How to Survive a QRM Audit

Chinmoy Roy
Instructor Chinmoy Roy
Product Id 600653
Duration 75 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

How to Survive a QRM Audit

Overview:
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.

Attend this webinar to find out what regulatory agencies always look for when auditing a company QRM system. Addressed will be QRM compliance requirements such as critical steps for establishing a QRM infrastructure, factors to consider when developing risk ranking criteria and heat maps, what and how to fill in the templates to document QRM results and what regulatory agencies expect when you communicate your QRM results to them and other stakeholders.

Areas Covered in the Session: Using real world examples, the webinar addresses the following:
  • Why is it important to adhere to the ICH Q9 process
  • What are the principles and elements of QRM
  • Who are the key members of a QRM team and their roles and responsibilities
  • What are the various risk assessment tools and how to select one that is appropriate
  • QRM documentation strategy and how to document QRM results using templates
  • What are the key elements for developing a communication plan for QRM results
  • How is QRM audited
  • How to prepare for the audit and how to defend the audit
Who Will Benefit:
  • Development
  • Laboratory
  • Process and Manufacturing Sciences
  • Engineering
  • Quality
  • Compliance, Regulatory
  • Consultants
Speaker Profile
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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