make-cleanrooms-compliant-to-iso-and-regulatory-requirements

Make Cleanrooms Compliant to ISO and Regulatory Requirements

Live Webinar

  • 60 minutes
  • 20 Days Left
     Aug 28, 2020
  •   01:00 PM - 02:00 PM ET
    10:00 AM - 11:00 AM PT

Cleanrooms are controlled manufacturing environments to achieve conformity to product requirements. This webinar is designed to provide a better understanding of cleanroom concepts through various stages from design, operation, validation, and continual certification. The webinar will also help focus on cleanroom classification, navigate through multiple standards, and to ensure continued compliance with Regulatory, ISO and client contractual requirements.

Join this session with expert speaker Ajit Basrur, where he will highlight the importance of Cleanrooms by covering various stages and topics such as design, standard, classifications, and more.

Session Highlights:

This webinar will cover the following topics. 

  • What is Cleanroom? 

  • What are the different types of Contamination?

  •  How to control contamination? 

  • Cleanroom Design 

  • Cleanroom Standards 

  • Cleanroom Classification 

  • Cleanroom Operations 

  • Cleanroom Monitoring (ISO 14644, EU and FDA requirements)

Why You Should Attend:

You will learn the insights into various attributes related to non-viable particulate monitoring, viable microbiological monitoring, differential pressures, HEPA filters, cleanroom operations and other parameters that are very important to maintain the suitability of the cleanroom for its intended purpose and to comply with the recently revised ISO 14644-1 and ISO 14644-2 standards, together with US FDA and EU requirements.

Who Should Attend:

  • Quality Managers (QA/QC) 

  • Quality representatives (Quality Engineer, Quality Systems Engineer etc.) 

  • Operations Manager 

  • CAPA Managers 

  • Management Representative 

  • Internal Auditors 

  • Training Manager


You may ask your Question directly to our expert during the Q&A session.
** You can buy On-Demand and view it at your convenience.


Ajit Basrur

Ajit Basrur

Ajit Basrur is an experienced quality professional in Pharmaceutical and Medical Devices with over 35 years of experience in global compliance. He is a Certified Lead Auditor for ISO 9001, and ISO 13485 quality management systems. He is also ASQ Certified Pharmaceutical GMP Professional, Certified Medical Device Auditor and a Scientific Peer Reviewer for ASQ’s Software Quality Assurance.

Ajit has vast experience in pharmaceutical quality systems across 21 CFR Parts 210/211, ICH, IPEC and WHO standards and Guidelines for cGMP and GDP (Good Distribution Practices); experience in medical device quality systems across 21 CFR Parts 800-821 and 830, 21 CFR Part 4, ISO 13485, EU MDR, CMDCAS, JPAL, RDC ANVISA (Brazil), and MDSAP standards; and Cosmetics experience across FDA and EfFCI Guidelines. His expertise is in audits, compliance, quality system remediation, and establishing quality systems to meet regulatory and customer expectations He has a strong track record of success in remediation efforts driving effective results in difficult situations on a global basis.

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