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

Dec 01 - Dec 03, 2020
8:30 AM
-
4:00 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online
Closed

Overview

This online training course covers compendial water requirements, discussion of impurities in feed water, water purification unit operations, storage with accessories, distribution and distribution systems, instrumentation and controls, and validation requirement. The importance of system monitoring, accumulation of data, and proactive preventive maintenance will be discussed. Microbial control from feed water through components to delivered water will be addressed including biofilm. The training course will employ numerous operation system examples to support presented material.

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

  • Welcome and Introductions (30 min)

    Definition of Pharmaceutical Waters, Regulatory and Validation Considerations (90 min)

    Break (15 min)

    Impurities in Raw Water (75 min)

    Break (60 min)

    Pre-treatment Techniques (90 min)

    Break (15 min)

    Ion Removal - Reverse Osmosis (75 min)

  • Recap Day 1 (30 min)

    Ion Removal - Ion Exchange, Deionization, and Continuous Electrodeionization (90 min)

    Break (15 min)

    Polishing Components (75 min)

    Break (60 min)

    Distillation and Pure Steam Generation (90 min)

    Break (15 min)

    Storage Systems and Accessories - Ozone System and Accessories (75 min)

  • Recap Day 2 (30 min)

    Distribution Systems, Biofilm, and Microbial Control (90 min)

    Break (15 min)

    Instrumentation and Controls - Validation I (75 min)

    Break (60 min)

    Validation II (90 min)

    Break (15 min)

    Case Histories (75 min)

Trainers

William Collentro
William Collentro
Bio
William Collentro

Learning Objectives

  1. Address compendial water system design, operation, validation, and maintenance concerns
  2. Assess microbial control importance throughout the water system
  3. Explain “delivered water” quality
  4. Discuss the criticality of proactive preventative maintenance
  5. Deduce the importance of system analytical monitoring

Who Should Attend

This training course is intended for professionals who are involved in compendial water system design, operation, maintenance, and validation.

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

Roles
  • Specialist
  • Operator/Technician
  • Supervisor
  • Manager
  • Engineer
  • Scientist
  • Auditor
  • Microbiologist

Registration Fees

Closed
Registration Type Price
Member $1,800
Non-member $1,800
Gov't/Health Auth./Academic $1,800

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