Skip To The Main Content

PDA 399.1 Design, Operation, and Qualification of Pharmaceutical Water Systems

Dec 13 - Dec 15, 2022
8:30 AM
-
4:00 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

This online training course provides a summary of compendial water systems from generation through storage and distribution. Feed water impurities and their impact on system design, operation, and maintenance will be discussed. The validation process is discussed from Validation Master Plan, URS, FRS, FMEA, IQ/OQ/PQ through long-term monitoring throughout the training course. Numerous case histories and “hands on” observations will be discussed to demonstrate proper design, operation, qualification, monitoring, and proactive preventative maintenance. A section of the training course will discuss non-distillation based Bulk Water for Injection Systems. The training course content will be valuable to any individuals interfacing with bulk compendial water systems from design, engineering, operation, manufacturing, Quality Assurance, compliance, maintenance, monitoring, and excursion evaluation.

For more options and/or related training courses, please visit the page(s) below.

PDA Facilities Training Courses

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Session 1 - Rules, Regulation, Guidelines, & Qualification Criteria (90 min)


    Break (15 min)


    Session 2 – Impurities in Raw Water (90 min)


    Break (60 min)


    Session 3 – Pretreatment Techniques (90 min)


    Break (15 min)


    Session 4 – Ion Removal Techniques: Ion Exchange & Reverse Osmosis (90 min)

  • Session 5 – Polishing Ion Removal Techniques & Accessories (90 min)


    Break (15 min)


    Session 6 – Distillation & Pure Steam Generation (90 min)


    Break (60 min)


    Session 7 – Storage Systems & Accessories (90 min)


    Break (15 min)


    Session 8 – Ozone (90 min)

  • Session 9 – Distribution Systems (90 min)


    Break (15 min)


    Session 10 – Validation (90 min)


    Break (60 min)


    Session 11 – Instrumentation, Controls, Monitoring, & Preventative Maintenance (90 min)


    Break (15 min)


    Session 12 – Non-Distillation Water for Injection Systems (90 min)

Trainers

William Collentro
William Collentro

Learning Objectives

  1. Evaluate the design of a compendial water system, considering feed water characteristics, from generation through storage and distribution
  2. Understand the importance of initiating system qualification throughout the design, engineering, risk assessment, installation, commissioning, protocol generation/execution, procedure preparation, monitoring program preparation, and proactive maintenance program
  3. Using exposure to both “hands-on” and case histories, understand the numerous potential pitfalls that should be addressed for compendial water systems
  4. Recognize the importance of system monitoring including sample collection, and analysis. For compendial water samples, understand the value of “delivered” water samples
  5. Understand the importance of a comprehensive proactive maintenance program in eliminating costly unplanned shutdowns

Who Should Attend

This training course is intended for professionals who are from multiple disciplines that interface with compendial water systems.

Departments
  • Quality Control
  • Quality Systems
  • Quality Compliance
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Regulatory Affairs
  • Technical Operations
  • Training
  • Validation
  • Facilities

Roles
  • Analyst
  • Specialist
  • Operator/Technician
  • Supervisor
  • Manager
  • Director
  • Engineer
  • Scientist
  • Auditor/Inspector

Registration Fees

Register Now
Registration Type Price
All Participants $1,799

Got a Question? We have answers

Contact Us
Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Media Partners

PDA Members Save Substantially