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HomeManufacturing & Good Manufacturing Practices (GMP) TrainingPharma Water Systems: Commissioning and Qualification to Ensure Compliance

Pharma Water Systems: Commissioning and Qualification to Ensure Compliance

Teachers
Peter T. Vishton, P.E.
Category:
Manufacturing & Good Manufacturing Practices (GMP) Training/ On-Demand Courses/ Quality/ Regulatory & Compliance/ Research & Development/
Clear

— OR —

Duration: 90 minutes
On-Demand
Includes handouts
  • Course Description
  • Who Should Attend
  • What To Expect

Course Description

OVERVIEW

The pharmaceutical research and development (R&D) process requires water. Not just any water, but pharmaceutical grade water. Throughout the process, water is used as an ingredient, a cleaner of manufacturing equipment, and a key element of quality testing. If a company cannot meet and maintain legally-required water standards, they cannot sell their products.

Furthermore, employees are required to be knowledgeable about pharma water system requirements to assure their employers produce safe products. The knowledge includes the principles of producing pharmaceutical grades of water to established minimal standards, storing it in quantities to meet production needs, and distributing it to several points of use while maintaining the minimal chemical and microbial requirements. Training of personnel to assure the water produced meets and maintains standards is critical to a company’s success. US Food and Drug Administration (FDA) regulatory observations and enforcement actions regarding water systems continue to plague industry. To add pain to the process…it isn’t cheap. This session will teach you ways to remain compliant and increase efficiencies through best practices.

LEARNING OBJECTIVES

During this course, you will…

  1. Review the production of Pharma Water from feed water to Points-of-Use
  2. Identify common pitfalls and problem areas when commissioning and qualifying your water systems, and the problems FDA cites most frequently
  3. Contrast what makes for a good water systems program, and what will ensure failure
  4. Prepare your efforts with best practices from an industry veteran
  5. Receive job aids and other resources to help you with your efforts

Additionally, you will discover…

  • The different grades of pharm water and their uses
  • The multitudes of pharma water production equipment and configurations in use
  • The differences in existing global regulations

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to personnel working for pharmaceutical companies in areas of:

  • R & D
  • Product manufacturing
  • Quality testing
  • Technical support
  • Regulatory/Compliance

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Contact us at 215-675-1800, Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Peter T. Vishton, P.E.
Peter is an Independent Pharmaceutical Water Systems Consultant working with several companies. He has 25 years of experience in the Pharmaceutical area which includes 10 years with Pharmaceutical Water Systems.

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Clear

— OR —

Duration: 90 minutes
On-Demand
Includes handouts

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