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Following the 2019 PDA/FDA Joint Regulatory Conference, dive into the regulatory details with your choice of six training courses!
Choose from training courses on CMC regulatory requirements in drug applications, sterile manufacturing, root cause investigations, quality and compliance management for virtual companies, cybersecurity risk management, and change management. |
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CMC Regulatory Requirements in Drug Applications
Be prepared to better address the key points required in the CMC sections of drug applications! Gain a more thorough understanding of the requirements in new drug applications, abbreviated new drug applications, post-approval change supplements, and more. |
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Root Cause Investigation for CAPA
Learn a seven-step root cause investigation methodology, apply the concepts to case studies, and come away with the ability to immediately, effectively, and efficiently apply the methodology to identify root causes and restore performance, saving time, resources, and reputation. You will be provided with a Roadmap, electronic templates, and tools that act as a basis for documentation. |
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Quality and Compliance Management for Virtual Companies
This training course explains the GMP, GCP, and GLP responsibilities of virtual companies or others who predominately outsource GxP-governed activities. Know what you need to have in place, identify the high-risk areas, and understand how to manage those risk as your company grows. |
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Change Management - A Practical Workshop
Do you know everything that goes into a proper change management program? In this training course, learn about change control review requirements and common pitfalls, change control procedures, and gain an understanding of why it's necessary to involve various disciplines within the company. |
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PDA is an accredited provider of continuing education, offering high-quality, relevant training for both new and experienced professionals working in industry, government (health authority), and academia.
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