Sale Date Ended
The two day workshop is designed to provide an in-depth understanding of the concept of pharmaceutical validations based on the current FDA, EU and ICH guidance documents as well as learnings from the pharmaceutical industry. Special emphasis will be laid on practical approach and simple illustrative examples from the industry for judicious and effective implementation.
The participants will be exposed to the latest concepts and thinking of international regulatory agencies on validation of manufacturing process, analytical as well as cleaning methods applicable in API & Oral Solid Dosage forms manufacturing based on assessed risk. The workshop will also include typical examples from the industry and the participants will be able to execute validations in a judicious manner.
LEARNING OBJECTIVES
FDA, ICH and EU Regulations
Process Validation
Validation Master Plan
Equipment Qualification
Risk Management Tools and Techniques
Process Design and Development
Technology Transfer
Continuous Process Verification
Analytical Method Validation
Cleaning Validation
SOPs and Best Practices
CASE STUDIES .... and More
WHO MUST ATTEND
DEPARTMENTS:
- Quality Control
- Quality Assurance
- Research and Development
- Manufacturing
- Regulatory Compliance
- Validation
- Production
- Technology Transfer
- Laboratory
- Documentation
- Training departments
PROFESSIONALS:
- Managers
- Supervisors
- Senior Managers
- Team Leaders
- Executives and Senior Executives
- General Managers
- Engineers
- Design Engineers
- Plant Managers
- Laboratory Managers and Supervisors
- Regulatory Affairs Managers
- Documentation Specialists & Analysts
