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.
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
14:00 – 15:00 Data Integrity: Eliminating Risk & Human Error
in Our Manufacturing and Laboratory
Processes Mehul Patel, Global Director of
Training, Charles River
15:00 – 15:30 Tea Break
15:30 – 16:00 Fun Quiz on Data Integrity
"Are you confident with what you think you
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,
16:45 – 17:30 Data Integrity Gaps in Reality Kok Chia Phei, Senior CSV Consultant,
17:30 – 18:00 Panel Discussion Speakers
Computer System Validation (CSV) Best
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
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
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
- 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
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
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
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
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.
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 email@example.com to secure your participation:
Account Name: PDA Singapore Chapter
Account Number: 020-902240-4
Bank: DBS Bank
Bank Code: 7171
Branch Code: 020