Regulatory Requirement

Course Objective:

  • Overview of the FDA and intention of the 21 CFR Part 820 Quality System Regulation (QSR)
  • To understand the up-to-date requirements of 21 CFR Part 820 QSR and other Parts such as Part 11, Part 803 and Part 821
  • Working knowledge in application of the requirements
  • Preparation for FDA inspection

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Course Objective:

  • Understanding the GDPMD requirements
  • Awareness on the key elements to ensure medical device quality and safety along the supply chain.
  • Understanding on the certification process
Duration: 1 day or 2 days Suitable for: This course is designed for the employees from all the function/levels whom would

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Course Objective:

  • General requirements for Process Validation
  • The linkage of the Process Validation with the standards and regulatory requirements
  • Step-by-step on performing the Process Validation
  • Hands on experience to develop Process Validation documentation
Duration: 2 days Suitable for: This course i

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Course Objective:

  • Understanding of Scheduled Wastes
  • Understanding of the Scheduled Wastes Regulations and relevant guidelines in Malaysia
  • Understanding of the practical way to meet the Scheduled Wastes Regulations requirements.
Duration: 1 day Suitable for: This course is designed for the employees from all the func

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Course Objective:

  • Understanding of the GDPMD requirements
  • Understanding the audit principles
  • Plan, conduct, report and close out an internal audit
Duration: 1 day or 2 days Suitable for: This course is designed for those employees are appointed/potentially appointed as internal auditors, and those who would like to

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Course Objective:

  • General requirements for Software Validation
  • The linkage of the Software Validation with the standards and regulatory requirements
  • Step-by-step on performing the Software Validation.
  • Hands on experience to develop Software Validation documentation
Duration: 1 day Suitable for: Any person

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Course Objective:

  • Understanding what is medical devices
  • Understanding of the Malaysian Medical Devices Law
Duration: 1 day Suitable for: This course is designed for the employees from all the function/levels whom would like to gain understanding on the Medical Device Law in Malaysia, including those from the organizations that are currently certified t

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Course Highlight: This course provides an overview of the requirements on the Environmental Quality Act and the related regulations (such as Scheduled Waste Regulation, Industrial Effluent Regulation etc.)
  Duration: 1 day
  Suitable for: Any person that would like to gain some general knowledge on the Environmental Laws in Malayisa.
  Contact us for t


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