This training is designed for Quality and Regulatory Managers/Supervisors, Product Designers, Management Representatives, Internal Auditors and Consultants.
Training input will consist of practical knowledge, role plays, case studies and self-revealing instruments and questionnaires. Learning will be enhanced through active involvement; individual and group exercises followed by review. Opportunities for self-assessment will be provided and feedback on individual and group performance will be encouraged. Participants will work on their own individual team issues during the program.
Module 1: Introduction to Quality Management System
Module 2: Overview of ISO 13485:2016 requirements
Module 3: Comparisons between ISO 13485:2016 and ISO 13485:2003 requirements
Module 4: Audit planning and preparation
Module 5: Audit execution
Module 6: Non-conformity reporting
Module 7: Closing meeting
Module 8: Audit report preparation
Module 9: Audit follow-up
4.5
Mr Anwar is a Registered as Conformity Assessment Body for Medical Device Authority (MDA). He has been almost 20 years in Pharmaceutical industry. He completed his degree in Bac. Pharmaceutical from UNIVERSITI SAINS MALAYSIA In 1985 and Matriculation Program earlier in the same University.
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