Introduction for Water Purification, Storage and Distribution System in Pharmaceutical/ healthcare industries (Purified Water System)

Engineering and Validation

Quality

Target Level

• 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

Description

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 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 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.

Target group