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15 - 16 JULY 2019 JASMINE SEMINAR ROOM, N22 IBD, UTM JOHOR BAHRU course introduction This course is for those with HPLC basic knowledge and interested to learn more about HPLC method development, validation and basic troubleshooting. High performance liquid chromatography is used for sepa- rating components in a mixture. The basic principles in all chromatographic methods require one static part (stationary phase) and one moving part (the mobile phase). HPLC provides users with robust yet flexible method depend- ing on the user’s target compound to be separated. This training will be delivered by our experienced and well- trained analysts in the laboratory. Students, researchers and laboratory technicians are encouraged to join the course to learn a comprehensive HPLC method development, method validation and basic troubleshooting. The objective of this workshop is to provide participants with theoretical knowledge on HPLC Method Development and Method validation as a requirement for ISO 17025:2017. To equip participants on how to troubleshoot daily issues on HPLC course objectives www.ibd.utm.my INSTITUTE OF BIOPRODUCT DEVELOPMENT, UNIVERSITI TEKNOLOGI MALAYSIA enquiries Jalan Sultan Yahya Petra, 54100 Kuala Lumpur tel : +603.2615 4406 Attn : Yatie email : [email protected] 81310 UTM Johor Bahru, Johor tel : +607.553 1559 Attn : Asmafarhana email : [email protected] course content METHOD DEVELOPMENT, METHOD VALIDATION AND BASIC TROUBLESHOOTING FOR HPLC Method Development and Method validation Introduction to ICH guidelines: ICH Q2 Introduction to ISO17025:2017 Instrument overview Selecting HPLC separation mode Selecting the most appropriate detector Selecting the column & mobile phase Method Validation Type of analytical procedure to be validated Validation of chromatographic methods A 2 Day Course on Parameter to be validated Acceptance criteria Validation procedures and protocols Basic HPLC Troubleshooting and maintenance - Peak resolution - Retention time - Hardware maintenance Institute of Bioproduct Development

A 2 Day Course on METHOD DEVELOPMENT, METHOD VALIDATION AND BASIC TROUBLESHOOTING … · 2019. 3. 1. · Basic HPLC Troubleshooting and maintenance - Peak resolution - Retention time

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  • 15 - 16 JULY 2019JASMINE SEMINAR ROOM, N22 IBD, UTM JOHOR BAHRU

    course introductionThis course is for those with HPLC basic knowledge and interested to learn more about HPLC method development, validation and basic troubleshooting. High performance liquid chromatography is used for sepa-rating components in a mixture. The basic principles in all chromatographic methods require one static part (stationary phase) and one moving part (the mobile phase). HPLC provides users with robust yet flexible method depend-ing on the user’s target compound to be separated.This training will be delivered by our experienced and well-trained analysts in the laboratory. Students, researchers and laboratory technicians are encouraged to join the course to learn a comprehensive HPLC method development, method validation and basic troubleshooting.

    ● The objective of this workshop is to provide participants with theoretical knowledge on HPLC Method Development and Method validation as a requirement for ISO 17025:2017.● To equip participants on how to troubleshoot daily issues on HPLC

    course objectives

    www.ibd.utm.myINSTITUTE OF BIOPRODUCT DEVELOPMENT, UNIVERSITI TEKNOLOGI MALAYSIAenquiries

    Jalan Sultan Yahya Petra, 54100 Kuala Lumpurtel : +603.2615 4406 Attn : Yatie email : [email protected]

    81310 UTM Johor Bahru, Johortel : +607.553 1559 Attn : Asmafarhana email : [email protected]

    course content

    METHOD DEVELOPMENT, METHOD VALIDATION AND BASIC TROUBLESHOOTINGFOR HPLC

    Method Development and Method validation• Introduction to ICH guidelines: ICH Q2• Introduction to ISO17025:2017

    Instrument overviewSelecting HPLC separation mode Selecting the most appropriate detector Selecting the column & mobile phase

    Method Validation• Type of analytical procedure to be validated • Validation of chromatographic methods

    A 2 Day Course on

    • Parameter to be validated • Acceptance criteria • Validation procedures and protocols

    Basic HPLC Troubleshooting and maintenance - Peak resolution- Retention time - Hardware maintenance

    Institute ofBioproduct Development

  • Fee is inclusive of lunch, refreshments and course materials.

    Accommodation is not included.

    Local Participant RM 650

    course fee

    course tutors

    YES! I would like to register the following participants

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    15 - 16 July 2019 : Jasmine Seminar Room, N22, IBD UTM Johor

    A3 : A 2 Day Course on Method Development, Method Validation andBasic Troubleshooting for HPLC

    Account name Bendahari UTM Bank CIMB Bank Berhad Account No 8006053536

    Method of Payment

    Cancellation & Substitutions

    A) The organiser has the right to make any amendments that they deem to be in the best interest of the course and to cancel the course if insufficient registrations are received a week before course commencements date.

    B) CERTIFICATE OF ATTENDANCE will be awarded at the end of the course.

    A full refund will be promptly made for all written cancellations 2 weeks before the course. 50% refund will be made for written cancellations received 7 days before the course. A substitute may be made at any time.Note

    Please kindly complete and return thereply form together with : By cheque / Bank Draft which are madepayable to BENDAHARI UTMPayment direct to account

    Assoc. Prof. Dr. Chua Lee Suan has com-pleted her PhD in 2005 from Universiti Teknologi Malaysia. She is a registered chemist, university lecturer and Quality Manager for SAMM ISO/IEC 17025 Biofertilizer Laboratory (SAMM N0: 433). Her expertise in natural products, particularly for metabolite profiling of herbs and honey and has published more than 50 interna-tional research articles and serving as editor for repute journals such as Journal of Ginseng Research and European Journal of Me-dicinal Plants.

    ASSOC. PROF DRCHUA LEE SUAN

    MRS. SITI HAJARBTE MAT SARIP

    Siti Hajar bte Mat Sarip is a Research Officer for the past 10 years in Institute Bioproduct Devel-opment (IBD) under Analytical & Biovalidation unit and previously she has been working in Soil, Water & Biofertilizer Laboratory unit and in Biore-sources unit. She also appointed as a Deputy Quality Manager and Technical Manager in IBD Laboratory Services to maintained accredited laboratory as ISO 17025 require-ments and now she appointed as Head of Analytical & Biovalidation unit since 2016. She has completed MSc. In Bioprocess Engineering at Universiti Teknologi Malaysia related to deliv-ery system for pesticide ingredients. His exper-tise is related to ISO/IEC 17025 system and analytical laboratory.

    She is currently a Research Officer in Institute of Bioproduct Development, Universiti Teknologi Malaysia. She has 6 years of experience working in analyti-cal laboratory and research. She has developed skills and expertise in performing analysis, data interpreta-tion and operation & maintenance on multiple lab equipment; Mass Spec-trometer, HPLC, GC, IC and AAS. She served as a Scientist in R&D Analytical Department of Biocon Sdn Bhd, a renowned biopharmaceutical manu-facturing company. Over the years, she has helped in efforts to obtain regulatory approvals for insulins and derivatives now commercially avail-able locally and globally. She used to work as a Research Officer in NIH Secretariat, Ministry of Health Malaysia doing research management and ethical approval. Nurul Azwa obtained her BSc Biotech-nology (2009) and Master of Biotech-nology (2014) from Universiti Malaya. Her master dissertation was on Biopro-cess Technology, focusing on optimi-zation of biohydrogen production from several types of waste. She is a certified Halal Executive, Safety and Health Officer and GCP. Nurul Azwa has worked in cGMP, GDP and GLP facilities and well-versed with ISO 14001, ISO 17025 and OHSAS 18001.

    NURUL AZWA MOHD YUNUS