMP environments and/or laboratories
• Auditors and Self-inspection/CAPA investigators
• Department Heads
• Warehouse managers and distribution personnel
• Logistics Managers and shipping/receiving personnel
• Laboratory researchers and non-clinical personnel
• Clinical research study sponsors

Speaker:

Trevor Schoerie.

Bio:

• Trevor consultants to international regulatory bodies and is a frequent presenter on PIC/S and ISO 13485 standards.

• Trevor is leading GMP trainer in PharmOut’s, the largest GMP consultancy in Asia Pacific with over 2,000 clients.

• Trevor has consulted and audited many companies for US FDA, EU, TGA, PIC/S, medical device, and other local regulatory authority compliance requirements. Trevor has worked closely with a number in international regulatory agencies to obtain PIC/S membership.
• Extensive GMP and pharmaceutical industry knowledge; well recognized as an industry expert (PIC/S, ISO 13485, TGA, FDA, EU, GAMP, WHO).

For registration & more information please email: dana@japm.com

Limited Seats, Stay Distant, Stay Safe!