Behavourial GMP/Good Documentation Practices/Data Integrity (12 – 14 March 2018) – 3 day Course
|Dari Isnin, 12 Mac 2018 - 8:00 |
Ke Rabu, 14 Mac 2018 - 5:00
Aim: To provide an introduction on the concepts of behavioural GMP and how they relate to human errors and incidents as well as develop methodologies for root cause analysis and failure investigation. This course helps quality managers and supervisors understand and identify personnel’s mentality and common behaviours and cultural changes to minimise human errors.
Day 1 Behavioural GMP
AM/PM ► Knowledge and Understanding GMP concepts, compliance and improvement
►Discipline Skills – sources of human error and strategies to reduce human error in manufacturing
Day 2 Good Documentation Practices
To understand the importance of creating documents and the need to maintain records in the industry to ensure compliance as well as traceability for processes and to prevent error. To understand the need for Good Documentation Practices to be applied throughout the manufacturing and supply chain.
AM/PM ► Reasons and requirements for GMP documents and records
►Importance of document controls
►Current requirements for electronic records and signatories
►Handling of product complaints, recalls and CAPA
Day 3 Data Integrity
Data Integrity has become widely discussed as a global concern for the pharmaceutical industry. This section provides an introduction to develop a broad understanding of the scope of Data Integrity and how key principles may be applied in order to provide strategic elements necessary to ensure reliability and integrity of information and data throughout all aspects of a product’s lifecycle.
AM/PM ► The definition of Data Integrity within a Quality Management System
►Regulatory framework for Data Integrity and Document Control Practices
►Behavioural GMP and development of a quality culture to enable Data Integrity compliance