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ISPE Asia Pacific Launch Workshop on:

Cleaning

Validation

Bangkok, Thailand | 16-17 October 2017

Jakarta, Indonesia | 18-19 October 2017

Cleaning Validation Workshop

Workshop Overview

Cleaning Validation Workshop is a 2-day strategic program focusing on the current guidelines, ways to effectively comply with the regulator’s expectations. The course is designed to be an interactive workshop to incorporate both theory

and practical exercises.

 

On Day 1, you will be able to understand the theory of cleaning and different cleaning processes.  

On Day 2, you will gain first hand experience in conducting practical limit calculations for both solid and liquid dosages. 

​

Additional benefits of this workshop will include interacting and learning from your peers. This is your unique opportunity to discuss the challenges and

problems that you are facing. 
 

ISPE Thailand Cleaning Validation Workshop

Ambassador Hotel, Bangkok

16-17 Oct 2017

9.00AM-5.30PM

Registration begins at 8.30am

ISPE Indonesia Cleaning Validation Workshop

Titan Centre, Jakarta

18-19 Oct 2017

9.00AM-5.30PM

Registration begins at 8.30am

Day 1

Theory of Cleaning Validation 

 

  • Cleaning Regulatory Requirements

    • Overview of cleaning guidelines

  • Cleaning Mechanisms &  Agents 

    • ​Different Cleaning Mechanisms

    • Which is the best one? 

  • Cleaning Methods 

    • ​CIP vs COP

    • Manual Cleaning 

  • Worst Case Selection

    • ​Soil

    • Equipment

  • Define Critical Quality Attributes (CQA) & Critical Process Parameters (CPPs)

  • Sampling Methods

Presentations, materials and discussions are conducted in English.
Day 2

Practical Applications & Workshops

 

 

  • Practical Exercise: Limit Calculation for Solid / Liquid dosage (Group splits into smaller groups)

  • Ultrasonic Cleaning for Tablet Press Toolings

  • How to correctly choose hygienic pumps that are important to use in CIP

  • Efficacy and Detergent Selection​

    • Cleaning Variables/Factors that influences cleaning effectiveness and performance

    • Cleaning agents, which are recommended and how to remove them

    • ​Selecting the right detergent

      • Acid
      • Base
      • Alkaline
    • Combination of the cleaning processes

      • Acid Wash

      • Base Wash

  • Detergent Residual limits

  • Case study or interactive discussion with audience

Agenda
Speakers
Organized by
Sponsored by
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