JAPM with the support of IFC Announces the opening of Registration for a Virtual Workshop:
“Continuous Improvement and the Quality System”
The PIC/s GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART I refers to ‘Continuous Improvement’ as an integral part of a Quality Management System. It states that “Product realization is achieved by designing, planning, implementing, maintaining and continuously improving a system that allows the consistent delivery of products with appropriate quality attributes”.
This course is designed to provide an overview of the origin of the concept of continuous improvement as it relates to a Quality System and how the concept has evolved over the years. It covers insight into how continuous improvement is integrated into a Pharmaceutical Quality System (PQS) using e.g. Change Management and Risk Management, and how auditors and inspectors can investigate if a company has effectively implemented this for both products and the PQS.
Upon completion of this training course, participants will:
Understand the origin and purpose of the concept of continuous Improvement in the Pharmaceutical Industry.
Explain what Continuous Improvement is in relation to a pharmaceutical product and a Quality System
Identify the PIC/S clauses and Annexes that refer to Continuous Improvement
Understand the differences between jurisdictions
Integrate Continuous Improvement into a Quality Management System
Know what auditors/inspectors will ask in relation to Continuous Improvement
Determine the type of objective evidence that may be produced to meet requirements
Deep dive into regulatory warning letters directly relating to deficiencies in implementing Continuous Improvement into the Quality Management System.
Who should attend this workshop:
Quality Managers and Authorized Person(s)
Quality Control Managers
GMP Team Leaders
R&D Team Leaders
@ Pharmaceutical Companies