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PDA Singapore Chapter Data Integrity and Computer System Validation Symposium

Aug 28 - Aug 28, 2018 |
Aug 28, 2018 |
NTU Alumni House | Marina Square, Singapore
  • Chapter
  • Asia-Pacific
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August 28, 2018, 12:00 – 18:00

NTU Alumni House
6 Raffles Boulevard #02-27/28
Marina Square, Singapore 039594

PDA Singapore Chapter, together with Charles River Laboratories as our Platinum Sponsor, is pleased to invite you to participate in our Data Integrity and Computer System Validation (DI and CSV) Symposium on 28 August 2018. This is our flagship symposium that the Singapore Chapter hold every year to address the hot topics in the pharmaceutical industry. With the symposium, you would be able to engage with colleagues in the industry including academia, industry players and regulators.

Agenda

The speakers will present us various topics on CSV and DI covering both laboratory and manufacturing system. We will also look into Data Integrity maturity assessment and the actual DI gaps in reality. Hence, do not miss this golden opportunity to hear from them and network with your peers.

12:00 – 13:00 Registration and Lunch
13:00 – 14:00 Computer System Validation (CSV) Best Practice Isara Isarowong, Director QA, Novartis Pharmaceuticals
14:00 – 15:00 Data Integrity: Eliminating Risk & Human Error in Our Manufacturing and Laboratory Processes Mehul Patel, Global Director of Training, Charles River Laboratories
15:00 – 15:30 Tea Break
15:30 – 16:00 Fun Quiz on Data Integrity "Are you confident with what you think you know?" Bruce Loxley, Senior Manager - Audit I&TPO, GSK Vaccine
16:00 – 16:45 Data Integrity in Manufacturing and Lab Systems – Expectations of Auditors Thomas Halfmann, Managing Partner, HGP
16:45 – 17:30 Data Integrity Gaps in Reality Kok Chia Phei, Senior CSV Consultant, Visentic Solution
17:30 – 18:00 Panel Discussion Speakers

Abstracts

Computer System Validation (CSV) Best Practice
How can an organization design, implement and validate/qualify the computerized system not only for compliance, but also for competitive advantage? This brief session of knowledge sharing and discussions is intended for experience professional and will include topics related to risk-based qualification/validation of on-premise and clouds computing models. Mr. Isarowong will be sharing his computer validation/qualification approaches and strategies to keep your operation operating effectively, efficiently and in compliance in this fast moving world.

Data Integrity: Eliminating Risk & Human Error in Our Manufacturing and Laboratory Processes
The human element can never be completely eliminated, but what can be done to mitigate the risk for human error and how does human error relate to the data integrity problem? Through this talk, we will seek to answer this question. As our thinking on data integrity within the industry has evolved, lapses have been brought to the forefront by regulatory agencies citing violations and inadequacies in findings from inspections, audits, and warning letters. There are two main pillars that link data integrity compliance to our industry; software and electronic data compliance, and our risk mitigation strategies for human error. Taking a step back and looking critically at our current processes and methods, we begin to realize that a majority of these methods are considered antiquated in the face of how our quality systems and manufacturing processes have evolved over time. Taking a deeper dive into each process, reveals that these methods rely heavily on the human factor to provide an accurate recordable result. Research from many industries shows that mitigating the risk for human error is not related to our analysts lacking the knowledge, skill, or the ability to perform the task. But rather, correcting the processes that allow for errors to occur in the first place.

Reducing the risk for human error in our manufacturing and laboratory processes will ensure that we comply with data integrity laws and regulations while building quality into our everyday processes and keeping our patients and our drugs safe. As laboratory testing shifts from observation-based qualitative methods to less subjective quantitative methods, focus on data integrity becomes more critical to ensure overall product quality and patient safety. This presentation will provide guidance and demonstrate to our industry that:

  • Utilizing an organized, risk-based approach to closing human error gaps in our processes allows us to prove to all stakeholders that the data we use to determine product quality is integral and accurate.
  • Examining real-world examples from the industry will allow for the evaluation of their own processes for unnecessary data integrity and human error risks.
  • Automation will increasingly play an important role in reducing a laboratory's risk to human error and data integrity violations in the future.

Data Integrity in Manufacturing and Lab Systems – Expectations of Auditors
For the last few years data integrity is an increasing concern with regulatory inspectors. The demand for data integrity in itself has been long-standing: the paper-based manufacturing documentation has always been subject to review, and that surely has not changed since electronic data acquisition came about. What is really new about the topic, in particular, is the increasing complexity of state-of-the-art IT solutions and automation infrastructure. In this presentation we will discuss

  • what guidelines in regards of data integrity require
  • what the expectations of auditors are in regards of data integrity in manufacturing and laboratories
  • data integrity considerations for manufacturing IT systems
  • how to conduct a data integrity maturity assessment.

Data Integrity Gaps in Reality
Regulatory guidance has included many DI scenarios and good practices, this session shares DI gaps in reality across medical, biologics & R&D setup.

About the Speakers

Isara Isarowong, Director QA Novartis Pharmaceuticals
Currently, Isara is a Director of Global Compliance and Auditing at Novartis Pharmaceuticals, Inc. His 25 years of experience includes Audit and Compliance, Quality Assurance Operations, Regulatory Compliance, Manufacturing Support, Process Design, Technology Transfer, New Product Launch, Medical Device Design (IVD), Facility Renovation/ Recertification, Capital Equipment and Instrument Installation/Qualification, Process Validation, Plant Automation and Modernization, Cost Reduction and Capacity Expansion. His quality/regulatory experience includes GMP, GLP and GCP auditing (SaaS/SaaP vendors, suppliers, CROs, Investigator Sites, and Laboratories/Reading Centers), Deviation Investigation (NC, OOS), CAPA, Quality System Design and Quality Assurance.

He is currently leading the Novartis global DI program verification audits. He conducted several Advance CSV Workshops in Brazil, Singapore, Malaysia, Indonesia and India. He co-leads the PDA DI Subgroup (Mid-West PDA Chapter, USA).

Mehul Patel, Global Director of Training Charles River Laboratories About the speaker:
Mr. Mehul Patel received his Bachelor of Science degree in cellular and molecular biology from the University of Michigan and his Master of Business Administration in finance from the University of Delaware. Mehul has over 18 years of extensive pharmaceutical and biotechnology industry experience in proteomic R&D, laboratory automation, product development and technical marketing. Currently he is the Global Director of Training for Charles River's Microbial Solutions division and is responsible for developing and implementing global strategies in support of corporate initiatives.

Thomas Halfmann, Managing Partner HGP About the speaker:
Thomas Halfmann is founder and managing partner of HGP. HGP is a healthcare industry consulting company with offices in Switzerland, Germany, Poland and Singapore. Before founding HGP, Thomas was Global Head Biopharmaceutical Operations IT and Head of the Global MES Program, both at Novartis. Since February 2018 Thomas is appointed as Operations Director of the OPEN -SCS (Serialization Communications Standard) working group. Thomas is an expert in paperless manufacturing, serialization, business process analysis and modelling, project management, quality management, and computer system validation with more than 20 years of experience in the healthcare industry.

Kok Chia Phei (CP), Senior CSV Consultant Visentic Solutions About the speaker:
With respect to Data Integrity (DI), CP is formally trained in 2016 by GMQA, conducted DI audit in 2017 and rolled out DI compliance in 2018.

CP has participated in CSV since 1998 covering manufacturing system (DCS, SCADA, PLC, MES, BMS), laboratory system, study management system etc.

Formally trained and worked as a control engineer, CP's current professional interest includes Quality Metrics, Cybersecurity, Database, etc.

Registration

The fee for participation (including lunch and a tea break) is:

  • Early Bird before 31-July-2018: SGD 100.00 (member) and SGD 120.00 (non-member)
  • Normal price: SGD 120.00 (member) and SGD 150.00 (non-member)
  • Regulators, students and academia are able to join at Member price.

For payment, please transfer to the following account and send your transfer detail to pda.sg.chapter@gmail.com to secure your participation:

Account Name: PDA Singapore Chapter
Account Number: 020-902240-4
Bank: DBS Bank
Bank Code: 7171
Branch Code: 020

Register Now
mailto:pda.sg.chapter@gmail.com?subject= DI and CSV Chapter Event Registration

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