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Cleaning Validation - Current Regulatory expectations, A Different Perspective


A gap in the effective cleaning procedures raises critical concerns over the integrity of product quality, safety and efficacy, in just the same way critical data integrity issues result from a gap in data. The perception in validation circles that cleaning validation is a generic version in the list of validations may not be right, since cleaning validation requires the use of different Acceptance Criteria for deciding the effectiveness of cleaning.
Having said this, cleaning validation professionals are left wondering how to fix issues, how effective the correct approach is, how to design and perform the cleaning validation studies, etc. How valid are the traditional concepts in the light of changing expectations from the regulatory agencies?
The way out is to employ a risk based approach to design a cleaning validation plan, as the rationale and procedures being used by most companies are turning out to be low on reliability.
A meaningful learning session from Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, will show how to pass this crucial test.
Vikram Kulshreshta, a Senior Management Professional with a strong experience in Quality Assurance & Regulatory Affairs, will be the speaker at this webinar, which is being organized on July 22. Please log on to register for this learning session.
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This webinar will explain the advanced basics to be considered for carrying out a successful cleaning validation study. The expert will describe the various advancements in evaluating the effectiveness of cleaning that have evolved over the years, which will help the participants determine what kind of studies are required to make cleaning a solid activity, which, when integrated into the process, ensures quality, safety and integrity in the product.

He will offer a different and deep insight into cleaning validation, which will enable the participants to think differently and look at an approach that is at variance with the generic one. All middle & senior management persons in pharmaceutical industry will benefit from this presentation, which will include the following topics:
  • Different concepts in Industry for Cleaning validation
  • Approaches to derive Acceptance Criteria
  • How can we design an effective Cleaning validation plan?
  • Regulatory Expectations
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About the speaker: Vikram Kulshreshta is an expert in designing and implementing the Quality Systems, Qualifications & Validations, troubleshooting and CAPA implementation, and Regulatory Affairs. He has been in the industry for more than 30 years, during the course of which he has gained expertise in international cGMP regulations such as those of the USFDA, MHRA, TGA, ANVISA, MCC, and COFFPRIS Mexico. He has conducted interactive workshops on QMS elements, with real life examples through interactive approaches and case studies. His methods have enhanced learning benchmarks for the participants.
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