Good Manufacturing Practices (GMP) & GMP AUDITS

🚀 Master Good Manufacturing Practices (GMP) & GMP AUDIT with Confidence!

📚 Course Overview: Good Manufacturing Practices (GMP) are the backbone of quality assurance in pharmaceutical manufacturing. They ensure that every product meets its intended quality standard and is safe for human use. This comprehensive course, led by the esteemed Aydan Ozdenc, will guide you through the intricacies of GMP and prepare you for a 250-question audit simulation. Get ready to understand the critical role of GMP in the pharmaceutical industry and how to effectively conduct audits to ensure compliance with current Good Manufacturing Practices (cGMP).

Why You Should Take This Course:

• Regulatory Compliance: Stay ahead of regulatory requirements and understand the expectations from international bodies like FDA, EMA, WHO, etc.
• Risk Management: Learn how to identify and manage risks in pharmaceutical production to minimize the potential for product recalls or safety issues.
• Quality Assurance Mastery: Gain a deep understanding of the QM framework and its significance in maintaining product quality and integrity.
• Expert Guidance: Aydan Ozdenc, with years of industry experience, will lead you through real-world applications of GMP principles and best practices for audit preparation.

Course Agenda:

1. Introduction to GMP & GMP Audits 🔍

   • Understanding the importance of GMP in pharmaceutical production.
   • Overview of what to expect during a GMP audit.

2. General Information about GMP Audits 📈

   • The role and objectives of GMP audits.
   • How audits contribute to the safety and efficacy of pharmaceutical products.

3. Quality System 🛠️ 3.1. Good Manufacturing Practices (GMPs)

   • Core principles and their application in various stages of production. 3.2. Basic Requirements of Good Manufacturing Practices (GMPs)
   • Essential requirements every pharmaceutical facility must adhere to. 3.3. Pharmaceutical Quality System
   • A holistic approach to ensuring product quality from start to finish.

4. Personnel 👥

   • The role of personnel in maintaining GMP standards.
   • Best practices for staff training and hygiene protocols.

5. Premises & Equipment 🏫

   • Requirements for premises and equipment to meet GMP standards.
   • Special focus on manufacturing, storage, and quality control areas.

6. Documentation ✍️

   • The critical importance of documentation in GMP compliance.
   • Guidance on creating accurate and compliant specifications, manufacturing records, and quality control documents.

7. Production 🚫

   • Ensuring product integrity by preventing contamination, cross-contamination, and mix-ups.
   • Best practices for maintaining a clean and controlled environment during production.

8. Quality Control 🔎

   • The role of Quality Control in maintaining product quality.
   • Understanding Good Laboratory Practices (GLP) and their relevance to GMP.

9. Quality Assurance ✅

   • Implementing Product Quality Review (PQR), managing complaints, and executing change management effectively.
   • Addressing deviations through corrective actions and preventive measures.

10. Additional Audit Questionare 🗣️

    • A comprehensive set of 250 audit questions to test your knowledge and prepare you for real-world GMP audits.

11. Conclusion 🚀

• Summarizing key takeaways from the course.
• Confidence building: How to apply your newfound knowledge in a GMP audit context.

Enroll today and embark on a journey to become an expert in Good Manufacturing Practices and GMP Audits. With this course, you'll have the tools and confidence to ensure that every pharmaceutical product meets the highest standards of quality. 🏅