Risk Management Masterclass [2024] | Certification Course

🎓 Risk Management Masterclass [2024] | Certification Course by Anil Sharma Kandel

Course Headline: 🚀 Master the Art of Risk Assessment with ISO 14971 (RM) and ISO 13485 (QMS)

Course Overview:

Embark on a transformative journey into the world of risk management with our most extensive course on Risk Management available on Udemy. This comprehensive program is meticulously designed to elevate your expertise in both Risk Management and Quality Management System (QMS), particularly within the medical device, pharmaceutical industry, and beyond.

What You'll Learn:

• Foundational Knowledge: Gain a solid understanding of the principles and practices of ISO 14971 (Risk Management) and ISO 13485 (QMS), which are critical for any enterprise dealing with risk management activities.

• Expertise Development: Transform into a Subject Matter Expert (SME) in Risk Management and QMS by mastering complex risk assessment and risk measurement documentation techniques, such as PFMEA, DFMEA, HACCP, HAZOP, Benefit-Risk Analysis, Post Market Surveillance Report (PMSR), Clinical Effects Analysis Report (CEA).

• Global Standards Proficiency: Acquire a deep knowledge of international standards and regulations, including ISO 14971, ISO 13485, ISO 22000, 21CFR810 (FDA, USA), RDC 40/2015 (Anvisa, Brazil), EU 2017/745 MDR, MHLW MO 169 (PMDA, Japan), and TGR 2002 (TGA, Australia).

• Practical Application: Understand how to integrate processes like complaint reviews, Corrective and Preventative Maintenance (CAPA), Process Validation (PV), and Equipment Qualification (IQ/OQ/PQ) into your Risk Management framework.

• Career Advancement: Equip yourself with in-demand skills that will set you apart, making you a prime candidate for six-figure job opportunities in reputed medical device companies.

Who Is This Course For?

• Aspiring Risk Management professionals seeking to enter the field.
• Current QMS practitioners aiming to advance their careers.
• Anyone involved in the medical device or pharmaceutical industry who wants to deepen their understanding of risk management and quality systems.

Course Highlights:

• Global Relevance: This course is not limited to one region but applies worldwide, making you versed in international standards and regulations.

• Real-World Skills: Learn how to create Risk Assessment documents from scratch, a skill that is highly valued and sought after in the industry.

• Comprehensive Learning: From understanding risk management within the context of ERM to tying into Financial Risk Management (FRM), this course covers it all.

By the End of This Course, You Will Be:

• A pro at conducting Risk Assessment and Risk Measurement activities.
• Well versed in the rules, regulations, and standards that govern medical device industries globally.
• Capable of confidently discussing QMS and risk management standards in meetings, interviews, and with auditors.

Additional Notes:

• ERM Integration: This course is directly related to Enterprise Risk Management (ERM). It teaches you how to manage risks at the enterprise level, which includes medical devices and pharmaceuticals.

• FRM Benefits: For those interested in Financial Risk Management, this course offers valuable insights into various types of risks companies face, including financial risks.

Join Anil Sharma Kandel in this Risk Management Masterclass [2024] and take the first step towards becoming an industry-recognized expert in Risk Management and Quality Management Systems. 🌟