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 Speaker Profile

Chinmoy Roy
Biopharma Consultant,

Chinmoy is a seasoned Life Sciences professional. His expertise includes the design, delivery and validation of industry compliant computerized and control systems for pharmaceutical and biotech manufacturing. His focus is on finding lean integrated manufacturing solutions to include Quality by Design (QbD) and Quality Risk Management (QRM).

He has more than 35 years of hands on industry experience in directing the implementation, validation and obtaining “fit for use” certification of large biopharmaceutical manufacturing automation and IT systems. These systems conform to regulatory requirements such as CFR 21 Part 11 and Annex 11. He has a very broad experience in facilitating QRM sessions for large US companies and has provided them with consultant oversight to establish their Quality Risk Management plans.

His training sessions are unique in that he combines his field experience to explain the intricacies of applying the regulations. Such an approach of blending theory with practical applications has provided his trainees the necessary skills to lead regulatory efforts in their respective organizations

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Key Steps for Risk Assessment

The webinar focuses on effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as those of the regulators and thereby significantly reduces your companies exposure to audit failures.

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How to Develop, Monitor and Effectively Communicate your Risk Control Strategy

The intermediate level webinar assumes that attendees are conversant with the basic concepts of QRM. It addresses how to document the results of QRM in a RCS document, techniques to continuously monitor RCS performance and reporting of risk events and remediation to stakeholders. Subsequently, the focus shifts to the development of a process framework to manage risk through activities such as monitoring and communication of the RCS to the diverse group of stakeholders.

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How to Survive a QRM Audit

As QRM tools and techniques become more formalized, regulatory agencies are increasingly requiring companies to establish Quality Risk Management Plans for their operations. Such plans are being used as starting points for regulatory audits. Additionally, to keep in step with the evolution of science and technology, agencies are frequently updating their approach to auditing quality and risk management. This dynamic nature has significantly contributed to an increase in citations. Consequently, companies should become familiar with performing QRM activities that meet compliance requirements.

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How to Bullet Proof your Documents from Most Commonly Cited GDP Violations

Good documentation is a cornerstone for good operational practices in any biopharmaceutical company. While documentation is a CFR requirement, there is no specific regulatory guidance on good documentation practices. A company’s documentation system and practices are vital to a successful audit since it provides regulators a window into the company’s operations. It is one of the systems which always attract the attention of regulators.

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