A quality infrastructure within a pharmaceutical company is important to ensure that that the organization complies with global regulations. A solid quality system is central to this framework, and ensures that your final product is safe and effective for use by patients.
To achieve this goal, an all embracing quality program within your company should include technical and managerial activities. Some of the internal documents critical to a quality infrastructure include Standard Operating Procedures (SOPs), an organizational chart, policies, records, and forms. At the heart of this effort is a well written Quality Manual, which summarizes the general protocols governing your company’s Quality Management System (QMS). This document defines your firm’s commitment to managing your operations and activities in accordance with the framework established by ISO 9000 and other quality standards.
This course will enable you to have and understanding of how to construct a Quality Manual while avoiding common pitfalls and ensuring regulatory compliance.
This interactive 90-minute webinar will cover the following salient areas:
- Scope of a Quality Manual
- Internal and external documents
- Quality policy
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis, and improvement