Medical Devices; ISO 13485; MDSAP; CE Marking EU MDR 2017/745; US 21CFR820 QSR & Regulations; Malaysia GDPMD, MDA’s Establishment License & Device Registration; Cosmetic GMP; and other QMS.
Email: sarc.periti@gmail.com
| 1000197062 | |
| NPRA's Cosmetic GMP Guideline | |
| Cosmetic Products in Malaysia are regulated under the Control of Drugs & Cosmetic Regulations 1994. All cosmetic products must be manufactured in accordance with the Guideline for Cosmetic GMP or its equivalent. This program aims to provide participants with an overview of the regulatory control of cosmetic products in Malaysia and an understanding of the NPRA’s GMP Guideline. | |
| 7 Hours (1 Day) | |
| Managers, Key Staffs, Supervisors, Internal Auditors. | |
| English | |
| Bahasa and Mandarin |
| English | |
| Bahasa and Mandarin |
| 1000168606 | |
| Good Distribution Practice for Medical Devices (GDPMD) | |
| The GDPMD specifies the Good Distribution Practice for Establishments placing medical device on the Malaysian market. This course is designed to provide participants with the practical knowledge to ensure the safety and performance of the medical device at point of use. By the end of this course, participants will understand, apply and comply with the GDPMD. |
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| 7 Hours (1 Day) | |
| Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in GDPMD. | |
| English | |
| Bahasa and Mandarin |
| 1000168607 | |
| ISO 9001:2015 Internal Audit | |
| This course is designed to provide participants with the practical knowledge, audit skills, and gain confidence to conduct audit through live audit experience. By the end of this course, participants will be competent to conduct internal audit on the QMS for conformance to the ISO 9001:2015 and applicable regulatory requirements. |
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| 14 Hours (2 Days) | |
| Internal Auditors, Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in Internal Audit. | |
| English | |
| Bahasa and Mandarin |
| 1000166932 | |
| ISO 9001:2015 QMS Requirements | |
| The ISO 9001:2015 requirements are generic and intended to be applicable to any organization, regardless of its type, size, products and services offer. This course is designed to provide participants with the practical knowledge to understand the requirements. By the end of this course, participants will understand, apply and comply with the ISO 9001:2015 requirements. |
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| 7 Hours (1 Day) | |
| Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is in implementation of ISO 9001:2015. | |
| English | |
| Bahasa and Mandarin |
| 1000184201 | |
| MDSAP - Internal Audit | |
| This course is designed to provide participants with the practical knowledge, audit skills, and gain confidence to conduct internal audit (MDSAP Model) through live audit experience. By the end of this course, participants will be competent to conduct internal audit on the medical devices QMS and applicable regulatory requirements in accordance to the Medical Device Single Audit Program (MDSAP). |
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| 14 Hours (2 Days) | |
| Internal Auditors, Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in Internal Audit. | |
| English | |
| Bahasa and Mandarin |
| 1000184201 | |
| MDSAP - Internal Audit | |
| This course is designed to provide participants with the practical knowledge, audit skills, and gain confidence to conduct internal audit (MDSAP Model) through live audit experience. By the end of this course, participants will be competent to conduct internal audit on the medical devices QMS and applicable regulatory requirements in accordance to the Medical Device Single Audit Program (MDSAP). |
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| 14 Hours (2 Days) | |
| Internal Auditors, Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in Internal Audit. | |
| English | |
| Bahasa and Mandarin |
| 1000155045 | |
| ISO 13485:2016 Internal Audit | |
| This course is designed to provide participants with the practical knowledge, audit skills, and gain confidence to conduct audit through live audit experience. By the end of this course, participants will be competent to conduct internal audit on the medical devices QMS for conformance to the ISO 13485:2016 and applicable regulatory requirements. |
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| 14 Hours (2 Days) | |
| Internal Auditors, Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in Internal Audit. | |
| English | |
| Bahasa and Mandarin |
| English | |
| Bahasa and Mandarin |
| 1000168606 | |
| Good Distribution Practice for Medical Devices (GDPMD) | |
| The GDPMD specifies the Good Distribution Practice for Establishments placing medical device on the Malaysian market. This course is designed to provide participants with the practical knowledge to ensure the safety and performance of the medical device at point of use. By the end of this course, participants will understand, apply and comply with the GDPMD. |
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| 7 Hours (1 Day) | |
| Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in GDPMD. | |
| English | |
| Bahasa and Mandarin |
| 1000169149 | |
| Understanding the Requirements of MDSAP (Medical Devices Single Audit Program) | |
| This course is designed to provide participants with the practical knowledge to understand the MDSAP requirements. By the end of this course, participants will be able to understand the MDSAP requirements, the Audit Model & Sequence and the details Audit Tasks (for the primary MDSAP processes and the supporting processes). |
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| 14 Hours (2 Days) | |
| Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in Medical Devices Single Audit Program. | |
| English | |
| Bahasa and Mandarin |
| English | |
| Bahasa and Mandarin |
| English | |
| Bahasa and Mandarin |
| 1000156854 | |
| CE Marking of Class I Medical Devices - EU MDR 2017/745 | |
This course is designed to provide participants with the practical knowledge to comply with the Regulation (EU) 2017/745 on Medical Devices. By the end of this course, participants will:
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| 7 Hours (1 Day) | |
| Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in CE Marking of medical devices. | |
| English | |
| Bahasa and Mandarin |
| 1000169145 | |
| Fundamental & Practices of Process Validation | |
This course is designed to provide participants a systematic approach and the practical knowledge to carry process validation. By the end of this course, participants will be able to:
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| 7 Hours (1 Day) | |
| Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in validation of production process. | |
| English | |
| Bahasa and Mandarin |
| 1000184100 | |
| ISO 14971:2019 Risk Management | |
| This course is designed to provide participants with the practical knowledge and skills to identify hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of the controls are in placed. By the end of this course, participants will be able to manage risks associated with the medical device in accordance to ISO 14971:2019. |
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| 7 Hours (1 Day) | |
| Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in risk management of medical devices. | |
| English | |
| Bahasa and Mandarin |
| 1000168654 | |
| ISO 9001:2015 Risk-based Thinking | |
| The ISO 9001:2015 require companies to continual align the QMS with the Strategic Direction and Organization Context in order for the company’s QMS remain relevant. This course is designed to provide participants with the practical knowledge to apply risk management process in the context of ISO 9001:2015. By the end of this course, participants will be able to manage the risks & opportunities within the scope of the QMS and organizational context in a systematic manner. |
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| 7 Hours (1 Day) | |
| Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is involve in risk management of ISO 9001:2015. | |
| English | |
| Bahasa and Mandarin |
| 1000185439 | |
| ISO 13485:2016 QMS Requirements | |
| This course is designed to provide participants with the awareness of the ISO 13485:2016 throughout the product life cycle of a medical device, with emphasize on the applicable regulatory requirements. Having completed this course, participants will gain the knowledge of ISO 13485:2016 and aware of the applicable regulatory requirements of a medical device. |
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| 7 Hours (1 Day) | |
| Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is responsible implementation of the medical devices QMS. | |
| English | |
| Bahasa and Mandarin |
| 1000155042 | |
| Understanding the Requirements of ISO 13485:2016 | |
| This course is designed to provide participants with the practical knowledge to interpret and apply the ISO 13485 requirements throughout the product life cycle of a medical device and comply with the applicable regulatory requirements. By the end of this course, participants will:
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| 14 Hours (2 Days) | |
| Managers, Engineers, Internal Auditors, Supervisors, Key staffs and anyone who is responsible implementation of the medical devices QMS. | |
| English | |
| Bahasa and Mandarin |
| 1000196863 | |
| Cosmetic GMP Internal Auditor | |
| This course is designed to provide participants with the practical knowledge and audit skills to conduct audit on NPRA's or ISO 22716 Cosmetic GMP Guideline. By the end of this course, participants will be competent to conduct internal audit on the QMS for conformance to the NPRA’s or ISO 22716 Cosmetic GMP Guideline. | |
| 7 Hours (1 Day) | |
| Internal Auditors, Responsible Person, Managers, Key Staffs, Supervisors. | |
| English | |
| Bahasa and Mandarin |
| English | |
| Bahasa and Mandarin |
