Course Overview:
This webinar examines the history, rationale, purpose, and GMP requirements applicable to the manufacturing, packaging and labeling, testing, and control of pharmaceutical products and consequence of inaction.
Gain practical knowledge in understanding of the essential elements and quality systems required for GMP and for maintaining compliance in the pharmaceutical industry.
Course Outline:
- Assuring Quality in the workplace
- The benefits of GMP compliance
- Management Responsibilities for GMP
- SISPQ/principles of drug production
- Principles of GMP
- Training/Effective Training Requirements
- GMP Documents
- Standard Operating Objectives
- Quality Control/Quality Assurance
- Methods and Specifications
- Sanitation Programs
- Out of Specification and Deviation Investigations
- Production Controls
- Good Documentation Practice
- Record Keeping
- Validation and their types
- Effective Change Control
- Industry Trends
- Hosting Inspectors and Auditors
Who Should Attend:
This course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:
- Regulatory Affairs
- Clinical Research
- Quality Assurance
- Documentation and Technical Writing
- Product Submission
- Project Management
- Training
- Product Development
- Consultants
- Others who interact together to launch a product
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