Webinars >>SOPs
How to Write Perfect FDA-Compliant SOPs: Stepwise Instructions
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Deficiencies in Standard Operating Procedures (SOPs) rank among the top 5 findings during FDA audits at FDA-regulated organizations. SOPs play a crucial role as the cornerstone of Quality Management Systems (QMS) and compliant operations. However, SOPs often fall short, lacking essential elements and tools necessary to enhance compliance. Furthermore, they are frequently difficult for personnel to understand, being poorly written, communicated, monitored, and enforced.

This highly anticipated webinar provides a direct and comprehensive approach to addressing the issues surrounding SOPs. Led by an industry-leading expert with extensive experience in crafting and reviewing SOPs for hundreds of FDA-regulated organizations, it provides step-by-step instructions for creating and implementing effective SOPs. Through the use of case studies and examples, common errors and potential solutions will be highlighted. Additionally, the seminar will cover the logistics of creating, maintaining, scoping, training, and documenting SOPs. The pros and cons of paper and electronic SOPs will also be discussed.
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The seminar draws upon the trainer's wealth of knowledge gained from extensive FDA audit experience, offering practical tips to enhance your organization's compliance. By addressing deficiencies in SOPs, you can avoid the pitfalls that often result in FDA 483s and Warning Letters. Join us in this seminar to ensure that your SOPs align with FDA compliance standards.
Why should You attend:

1. Evaluate Your Current SOPs: Gain the knowledge and tools to assess your existing SOPs for the most common issues identified by the FDA during audits. Identify gaps and areas for improvement, allowing you to proactively address compliance concerns.

2. Practical Tips and Tested Strategies: Acquire practical tips and tested strategies for creating, revising, updating, training, and documenting SOP processes within your organization. Unlock the secrets to creating robust, compliant SOPs that enhance operational efficiency.
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3. Case Studies and Key Concepts: Our speaker will share enlightening case studies that illustrate core concepts and alternative approaches to compliance. You will walk away with a deep understanding of the least-burdensome approach to meeting FDA regulations effectively. 
 
Don't let deficiencies in your SOPs compromise your organization's compliance efforts and FDA audit outcomes. Allow us to assist you in enhancing your SOPs, strengthening your quality management systems, and achieving seamless compliance.
Areas Covered in the Session:
  • Essential elements of an SOP
  • Process mapping techniques to define the contents of an SOP
  • Role of personnel in creating SOPs
  • SOP revisions, updates, creation, retirement and documentation
  • Categorization of SOPs
  • Assessment of compliance techniques
  • Training practices for FDA compliance
  • Access and access control to SOPs
Who will benefit:
  • QA/QC/compliance/regulatory professionals
  • Senior management executives (CEO, COO, CFO, etc)
  • Manufacturing managers, supervisors and personnel
  • Clinical and preclinical laboratory managers
  • Clinical trial specialists
  • Project managers
  • People investing in FDA-regulated product development projects
Date: July 12, 2023
Time: 12 PM EST
​Duration: 60 Minutes

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: info@fdamap.com