How to Perform investigations in Pharmaceuticals

Course Title: How to Perform Investigations in Pharmaceuticals

Headline: Master the Art of Conducting Investigations in the Pharmaceutical Industry 🏫💊

Course Description:

Are you ready to delve into the world of pharmaceutical investigations and ensure compliance within your organization? This comprehensive online course, led by the esteemed Hitendrakumar Shah, is designed to equip you with the essential skills and knowledge required to perform thorough and effective investigations in the pharmaceutical industry.

Why This Training Matters:

• Understanding the Necessity of Investigation Training: Gain insights into why comprehensive training on investigation processes is indispensable for maintaining high standards in the pharmaceutical sector.
• Investigation Tools Overview: Learn about various tools used during investigations and how to document their use effectively.
• Compliance Achievement: Discover strategies to meet regulatory requirements and ensure your organization remains compliant.

Course Outline:

1. Out-of-Specification (OOS) Results:

   • Understand FDA requirements for OOS investigations.
   • Dive into Phase 1 and Phase 2 investigations with practical examples.
   • Analyze common OOS issues and learn about outlier tests, retesting, and resampling considerations.
   • Explore real-world examples of three sigma and six sigma in Out of Trend (OOT) evaluation.

2. Investigating Human Errors:

   • Uncover the consequences of human errors within the pharmaceutical industry.
   • Learn effective methods for investigating human errors, including the use of models like the Swiss cheese model and four quadrant models.

3. Good Review Practices:

   • Grasp the importance of good review practices in maintaining quality standards.
   • Examine examples of FDA citations to understand regulatory expectations.
   • Learn about the 10 key principles of good review practices and qualifying reviewers.

4. Quality Risk Management (QRM):

   • Simplify your understanding of Quality Risk Management principles.
   • Discover practical, easy-to-implement strategies for achieving compliance through QRM.

Course Highlights:

• Real-World Examples: Benefit from practical examples and case studies throughout the course to solidify your understanding.
• Regulatory Compliance Focus: Stay ahead of regulatory expectations and ensure your processes are up to scratch.
• Expert Guidance: Learn from an industry expert, Hitendrakumar Shah, who brings years of experience and knowledge to the table.

What You Will Learn:

• The types of investigations conducted in the pharmaceutical industry and their significance.
• How to record and document your investigation findings for compliance purposes.
• The common mistakes made during investigations and how to avoid them.
• A step-by-step approach to handling OOS results, including FDA requirements and best practices.
• Strategies to reduce human errors and improve overall process integrity.
• Good review practices that align with regulatory standards and expectations.
• The principles of Quality Risk Management and how to apply them effectively in your organization.

Join Now! 🚀

Embark on a journey to become an expert in pharmaceutical investigations with our insightful course. Whether you're a quality assurance professional, a regulatory affairs specialist, or simply looking to expand your knowledge, this course is tailored to help you excel in your role and ensure the highest level of product quality and patient safety.