This 4 day intense and interactive program will review all aspects of Validation. The delegates will learn how to implement and maintain validation across their companies. Also they will be receiving guidance to help answer the question, ‘How much validation is enough?’ Delegates will learn the procedures necessary for validation and how to write and maintain protocols. Delegates will be learning what SOP’s and Protocols are required for each type of validation. This training also guarantees that delegates will learn microbiological topics, terminology, and regulatory expectations as well. They will be introduced to current requirements for microbiological recovery methods validation.
Everyday subjects performed within the microbiology laboratories will be useful to employees responsible for understanding, interpreting and reviewing microbiological testing data. They will learn understanding of how organisms enter controlled environments, what it takes to reduce the number of organisms once contamination occurs, how to prevent contamination in the first place, and the work necessary to validate microbial recovery methods.
It focuses primarily on the large group of team members whose work is essential to a validated process, but who do not spend the majority of their time on validation. Training will also cover equipment validation, FAT, SAT, URS, DQ, IQ, OQ, PQ, MQ topics in detail. Cleaning Validation and Computerized System Validation are discussed entirely and delegates will leave by comprehensive understanding of Validation. Several Risk management tools such as HACCP, FMEA, FTA used for reviewing Validation status will also be discussed in detail.
Who Should Attend
This 4 days program is designed for those personnel who have a key role or provide input into all Validation activities directly or indirectly:
- Validation Team
- Validation Supervisors / Managers
- Quality Assurance
- Manufacturing Team
- Quality Control Team
- Analytical & Microbiological Team
- Regulatory Affairs Team
- GMP Compliance Team
- IT Team
The course consists of instructor led presentations, group exercises/practicals, and discussions. Copies of all presentation slides and handouts will be provided. Participants are encouraged to bring their investigations or deviations/incidents with them.
The course will address the following:
- Analytical Method Validation
- Process Validation from A to Z with new FDA Draft Guideline
- Cleaning Validation
- Microbial Control & Validation
- Validation Master Plan
- Validating Critical Utilities
- Writing Validation Protocols
- Network Qualification & Validation
- FMEA & Six Sigma and Validation
- Handling Validation Deviations
- Test Method Validation
- Auditing Validation Practices
- FDA, PIC, MHRA, EMEA, EU GMP Approaches to Validation (Including new guidances)
- ASTM E2500
- Documentation and Validation
- Acceptance Criteria and Validation
- Computer System Validation (CSV)
- Software Validation
- Risk Management and Validation Issues
- Clean room and Environmental Validation
- Equipment Validation (Covers lab and manufacturing, testing, measuring devices-equipments)-Data Loggers-Mapping etc.Effective deviation management system for improvement
Tel : 00 90 212 599 75 62
Fax: 00 90 212 599 75 62
Click here to download the course overview.