Designing, Drafting, Writing, and Implementing The Quality Manual
Overview:
This webinar will begin with a brief discussion about quality then begin to explore how quality manuals have evolved into a communications device that assists all functions to reach their goals and objectives.
It will demonstrate that the quality manual represents system for working together to achieve the organization's goals. You'll be shown that a quality system exceeds compliance requirements without question. As mentioned above, it can be viewed as a "Organizational Constitution" that empowers people to "pass laws" (SOPS) for working together. It establishes a system of checks and balances that result in a system for resolving conflict.
Graphics will be used to the role of the quality manual from the decision to formalize the quality system that includes the steps of design, planning, writing, collaboration-review-approval, training, implementing, maintenance, and ensuring its continuity and effectiveness through internal auditing. Examples of indexes and excerpts from real quality manuals will be used to illustrate the implementation of quality principles.
Throughout the webinar, the importance of Senior Management support through commitment and involvement/participation in the design and management of the quality system will be emphasized.
Why should you attend: I do not know the status of your quality manual or even if you have one. Whatever the case, this webinar will provide insight and a fresh perspective about quality manual expectations. If your organization is currently designing and developing the quality manual, you'll learn about quick improvements that will make your manual more effective. If you already have a quality manual, use the expectations and requirements outlined in the webinar as an "audit checklist" to identify gaps or to congratulate yourself on a job well done.
The attendees receive a PDF handout that will provide supporting materials for designing, developing, implementing, or improving your organization's quality manual. This indexed handout will be in a reference format.
Areas Covered in the Session:
- A Brief Quality Lesson
- Why have a quality manual and should it be manual, hybrid, or electronic?
- Exploring and defining the modern quality manual
- Regulatory requirements and current industry practices for the quality manual.
- Players and Responsibilities-Interdepartmental roles in establishing and maintaining the quality manual.
- The scope of the quality manual can be very broad
- Graphical Overview of the Quality Manual Lifecycle--Planning, Designing, Review and Approval, Training, Implementing, Changing/Improving And Maintaining
- Applying the Quality Manual Lifecycle Starting from Scratch to Final Approval
- Using the manual for internal auditing.
Who Will Benefit:
- Senior Management
- Operations Supervisors and Managers
- Purchasing and Procurement
- Human Resources
- All Levels of Quality Assurance
- Outsourcing contractors the pharmaceutical and medical device industries
- Contract Laboratories
- Suppliers