April 22, 2024 | US Eastern Time: 10 AM to 4 PM | Central Europe Time: 4 PM to 10 PM
This course offers comprehensive training on classifying medical products as drugs, medical devices, or combination products, emphasizing precision and risk assessment. Participants will gain a deep understanding of regulatory frameworks, including FDA and EMA regulations, and learn to apply key classification criteria such as primary mode of action, intended use, and structural characteristics. Through interactive exercises, case studies, and real-world examples, participants will develop practical skills in accurately classifying products and conducting effective risk assessments. By mastering these essential concepts, participants will enhance regulatory compliance, streamline product development processes, and mitigate risks, ultimately contributing to the safe and successful commercialization of medical products.
WHY YOU SHOULD ATTEND:
This course is essential for professionals involved in the development, regulatory compliance, and commercialization of medical products. By attending this training, participants will gain a comprehensive understanding of regulatory frameworks, classification criteria, and risk assessment principles crucial for navigating the complex regulatory landscape effectively. Understanding the distinctions between drugs, medical devices, and combination products is vital for determining the appropriate regulatory pathway and ensuring compliance with regulatory requirements set forth by agencies such as the FDA and EMA. Additionally, precise classification and thorough risk assessment are paramount for ensuring the safety, efficacy, and quality of medical products, ultimately safeguarding patient health and minimizing regulatory risks. By mastering these key concepts and skills, participants can contribute to the successful development, approval, and commercialization of medical products, while also enhancing regulatory compliance and mitigating potential risks associated with product development and marketing. Attendees will benefit from practical insights, interactive exercises, and real-world case studies, enabling them to apply learned principles effectively in their roles and organizations.
Overall, the training provides a comprehensive overview of product classification and risk assessment, equipping participants with the knowledge and skills necessary for regulatory compliance and successful product development.
WHO SHOULD ATTEND:
Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.