Current GXP expectations on Water system validation compliance

Duration 90 Mins
Webinar ID IQW23C0376
Level Basic & Intermediate & Advanced

  • Importance of topic
  • Introduction to different guidelines and expectations
  • Different types and usage of water
  • Qualification and Validation of water purification system
  • Identify the suitability of the water system
  • Why three phases PQ or water system validation - Details
  • Sampling issues and some common problems
  • Developing Water system validation – Life cycle approach
  • Discussion on some FDA warning letter observations
  • Q&A AND Vote of Thanks

Overview of the webinar

The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, so as to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, as well as external including regulators, is “Validation”, which is the key to all systems and processes in the pharmaceutical industry. 

This session will focus on different regulatory expectations on water system validation, how to perform validation, what are common problems, how to comply with the cGMP requirements, and many more. This validation document is a long-lasting document and hence needs to perform the activity with due care.

As such, there are many open threads in the Traditional approach, which need to be discussed, explained, and closed with the help of understanding the expectations of different Regulatory guidelines.

Who should attend?

  • Quality Assurance Departments
  • Quality System Auditors
  • Manufacturing Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Engineering Departments
  • Compliance Departments
  • Microbiology Analysts and Technicians
  • Lab Personnel
  • Logistics
  • Consultants

Why should you attend?

This training session will trigger the thought process toward compliance, Multiple common non-conformities will be discussed during the session.

How to perform the water system validation is an important aspect as, water is used for many API, excipient, and formulations.

Faculty - Mr.Hitendra Kumar Shah

A Quality-oriented professional with over 23 years of experience in Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance. The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.

The key competencies include Quality Compliance, Supplier Audit, building systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation, and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post-approval queries raised by regulatory agencies, etc.


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