Kelly Thomas
Join us for an insightful session on the critical topic of Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products. This course provides essential knowledge for professionals involved in the pharmaceutical industry, specifically focusing on the storage and transportation of both finished and investigational drug products.
Key Highlights:
1. Understanding Drug Product Risks: Explore the potential risks associated with the storage and transportation of pharmaceutical products, including temperature fluctuations, contamination, and security concerns.
2. Regulatory Compliance: Learn about the latest regulatory requirements and guidelines for drug product storage and transportation to ensure compliance with international standards.
3. Risk Assessment: Gain practical knowledge of conducting risk assessments specific to your organization's drug product supply chain.
4. Mitigation Strategies: Discover effective strategies to mitigate risks and safeguard drug product quality and patient safety.
5. Investigational Drug Products: Special focus on the unique challenges and considerations when handling investigational drug products.
6. Best Practices: Learn industry best practices and case studies illustrating successful approaches to drug product storage and transportation.
Why Attend?
Who Should Attend?
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes, and cleaning validation. Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
