Update on ISO and Regulatory Requirements for Cleanroom Compliance

Event Information
Product Format
Prerecorded Event
Conference Date
Wed, Sep 26, 2018
60 minutes
Product Description

Learn How to Identify the Gaps in Your Procedures and Comply with ISO, FDA and Client Contractual Requirements

Cleanroom contamination is a serious issue, and can lead to costly shutdowns and product recalls – besides damaging a company’s reputation. And with the recently revised ISO 14644-1 and ISO 14644-2 standards, coupled with U.S. FDA and EU requirements, manufacturers and cleanroom managers are facing serious compliance challenges. Since even a single event can disrupt your operations, why take a chance?

In this webinar, industry veteran Ajit Basrur will teach you how to identify and fix the gaps in your existing cleanroom procedures and practices, and achieve continued compliance with regulatory, ISO and client contractual requirements. Basrur will decode cleanroom concepts, and walk you through the stages you should know about – such as design, standards, classification, operation, validation, and continual certification. You will learn about the different types of contamination – as well as how to control and monitor the contamination. Basrur will provide valuable insights on the important parameters that are necessary to minimize contamination and achieve compliance – including the attributes related to non-viable particulate monitoring, viable microbiological monitoring, differential pressures, and HEPA filters.

After attending this session, you will be able comply with the recently revised ISO 14644-1 and ISO 14644-2 standards, along with the U.S. FDA and EU requirements.

Session Highlights

Here’s a taste of what you will learn in this instructive session:

  • What is a cleanroom?
  • What are different types of contamination?
  • How to control contamination?
  • Cleanroom design
  • Cleanroom standards
    • ISO 14644 series
    • USP
    • FDA guidance
    • ISO 14698 series
    • PDA technical report number 13
    • Eudralex
  • Cleanroom classification
  • Cleanroom operations
  • Cleanroom monitoring (ISO 14644, EU and FDA requirements)

Who Should Attend

  • General managers
  • QA/QC managers
  • CAPA managers
  • Compliance officer
  • Quality engineers
  • Facility maintenance
  • Operations manager
  • Management representative
  • Internal auditors
  • Any other team member from the quality, and operations departments wishing to understand cleanroom environment

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Ajit Basrur


Ajit Basrur is an experienced quality professional in Pharmaceutical and Medical Devices with over 30 years of experience in global compliance. He is a certified Lead Auditor in ISO 9001 and ISO 13485 and ASQ CBA. Ajit has vast experience in quality system elements of 21 CFR Part 820, 21 CFR Parts 210 and 211, ISO 13485, ISO 9001, European Medical Device Directive (93/42/EEC), Japanese MHLW...   More Info
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