2nd Annual Pharmaceutical Quality & Data Integrity Excellence 2017Date: 12th to 14th April 2017, Malaysia
Overview
The world of pharmaceutical development and manufacture is having to change its culture and practice to meet the opening global market. Outsourcing, global sourcing and international inspections are becoming a common occurrence and international pharma companies need to differentiate by having consistent, world-class GXP compliance systems that meet the demands of many stakeholders and inspection authorities.
The demand for consistent Quality Management Systems is becoming a requirement, not an option. Delegates will, therefore learn the core elements of an internationally recognized GMP QMS, know the core legislation elements of key markets and be able to author and implement a fit-for-purpose GMP QMS and compliance system to meet the international market, with the aim of becoming ‘inspection-ready’.
Because the pharmaceutical industry has traditionally focused upon the application of Good Manufacturing Practice (GMP), it has been slow to consider the potential benefits to be gained by implementing an EN ISO 9001Quality Management System (QMS). Over the last few years the global pharmaceutical market has undergone significant change, forcing pharmaceutical companies, more than ever before, to focus on customer needs and upon their own internal efficiency in order to continue to compete effectively
Benefits
- To enable you to implement a world-class GMP QMS in your company that has the potential to be inspection-ready for such as WHO and other foreign inspectorates.
- To enable you to gain senior management commitment to GMP, through simple and effective systems.
- To understand how to influence your management and peers to achieve an effective Quality Culture.
- To be able to describe a simple, effective and inspection ready QMS to your management and colleagues.
- To know current trends in Data Integrity and how to avoid common inspection findings.
- To have a core understanding of key GMP Pharmaceutical Legislation and its impact on your QMS.
Who Should Attend
- Senior Vice Presidents, Vice Presidents, Senior Executives, Heads, Directors and Managers of:
- Quality Management
- Quality Assurance
- Quality Operations
- Quality Control
- Quality Systems
- Regulatory Affairs
- GMP Compliance QbD
- Process Validation
- Quality Supply Chain
- Quality manufacturing oversight
- GMP auditors and inspectors
- Site heads and plant managers R&D Productions
