Pharmaceutical Water Systems – Validation, Monitoring and Inspection Preparation


2-Day In-Person Seminar (Code – INDSEM122)

Pharmaceutical Water Systems – Validation, Monitoring and Inspection Preparation


    Hyderabad, TS, India

 

    May 16 – 17, 2019

Seminar DescriptionAgendaPricingVenue
Pharmaceutical Water Systems are critical to routine manufacturing of product as well as for use within the cleanroom (Room Disinfection). Some water systems are also used to generate feed water which is critical to the manufacturing of product.

Difficulties and associated water failures and investigations, have led to several product manufacturing delays due to inability to use the affected water for the manufacturing of product as well as for their cleanroom operation. The cost associated with failure investigation, failed water system and impact to the manufacturer operation is high hence having a good knowledge of these requirements and how to apply it to new or existing water systems will benefit the attendee.

Why You Should Attend:

This seminar will help the attendee gain an understanding of the requirements of Pharmaceutical Water Systems per current USP <1213> Water for Pharmaceutical Purposes. This seminar will describe the different types of pharmaceutical water systems, the importance of Validation, Monitoring, design and routine testing.

This interactive workshop will also guide drug product manufacturers with a new or existing water system about the appropriate types of testing, frequency, as well as Water System Investigation.

WHO SHOULD ATTEND

  • Quality Assurance Personnel and Management
  • Quality Control Personnel and Management
  • Laboratory Managers
  • Testing Analysts and Technicians
  • Manufacturing Personnel and Management
  • Suppliers and Vendors of Pharmaceutical Water Systems
  • Validation Personnel and Management
  • Supplier Quality Assurance Personnel and Management
  • Regulatory Affairs Personnel and Management
  • Shipping and Receiving Personnel and Management
  • Facility and Maintenance Personnel and Management
  • Microbiologist Personnel and Management
  • Engineering Personnel and Management
  • Materials Management Personnel and Management

DAY 1 : (8.30 AM – 5 PM)

Registration: 8.30 AM – 9 AM

  • Regulations Guiding Pharmaceutical Water
  • Current USP <1213> Pharmaceutical Water System
  • Types and Uses of the Different Pharmaceutical Water Systems
  • Planning the Design of a Pharmaceutical Water System
  • Evaluating the Supplier or Vendor of the Pharmaceutical Water System
  • What Makes Water Systems Have Microbial Quality Problems
  • Successful Sanitization Approaches for Trouble-Free Water Quality
  • Water System Validation by Logic
  • Test Method Validation
  • Special considerations for lab water systems
  • Implementing Changes to a Validated System
  • Reducing Water Microbial Excursions & Improving Investigations


DAY 2 : (9 AM – 4.30 PM)

 

  • Routine Testing Programs for Pharmaceutical Water (Post Validation)
  • Best Practices to consider when testing pharmaceutical Water
  • Understanding and Controlling Endotoxin
  • Harmonizing vs Optimizing Water Microbial Testing for System Quality Control
  • Issues with High Purity Water Systems
  • Pharmaceutical Water Failure
  • Water System Investigation “How-To” and Example Case Studies
  • Water Testing Data Management
  • What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues
  • Review of Case Studies – FDA Recent Form 483 Applicable to Pharmaceutical Water


PRICING OPTIONS & REGISTRATION

Seats and Accommodation are limited and based on first-come, first-serve

 

Mercure Hyderabad KCP, Banjara Hills

Hyderabad, TS, India | May 16 – 17, 2019


Call for Assistance: +91-80-4170-0521   Register Now