Validation and qualification of product as well as equipment are nowadays an integral part of the day by day routine work in the packaging industry and manufacturers are legally obligated to meet the requirements of global standards for product and equipment validation & qualification from raw materials to consumer end. Variation in the equipment or process parameters especially during packaging materials production may have a significant impact on the integrity and correct functioning of the pack, therefore packaging product process and equipment for finished and bulk products should be validated and qualified. This two days based training session addresses various topics on validation and qualification activities, validation chain, stages of qualifications, process validation, re-validation, risk management including validation global regulations and standards etc. through hands-on activities accompanied with case studies, presentations and discussion and at the end participants will leave the class with a strong understanding of advance concepts of packaging product processing and equipment validation and be able to troubleshoot a variety of product, process and equipment related issues upon return to their respective facility.
- Validation and qualification overview, principles of validation, types of validation, validation timeline, validation lifecycle, approaches in qualification and validation, V-model and importance of validation and qualification in the packaging industry.
- Equipment validation, stages of qualification, URS, FAT, SAT, DQ, IQ, OQ, PQ, AQL, RQL and SOPs on operation, cleaning, maintenance, calibration, test method validation, equipment criticality and risk Assessment.
- Validation master plan (VMP), validation summary report (VSR), validation master list (VML) difference b/w validation master plan and validation master list stages of validation, protocols, reports and inclusions.
- Process validation, elements of process validation, process validation parameters, temperature, pressure, pH, time, criteria and limits, validation effects and issues.
- Qualification and validation protocols, objectives, site, responsible personnel, SOPs, equipment, criteria, parameters, sampling, testing, monitoring requirements and calibration requirements.
- Responsibility and the responsibilities of different stakeholders i.e. quality, production, project, supply chain and maintenance.
- Qualification and validation reports, specifications, process flow charts, operator manual, sampling and testing plan, methods, statistical methods and results.
- Revalidation, validation type, requirement of revalidation, revalidation frequency, basic categories of re-validation, change management, deviation management, calibration and verification, validation schedule and documentation.
WHO SHOULD ATTEND?
- Plant Management
- NPD supervisor | Manager
- QHSE supervisor | Manager
- Quality Control team members
- Product Design Team Members
- Production Supervisor | Manager
- Plant Maintenance Personnel
- Prepress and Graphic Designers
- Initiatives and Project team members
- Printing & Packaging Technologists.
- Sales and Customer Service Representatives
- Those new to the equipment and packaging industry
- Understand of product / equipment validation and qualification, categories, timeline, lifecycle in the packaging industry and why validation is essential for any process industry.
- Demonstrate the requirements and prepare VMP and VML CQV (Commissioning, Qualification and Verification) phases for any industry.
- Organize and plan process and equipment validation in a manner that will ensure product quality, safety and efficacy through-out its life cycle.
- Able to prepare validation protocols and perform qualification and validation of new premises, equipment, utilities, systems, process and procedures.
- Identify the roles of QA, production and project teams during installation, operational and performance qualification in manufacturing plant.
- Determine process control limits, materials specifications, parameters, potential failures modes, actions levels and worst scenario in order to produce acceptable product under normal operating conditions.
- Establish and maintain procedures for monitoring and controlling of process parameters for validated processes to ensure that the specified requirements continue to be met according to global requirement and standards.