Process and Cleaning Validation

Training

One-day training on validation according to the current understanding: design phase, qualification phase and continuous verification. The traditional way of validation, where a protocol is simply performed 3 times, is definitely behind us. Since the beginning of this century, several guidelines have been introduced in which the development and planning phase have become increasingly important in the life cycle of a pharmaceutical product or GMP system (and nowadays GDP). The emphasis is on Quality by Design, setting up Design of Experiments, performing risk analyses and establishing an efficient control system. Organizations often experience too late that their validation approach is insufficiently robust and therefore experience problems, such as registration or inspections, but also because processes do not run as expected. A solidly planned approach to validation is necessary to comply with regulations, but also to avoid financial and quality risks. The implementation of the underlying systems is also covered, such as Data Integrity, Good Documentation Practices and Risk Management which are very important components for the proper design of validations. PCS has introduced this training, in which this vision on validation and the underlying quality enablers are extensively covered. This training is for employees in the pharmaceutical industry who are involved in designing, implementing and collaborating on validation. For validators, production staff, QC, auditors, QA, QPs and managers

Content

• Purpose of validation
• Laws and regulations (including Annex 15, ICH Q8, Q9, Q11, FDA)
• Design and execution of process validation
• Design and execution of cleaning validation
• Quality by design
• Risk analyses
• Establishing an efficient control system
• Data Integrity as an important part of validation
• Validation Master Plan
• Reporting
• Workshops - learning by doing