Participants will be introduced to the principles and methodology of air cleanliness classification in cleanrooms, the prerequisite and optional tests, changing room best practices with reference to the standard, implementation of the standard’s specified requirements during operation and an understanding of biocontamination, principals for its control and monitoring.
Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme Medical Device Single Audit Program (MDSAP) INTRODUCTION The Medical Device Single Audit Program (MDSAP) was the initiative from the International Medical Device Regulators Forum (IMDRF). Developed to enhance the…
Design of Experiments (DOE) is a systematic experimentation method. It is more efficient that the traditional experimentation methods such as the One-Factor-At-A-Time (OFAT) and Best Educated Guess. DOE employs statistic to model and optimize a process. It is widely used in process validation, parameter settings and developing a robust process
This course is designed for those with a working knowledge of medical device distribution practices and starts with a review of MDA/RR No.1. Participants will gain a broad understanding of Good Distribution Practice for Medical Devices (GDPMD) requirements together with associated regulatory requirements and guidance documents as well as internal audit methodology.
This interactive course engages the participants with in-depth discussion of industry best practices to learn how industry leaders address design control challenges.
The training provides the learner with a basic understanding of the principles and techniques of effective Root Cause Analysis and providing concepts needed to effectively perform investigation. The course is ideal for anyone who needs to understand the terminology and process of effective RCA.
This interactive course engages the participants with in-depth discussion of industry best practices to learn how industry leaders address design control challenges.
Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme Failure Modes, Effects and Criticality Analysis in Medical Device Manufacturing INTRODUCTION FMECA is a proactive risk assessment, quality and cost improvement method. It is useful in pre-empting failure risks,…
Understand the requirements of NCR, CAPA & Complaint Handling under ISO 13485:2016 QMS and US FDA Quality System Regulation (21 CFR Part 820)
This course provides regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA’s Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program.