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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