Introduction for Water Purification, Storage and Distribution System in Pharmaceutical/ healthcare industries (Purified Water System)
- 3 days (2 days can be customized)
- Course fee
Topics to be covered with this training includes:
- Validation and Qualification scientists, Supervisor and Manager
- Production supervisors or Manager
- The supervisor is responsible for the operation and maintenance of the water system.
- Infrastructure maintenance Technicians/Utility Engineers who are working with an HVAC system, Design, Operation, Requalification, Monitoring, and Maintenance
- Quality Department (QA, QC (Microbiology), Regulatory Affairs and Compliance)
- Quality Engineering related to staff
- calibration technicians/ engineers
- Quality Department (QA, Regulatory and Compliance)
- Quality Control lab staff and Microbiology lab supervisor who is responsible for trending for water quality specifications to achieve monitoring/control of the pharmaceutical water system.
- Professionals from service organizations, contractors, designers, and vendors who provide services for pharmaceutical Industries/clients.
- Regulatory bodies involved in pharmaceutical industries.
- Internal/External Auditors and consultant
Objectives and Expected Results
- The trainee will have proper knowledge for the monograph and non-monograph requirements for the Pharmaceutical Waters so that he/she will have a good knowledge for USP Does and Doesn't Say about PW, WFI, Pure Steam, and microbial aspects.
- The trainee will understand the role of initial phases of the system lifecycle, starting from planning, design, and maintenance for the sake of controlling microbial levels
- Participants will have a good idea about the design considerations to be taken for prevention the contamination or cross-contamination to entire critical parts of the pharmaceutical water treatment system.
- Participants will have a good idea about filters standard and classification which are used in pharmaceutical water system (Pretreatment and Purification system) as well as storage/distribution system, in addition, to have in deep knowledge about differences between each category and the intended ideal use of to meet compendial and non-compendial water specifications.
- Participants will have proper knowledge for all prerequisites to be taken prior to Qualification & Validation of Water system (Qualification Planning Approach)
- The trainee will understand the basics guidelines for engineering requirements for the pharmaceutical water system and take ideas about required supportive references and guidelines.
- The trainee will understand the role of system design and maintenance in controlling microbial levels
- Participants will be familiar with activities to be considered pre/during commissioning requirements for such customized systems that are considered critical phases of the Qualification process.
- The trainee will have proper knowledge for Developing sound Alert and Action Levels and Water quality attributes and other Specifications limits (Operation and Quality Parameters)
- Participants will understand how all Commissioning, Qualification & Validation (Q&V) activities that will interact together within the same department or among different departments to achieve an ideal team-work spirit and integrity for the sake of quality design and system handover.
- The participant will have an idea about the Pharmaceutical water System lifecycle starting from setting User Requirement Specifications (URS’s) and up to Retirements (Complete Lifecycle approach)
- Participants will be able to maintain the qualification status during the lifecycle of the pharmaceutical water system.
- The trainee will be conscious to save time, money, and increase compliance by following a Risk-Based streamlining approach to Qualification and Validation of the pharmaceutical water system as well as optimize usage and achieve proper utilization.
- Participants will take an idea about the cGMP related chemical, microbial and physical tests needed for the initial qualification and keeping the sustainability of operability the pharmaceutical water system.
- The trainee will understand the regulatory/guidelines requirements for the pharmaceutical water system including, Validation & Qualification in addition to engineering requirements /practices within the pharmaceutical/life-science industry.
- Participants will be familiar with international requirements and expectations (US, EU, EMEA and WHO, EP, USP)
- Participants will be able to discuss and handle water-related Engineering quality attributes with inspectors from both Local / and International authorities.
- The trainer will make an evaluation for the good and bad practices
- The trainee will be aware of cost-saving when designing or operation the Pharmaceutical water system.
- The participant will be aware of cost-saving when designing or operation of the pharmaceutical water system
Others Training Materials
- Workshop, Sheets, and case studies paper will be conducted and implemented during training.
- Documentary Videos will be presented.
Trainer Languages English/Arabic