Limited Offer: 1 for 1 deal until 30 Jun

ISPE TRAINING: Pharmaceutical Water Systems (T35)

27-28 Aug: Parkroyal Marina Bay Hotel, Singapore

Overview

Pharmaceutical Water is, perhaps, the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. In addition to non-compendial systems, pharmaceutical facilities typically include systems for delivering pharmacopoeial Purified Water (PW) Water for Injections (WFI), and Highly Purified Water (HPW).

This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters will be covered. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.

What You Will Learn

  • Examine methods for proper water quality selection and receive detailed guidance regarding the choice and use of appropriate construction materials and instrumentation. Particular attention will be paid to
  • System and component sanitisation procedures and microbial control
  • Guidance regarding appropriate monitoring programmes during ongoing operation as well as during initial system qualification.

Resources and Activities
 

  • Pre-Course Work Materials
    • This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.
    • The course will also cover regulatory requirements including USP, EP, and JP Monographs, the USFDA Guide to Inspections of High Purity Water Systems, current FDA views, and current Good Manufacturing Practice (cGMP) requirements. Common water system myths will also be explored and a variety of practical system designs will be evaluated for EP, EMA, USP and FDA compliance, as well as their advantages and disadvantages. Particular attention will be paid to system and component sanitization procedures and microbial control.
  • Interactive Exercises
  • Learning Assessments
  • Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
  • Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases


Course Modules

  • Regulatory
  • Planning and Programming
  • Basic Water Chemistry and Microbiology
  • Pretreatment and Purification Processes
  • Choice of Systems and Processes
  • Basic Chemistry and Microbiology
  • Storage and Distribution Configurations
  • Storage and Distribution Design
  • Rogue, Stainless Steel and Passivation
  • Tradition, Risk and Science Based Water System
  • System Sampling

Who Should Attend

  • Pharmaceutical professionals who are new to water treatment systems or those with significant engineering expertise from another industry who need to learn about pharmaceutical water treatment systems
  • Those with significant industry experience in other capacities that now have water generation system engineering and/or maintenance responsibilities and want to gain a fundamental understanding of the requirements for designing, building, operating, testing, and maintaining these systems
  • Water treatment systems quality assurance and quality control specialists, manufacturing supervisors, technical support personnel, and all levels of management who want to gain a fundamental understanding of pharmaceutical water generation systems
  • Professionals who are new to pharmaceutical water distribution systems
  • Those with significant engineering expertise from another industry who need to learn about pharmaceutical water distribution systems
  • Quality assurance and quality control specialists, manufacturing supervisors, technical support personnel, validation personnel, and all levels of management who want to gain a fundamental understanding of pharmaceutical water systems

Led by

Anders Widov
Sales Director
BWT Pharma & Biotech AB

Registration

Register for 27-28 Aug: Parkroyal Marina Bay Hotel, Singapore:

Limited Offer: 1 for 1 deal until 30 Jun

Member - US$ 895 / SGD 1,195
Non-ISPE Member - US$ 1,095 / SGD 1,485
Government / Academia / Emerging Economies - US$ 550 / SGD 735

Register Now