Gain the knowledge you need on regulatory requirements in drug applications, sterile manufacturing, root cause investigations, quality and compliance management for virtual companies, cybersecurity risk management, and change management.
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.
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 an Investigation Roadmap, and electronic templates to guide you through the methodology and provide the basis for documentation.
Global Regulatory and CGMPs for Sterile Manufacturing
Through case studies, lectures, and engaging activities, you will build a toolbox approach to working on and solving actual company CGMP problems in sterile manufacturing.
Quality and Compliance Management for Virtual Companies
This training course explains the GMP, GCP, and GLP responsibilities of virtual companies or others that predominately outsource GxP-governed activities. Know what you need to have in place, identify the high-risk areas, and understand how to manage those risks as your company grows.
Cybersecurity Risk Management for Drug Delivery Combination Products
Gain an understanding of cybersecurity risk management principles with comparison to safety risk management. Walk through methods and associated tools to identify, assess, and control cybersecurity risks using drug delivery combination product examples. You will also interact directly with FDA on questions related to drug delivery combination product cybersecurity.
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 and change control procedures, and gain an understanding of why it's necessary to involve various disciplines within the company in the process.
Visit pdatraining.org for a complete list of PDA training courses.
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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