Invitation to Seminar

Agilent Pharma Day 2022 Malaysia

Details Date: Tuesday, 29 November 2022

Time: 08.30AM - 16.30 PM

Location: Sheraton Petaling Jaya Hotel, Lorong Utara C, Pjs 52, 46200 Petaling Jaya, Selangor

Agilent invites you to attend the Agilent Pharma Day Seminar in Malaysia Through years of innovation in science and technology, Agilent continues to build strong connections with our customers that use our state-of-the-art products and solutions. We are pleased to share our insights and would like to invite you to join us at the Agilent Pharma Day in Malaysia. Our experts will cover important topics on various Agilent’s solutions and how they can address the challenges that you face in your lab.

Presented by:

Register Now Lim Teck Maan Application Scientist

Bernard Tan Lab Informatics Regional Product Specialist

www.agilent.com This information is subject to change without notice.  © Agilent Technologies, Inc. 2022 Published in SAPK, November, 2022

Udi Jumhawan LCMS Application Scientist

Lee, Yoke Hwei Regional Applications Scientist

Sanath Varma, SAJK Regional Compliance Specialist

Lin Yuan LC AE Supervisor

Ralf Davidsson SLIMS Product Specialist SAJK Region

Chow Mee Ling Spectroscopy Product Specialist

Robin Philp Academia & Collaborations Manager

Agenda 8:30 a.m - 9:00 a.m

Registration

9:00 a.m - 9:10 a.m

Opening & Welcome Yan Kah Leng, Malaysia Country Sales Manager, Agilent Technologies Malaysia

9:10 a.m - 9:55 a.m

Modernizing Workflow - Preparing for the New USP Updates on "Allowable Adjustments" for Chromatography Lim Teck Maan, Application Scientist, Agilent Technologies Malaysia

Synopsis  9:55 a.m - 10:25 a.m 10:25 a.m - 10:50 a.m Synopsis 

10.50 a.m - 11.15 a.m Synopsis 

Keep the lab up to date with the updates on on Allowable Adjustments Chromatographic Conditions with modernized instrument and workflow. Column Chemistries Lee, Yoke Hwei, Regional Applications Scientist, Agilent Technologies Malaysia Compliance and Efficiency Improvement with a Fully Digital End-to-End Workflow in SLIMS Ralf Davidsson, SLIMS Product Specialist SAJK Region, Agilent Technologies Australia 1) Understand the importance of a digital workflow to track the entire sample workflow and guide lab staff in following SOPs correctly 2) Understand the impact on efficiency that a lab execution system has got compared to manual workflows based on spreadsheets and paper Features in OpenLab Software Suite to Help Meet Your Data Integrity Requirements Bernard Tan, Lab Informatics Regional Product Specialist, Agilent Technologies Singapore 1) Why care about data integrity? 2) What is Data Integrity 3) Common Data Integrity Issues 4) Capabilities in OpenLab to help you achieve data integrity

11:15 a.m - 11:30 a.m

Coffee Break

11:30 a.m - 12:20 p.m

Computerized System Validation and Agilent’s Compliance Consultancy Services Sanath Varma, SAJK Regional Compliance Specialist, Agilent Technologies Singapore

Synopsis 

Computer System Validation (CSV) is a regulatory requirement for all computerized systems used in regulated environments in the Pharmaceutical, Biotech, Nutraceutical, and Medical Device industries. CSV ensures that computerized systems are performing properly according to customer intended uses and regulatory requirements, such as: • US FDA - 21 CFR Parts 210/211, EudraLex - Volume 4 - GMP guidelines, PIC/S Guide to GMP • 21 CFR Part 11 & EudraLex and PIC/S Annex 11

12:20 p.m - 12:50 p.m Synopsis 

Supporting Pharmaceutical Laboratories with USP-ICH Elemental Impurities Testing Chow Mee Ling, Spectroscopy Product Specialist, Agilent Technologies Malaysia Workflow solution from samples preparation to analysis results and reporting.

12:50 p.m - 14:00 p.m

Lunch

14:00 p.m - 14:30 p.m

Agilent Solutions for Genotoxic Impurities Analysis Udi Jumhawan, LCMS Application Scientist, Agilent Technologies Singapore

Synopsis 

14:30 p.m - 15:00 p.m Synopsis 

1) Understand what mutagenic impurities are and why it's important to characterize and quantify them, even when present in trace amounts 2) Understand how Agilent solutions comply with the current regulatory guidelines for nitrosamines analysis in drug substance Agilent Solutions for Extractable and Leachable Analysis Udi Jumhawan, LCMS Application Scientist, Agilent Technologies Singapore 1) Understand the definition, concern, diversity and challenges of E&L analysis 2) Understand how Agilent solutions enable confident identification and quantitation of potential E&Ls from extracts derived from a variety contact closure system components and packaging materials

Agenda 15:00 p.m - 15:30 p.m Synopsis  15:30 p.m - 16:15 p.m Synopsis  16:15 p.m - 16:30 p.m

Next Generation Bio LC for Biopharma Applications Lin Yuan, LC AE Supervisor, Agilent Technologies Singapore Agilent offers comprehensive solutions to address the growing complexity of biopharma analysis work flow. This presentation introduces how Agilent Bio LC helps you to overcome challenges you may encounter during various biopharma analysis. New Frontiers in Biomolecule Characterization Robin Philp, Academia & Collaborations Manager, South East Asia, Agilent Technologies Malaysia This presentation will cover a brief overview of Agilent’s biopharma portfolio as well as a focus on the new BioConfirm software that is now industry compliant. Q & A Session & Coffee Break

Presenters Modernizing Workflow - Preparing for the New USP Updates on "Allowable Adjustments" for Chromatography Lim Teck Maan, Application Scientist, Agilent Technologies Malaysia Teck Maan joined Malaysia Agilent Customer Service Organization in 2011 as an Application Customer Engineer specializing in Agilent liquid phase and mass spectrometry products. He provided instrument services, customer trainings and application methods setup and consultations. He recently joined Technical Sales Team as a liquid phase Application Scientist working on new application deve lopments and product demonstration covering SMT-IDO region. He also has an industry focus in Pharma market.

Column Chemistries Lee, Yoke Hwei, Regional Applications Scientist, Agilent Technologies Malaysia Yoke Hwei is the Applications Scientist who supporting the Agilent Chemistries and Supplies Division for nearly 15 years. She is providing application solution for the customers in South Asia Pacific, ANZ and Korea. She graduated with Master in Analytical Chemistry & Pharmaceutical Science from Loughborough University UK. Then, she was working as R&D Chemist in the Commercial Laboratory and doing method transfer from Canada who responsible for the method validation and regulatory compliance. With over 20 years research and work experience covering a wide range of applications based on LCMS and GCMS, her focus is food, pharmaceutical and clinical analysis in recent years.

Compliance and Efficiency Improvement with a Fully Digital End-to-End Workflow in SLIMS Ralf Davidsson, SLIMS Product Specialist SAJK Region, Agilent Technologies Australia Ralf Davidsson is a Lab informatics product specialist and business developer at Agilent Technologies. Having spent 16 years with Agilent, he works closely with customers and the Agilent teams to create the right informatics solutions addressing customer needs. Ralf has a MSc in Chemical Engineering and has previously worked 4 years in the pharmaceutical industry as a lab engineer.

Features in OpenLab Software Suite to Help Meet Your Data Integrity Requirements Bernard Tan, Lab Informatics Regional Product Specialist, Agilent Technologies Singapore Bernard is a Lab Informatics Product Specialist in Agilent. He has over 15 years of Lab Informatics experience, dealing with a full spectrum of Lab Informatics products from Lab Information Management System (LIMS) to Chromatography Data System (CDS) for analytical instrumentation control. In his current role at Agilent, he supports the Southeast Asia region in providing customers from various industries with suitable informatics solution for their current and future laboratory needs.

Computerized System Validation and Agilent’s Compliance Consultancy Services Sanath Varma, SAJK Regional Compliance Specialist, Agilent Technologies Singapore Sanath is based in Singapore. He has worked in the Pharmaceutical, Biopharmaceutical, Dietary Supplements, and Life Sciences industries for the past 15 years. Half of those years were spent working as a consultant performing CSV activities in the regulated environments of the Pharma and Biopharma industries. He has worked on a variety of Data Integrity remediation projects, as well as Laboratory IT projects. The other half of his career has been spent working as an Analytical Chemist in GMP environments – performing analytical method validation and QC analysis of samples across all stages of production.z

Supporting Pharmaceutical Laboratories with USP-ICH Elemental Impurities Testing Chow Mee Ling, Spectroscopy Product Specialist, Agilent Technologies Malaysia Ms. Chow graduated with Master of Philosophy (Chemistry) in University of Malaya. Currently she is taking responsible as Spectroscopy Product Specialist in Agilent Technologies (Malaysia) Sdn Bhd. She also delivers technical expertise for molecular and atomic spectroscopy solution implementation to the customer based on application, method development and technical support.

Presenters Agilent Solutions for Genotoxic Impurities Analysis & Agilent Solutions for Extractable and Leachable Analysis Udi Jumhawan, LCMS Application Scientist, Agilent Technologies Singapore Udi is applications scientist for LCMS at Agilent Technologies Singapore. He has more than 6 years of experience in biopharma, clinical, forensic and toxicology and food safety applications. Udi holds a PhD in Biotechnology from Osaka University, Japan.

Next Generation Bio LC for Biopharma Applications Lin Yuan, LC AE Supervisor, Agilent Technologies Singapore Lin Yuan supervises LC application scientist team to support the Agilent LC business covering Singapore and the ASEAN region. She holds a MSc in Organic Chemistry from National University of Singapore. Lin Yuan has over 10 years of experience in liquid chromatography, and 6 years of professional experience in the pharma and food industry. She has conducted many trainings, workshops and seminars for customers on HPLC and GPC.

New Frontiers in Biomolecule Characterization Robin Philp, Academia & Collaborations Manager, South East Asia, Agilent Technologies Malaysia With a background in biochemistry Robin worked at the Imperial Cancer Research Fund and the Ludwig Institute for Cancer Research in London in protein biochemistry before moving to Oxford GlycoSciences. Following that he moved to Singapore where he ran the department of Proteomics at A*STAR’s Bioprocessing Technology Institute under the directorship of Prof. Miranda Yap. In 2008 he joined Agilent Technologies in Singapore as a specialist in mass spectrometry and now acts as the Academia & Collaborations Manager for Singapore, Malaysia and Thailand based in Kuala Lumpur.