PRNS Academy

Regulatory Training

Welcome to PRNS Academy: Your Gateway to Regulatory Excellence

At PRNS Academy, we understand the critical importance of regulatory compliance in today's complex and evolving business environment. Our comprehensive range of regulatory training programs is designed to equip professionals with the knowledge, skills, and expertise needed to navigate regulatory requirements, mitigate risks, and ensure compliance with laws, standards, and industry regulations.

Certification Process

Our Mission

Our mission at PRNS Academy is to empower professionals with the regulatory knowledge and expertise necessary to drive organizational success, protect stakeholders, and foster trust and confidence in regulatory compliance practices. We are committed to providing high-quality, practical training solutions that address the diverse needs and challenges of today's regulatory landscape.

We at PRNS ACADEMY offers following Regulatory trainings not limited to:

  • Awareness and Implementation MDR 2017 G.S.R 78 E
  • Performance Evaluation IVD
  • Risk Analysis ISO 14971:2019
  • Regulatory Orientation (Medical Devices)
  • CE Marking: MDR 2017-745. Medical Devices
  • CE Marking: MDR 2017-746. IVD
  • Medical Device Regulatory Fundamentals/ Regulatory Orientation
  • Medical Device Quality Management Systems (QMS) Implementation
  • Medical Device Risk Management Training: ISO 14971:2019
  • Medical Device Regulatory Submissions
  • Post-Market Surveillance and Vigilance
  • Medical Device Labeling and Packaging Compliance
  • Good Manufacturing Practices (GMP) for Medical Devices
  • Medical Device Auditing and Inspections
  • EU Medical Device Regulation (MDR) Training CE Marking: MDR 2017-745. Medical Devices/ CE Marking: MDR 2017-746. IVDs
  • FDA Medical Device Regulations Training
  • Clinical Evaluation and Clinical Trials for Medical Devices
  • QSR 21CFR Part 820

Ready to enhance your regulatory knowledge and expertise? Join us at PRNS Academy and embark on a journey of regulatory excellence. Explore our diverse range of training programs, connect with our expert instructors, and gain the skills and confidence needed to navigate the complex world of regulatory compliance.

Contact us today to learn more about our regulatory training programs and enrolment options. Let's work together to achieve regulatory compliance excellence and drive organizational success!

Regulatory Compliance

Operational Trainings- Awareness & Implementation

We at PRNS ACADEMY offers Awareness training is essential for educating employees and stakeholders about important topics, regulations, policies, or procedures within an organization. The goal of awareness training is to ensure that individuals understand their roles, responsibilities, and obligations in relation to specific subjects and to foster a culture of compliance, safety, and accountability.

  • Awareness and Implementation ISO 9001:2015
  • Awareness and Implementation ISO 13485:2016
  • Awareness and Implementation ICMED 9000 & ICMED 13485
  • Good Manufacturing Practice (GMP)
  • Good Documentation Practice (GDP)
  • Good Laboratory Practice (GLP)
  • Good Warehousing Practice (GWP)
  • Good Engineering Practice (GEP)
  • Concept of QA & QC
  • Calibration, Qualification & Validation
  • Clean Room Cleaning & Sanitization
  • Self-Inspection & Quality Audits
  • Vendor Qualification
  • Waste Control & Disposal
  • Environmental Monitoring
  • Identification and Traceability
  • Handling Non-conformances
  • Handling Deviations
  • Corrective Acton and Preventive Action
  • Handling, Storage, Packaging, Protection, Safety & Delivery of Material

Ready to take your career to the next level?

Contact us today to learn more about our training programs and enrollment options. Let's start this transformative journey together!

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