Webinars >>Quality Management System
Best Practices to Create FDA Audit Ready Quality Systems
​(Attend Live or Access Recording)
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​Non-compliant QC and QA practices form the root of practically all the findings during FDA audits and are the most common reasons for delays in market approval. It is required to control quality of the goods manufactured via robust quality control (QC) and quality assurance (QA) processes. The practices followed by an organization should be described in the Quality Manual (QM), and form the core of the Quality Management System (QMS). Principles of QC and QA are poorly understood by many companies. Many organizations either use the two terms interchangeably, or do not have a clear distinction between the two aspects of quality. The issues are aggravated in resource-limited settings where QC and QA functions are merged and/or performed by the same individuals.​
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Areas Covered in the Session:
  • Key regulatory definitions and guidelines for QC, QA, QM, and QMS
  • FDA’s expectations from QC and QA:  Regulatory intent
  • Best practices for creating robust QC and QA departments at companies of all size
  • Common issues with combined QC and QA departments and how to avoid them
  • Requirements for personnel, training, and documentation practices
  • Applying concepts of QC and QA to all compliance areas: GMP, GLP and GCP
  • Common FDA Findings 
Why should you attend:
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This seminar will discuss the common Quality Assurance and Quality Control related finding at an FDA audit and ways to address them. Key differences between QC and QA, along with best practices to manage the two aspects of quality for better performance and compliant practices, will be discussed. Easy solutions to common issues with QC and QA practices will be discussed using case studies and examples. 

Whether you are setting up a new quality system or managing an existing one, this seminar will give you tips to reasonable methods for easy compliance with FDA requirements. This webinar, presented by a leading QA expert will discuss the key elements of QC and QA, the Quality Manual, and the overall QMS from the perspective of an FDA auditor. Key components of each element along with tips to prioritize critical steps to compliance will be discussed. Special considerations in resource-limited settings will be discussed. What works and what doesn’t in creating QC and QA departments, training of personnel, documentation requirements, and compliance checks. The seminar will highlight key strategies to maintain high quality operations that can assure controlled operations, acceptable product, and robust documentation systems. Common errors and potential solutions will be discussed using examples and case studies.
Who will benefit:

This webinar will provide valuable assistance to all personnel in: 
  • Regulatory Affairs Personnel
  • Quality Assurance Personnel
  • Quality Control Personnel
  • Project Managers - Regulatory and Clinical
  • Vice presidents, Directors and Managers
  • People interested in investing in the FDA-regulated industry
Date: June 17, 2024
​Duration: ​60 Minutes
​Time: 12 PM EST

Speaker: Mukesh Kumar 
PhD, RAC | Brij Strategic Consultations,  USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: [email protected]