COURSE AIM
To have a clear understanding of international regulatory authority regulations and gain the background knowledge to effectively plan on method validation for the chemical testing.
ENTRY REQUIREMENT
This course is recommended for those interested in and currently working in chemical testing laboratories, especially for technician / chemist who is performing the method validation for new development testing method, operations manager, professional and technical staff, quality manager, internal auditor, authorized representatives and approved signatory.
COURSE CONTENT
Method Validation:
Introduction and Essential statistics
- General ISO/IEC 17025 & HOKLAS requirement
- Significance testing (hypothesis testing)
- Analysis of variance
- Type of Quality Control chart
Essential Tools
- Introduction to the concepts of method validation
- Performance parameters I: precision, bias and ruggedness.
- Performance parameters II: selectivity, instrument detection limit, method detection limit, limit of quantitation, linearity and working range.
- Use of precision and accuracy control charts.
LEARNING OUTCOME
- identify the difference between verification and validation
- justify the validation parameters required to evaluate whether the method is fit for intended use.
EMERGING TECHNOLOGIES
Method validation is the essential process and an evidence-based approach for the new developed method to provide the evidence on the “fit for intended use”. Several parameters are assessed with different criteria within specific guidance. The method validation report is often to be assessed during the accreditation process.
REMARK
- After completion of all TLM1, TLM3, TLM5 & TLM6, he or she is eligible for applying Professional Certicate of Laboratory Technical Officer.
- After completion of all TLM1, TLM3, TLM4, he or she is eligible for applying Professional Certicate of Laboratory Auditor.
CERTIFCATE AND CPD:
Certificate of successful Completion will be awarded delegates who have attended full course. An e-Certificate will only be granted. You may be able to claim CPD hours for your membership at professional bodies.
** RTTP (Reindustrialisation and Technology Training Progamme) Recognized Training Course **
RTTP Pre-approval training courses, eligible company could apply for RTTP funding in order to receive up to 2/3 course fee reimbursement for each employee.
Coupon:
Available
