Agenda

Day 1
Monday, 30 September 2019
  • 0900 - 1100
    Opening Plenary Session
    This plenary session will focus on three important regulatory topics, including PIC/S GMP Inspection Reliance Initiative and the benefits that this will bring to industry, the importance of having robust Quality Risk Management systems in place and the importance of maintaining high levels of quality culture vigilance.
    Session Leaders
    ISPE Singapore President
    Speakers
    Deputy Director (Overseas Audit) / Deputy Head(GMP) / Senior GMP Auditor
    Health Science Authority
    Director, Division of Drug Quality I
    FDA/CDER/OC/OMQ
    Expert GMDP Inspector
    MHRA
    AP Regulatory Affairs Advisor
    ISPE
    Presentation Information
    [PIC/S GMP Inspection Reliance Initiative]
    Speaker: Meow Hoe Boon
    || [Quality Risk Management and Inspectional Findings in the Global Environment ]
    Speaker: Carmelo Rosa
    || [Quality Culture and Inspectional Findings]
    Speaker: David Churchward
  • 1130 - 1300
    Cleaning Validation and Process Validation
    This session will focus on the quality and compliance requirements for an effective cleaning validation program. This session will also include Regulatory requirements and the latest up to date industry practices. Attendees will be able to obtain an FDA Regulator's perspectives on cleaning validation and areas of concern during regulatory inspections.
    Session Leaders
    Director, Division of Drug Quality I
    FDA/CDER/OC/OMQ
    Speakers
    Compliance Officer
    FDA/CDER
    Compliance Officer
    FDA/CDER
    President
    Mindful Quality
    President and CEO
    Novatek International
    Principal/Director
    New Wayz Consulting Ltd
    Presentation Information
    [Recent Inspectional Trends on Cleaning Validation/Cross-Contamination Issues]
    Speaker: Frank Verni
    || [Understanding the Compliance Risks with Cleaning Validation and Campaign Changeover ]
    Speaker: Jennifer Carlson
    The key to successful defending your cleaning validation program during a health agency inspection is understanding your compliance risks. We will discuss how to identify and remediate risks within your cleaning validation program and campaign changeover activities.
    || [URS & Implementation of Risk Based Cleaning Validation Management System]
    Speaker: Parsa Famili
    || [Process Validation ]
    Speaker: Maurice Parlane
  • 1400 - 1530
    Facilities of the Future: An Exploration of Pharma
    The ISPE Facilities of the Future Initiative will explore what pharmaceutical manufacturing facilities will look like in the future. The key trends are Pharma 4.0 and continuous manufacturing to help the pharmaceutical industry overcome the obstacles to digitalization and lead to paradigm changes for pharmaceutical manufacturing linking Industry 4.0 to Pharma and the global ICH regulatory guidelines by designing an Operating Model according to the ICH Holistic Control Strategy. This session provides the ISPE activities and decision-making perspective on continuous manufacturing.
    Session Leaders
    Senior Regulatory CMC Adviser
    Bayer Yakuhin Ltd
    Speakers
    Senior Director Global Accounts
    Werum IT Solutions
    Associate Professor
    The University of Tokyo, Department of Chemical Systems Engineering, Invited
    Head of Regional Engineering Japan / Global Engineering / Global Manufacturing &
    TAKEDA PHARMACEUTICAL CO., LTD.
    Presentation Information
    [From Industrie 4.0 to Pharma 4.0 Operating Model and the Holistic Control Strategy ]
    Speaker: Christian Woelbeling
    || [Continuous Manufacturing from Decision-Making Perspective ]
    Speaker: Hirokazu Sugiyama
    || [Pharma Society 5.0 Driven by ISPE Japan]
    Speaker: Hirokazu Kisaka
    As a Facility of the Future activity, ISPE is developing a future picture of drug manufacturing and exploring its directions. In such development, the ISPE Headquarters announced Pharma 4. 0 as a future image of the pharmaceutical industry in response to Industry 4. 0, which was announced by the German government. The Japanese Government also announced "Society 5. 0" as a form of a super-smart community. ISPE Japan Affiliate is trying to draw "Pharma Society 5. 0" as a way of manufacturing pharmaceuticals in a super smart society as a whole. This presentation shows the outline, the process of discussion and examination.
  • 1615 - 1800
    Effective CAPA - Unmasking the Reality of Out-of-Specifications (OOS) Investigations
    Why are regulatory inspectors still finding problems in Out-of-Specifications (OOS) investigations? Discussion of real examples will help you and your company to understand the difference between root cause analysis and CAPA. Learn how to establish a reliable and sustainable quality system.
    Session Leaders
    Compliance Officer
    FDA/CDER
    Speakers
    Acting Quality Assessment Lead
    FDA/CDER/OPQ/OPF
    Compliance Officer
    FDA/CDER
    Compliance Officer
    FDA/CDER
    Placeholder Person Graphic
    Regulatory Officer/Food Drug Regulation Officer III
    Food & Drug Administration Philippines
    Founder & Principal
    BioPharm Excel Ltd.
    Presentation Information
    [Understanding the Materiality Concept in Out-of-Specifications Results Obtained from Pilot/Pre-Approval Batches ]
    Speaker: Aditi Thakur
    || [Understanding Regulatory Expectations: A Deep Dive into the FDA Out-of-Specifications Guidance ]
    Speaker: Frank Verni
    || [Philippines FDA journey towards PIC/S accession]
    Speaker: Pia Rose Belarmino
    || [Measuring What Matters: Understanding the Importance of Establishing Meaningful CAPA, OOS and IOOS Metrics to drive Operational Excellence in your Laboratory]
    Speaker: Nuala Calnan
    This session will share insights from the St. Gallen / FDA Quality Metrics research and discuss the business benefits of a adopting a proactive approach to managing and maintaining Operational Excellence within the QC Laboratory environment.
Day 2
Tuesday, 1 October 2019
  • 0900 - 1100
    Asia Pacific Regulatory Updates
    This session will focus on regulatory updates across the Asia Pacific, including an update on the ASEAN Mutual Recognition Agreement on GMP Inspections, WHO's approach and experience with Prequalification GMP inspections in India and China, The Philippines FDA journey towards PIC/S accession and the PMDA's efforts to establish a training centre for GMP inspectors in Asia Pacific.
    Session Leaders
    AP Regulatory Affairs Advisor
    ISPE
    Speakers
    Director, Quality Assurance
    Health Sciences Authority of Singapore
    Technical Officer
    World Health Organization
    Presentation Information
    [Asian Training Centre in Japan and how it helps in the Training of GMP inspectors in Asia Pacific Session]
    Speaker: Nobumasa Nakashima
    In line with the objectives of the PMDA International Strategic Plan 2015 that specifies international activities the agency should implement by 2023, in April 2016, PMDA established the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC). The mission of the PMDA-ATC is to promote greater understanding of internationally accepted regulations pertaining to pharmaceuticals and medical devices among regulatory authorities in Asian and other countries. PMDA-ATC provides training courses including the GMP inspection seminar taking place mainly in the Hokuriku branch office that was established in June 2016. The themes of PMDA-ATC GMP inspection seminar were solid dosage form in FY2016, vaccine in FY2017, and API for biotech from in FY2018. In this year FY2019, PMDA-ATC GMP Inspection Seminar’s program consists of PMDA-ATC original session and PIC/S seminar on “Quality Assurance of Sterile Medicinal Products” hosted by MHLW/PMDA.
    || [ASEAN Harmonization on Pharmaceutical Inspections: Benefits to the ASEAN Economic Community ]
    Speaker: Sia Chong Hock
    This presentation will cover the implementation of a pan-ASEAN Mutual Recognition Agreement (MRA) on pharmaceutical inspections, and its benefits to the ASEAN Economic Community. I will also elaborate on the future developments and collaborations between ASEAN and its Asian neighbours as well as the wider global pharmaceutical community.
    || [WHO experience in Prequalification GMP inspections in India and China]
    Speaker: Vimal Sachdeva
  • 1130 - 1245
    Data Integrity Across Manufacturing
    Data integrity is the essential foundation to safeguarding product quality and patient safety, but it can be challenging to achieve and maintain integrity across the diversity and complexity of manufacturing data. This session will provide practical approaches to understanding and mitigating data integrity risks for manufacturing data (based on the new ISPE GAMP RDI Good Practice Guide on Data Integrity for Manufacturing Records), followed by a case study sharing real-life experiences of implementing and safeguarding data integrity within a regulated company.
    Session Leaders
    President & CEO
    Lachman Consultant Services, Inc
    Speakers
    Director, Division of Drug Quality I
    FDA/CDER/OC/OMQ
    VP Global Quality
    Mylan
    Founder & Principal
    BioPharm Excel Ltd.
    Regional CSV Consultant
    Waters Corporation
    Presentation Information
    [Data In Manufacturing ]
    Speaker: Reem Maliki
    || [Process Validation Controls and Impact on Data ]
    Speaker: Nuala Calnan
    || [Data Integrity for Manufacturing ]
    Speaker: Charlie Wakeham
  • 1330 - 1500
    Aseptic Processing
    This session will provide a current overview of the aseptic environment and the most common deficiencies regulators are finding and regulatory expectations for remediation.
    Session Leaders
    Compliance Officer
    FDA/CDER
    Speakers
    Compliance Officer
    FDA/CDER
    Director Operation Quality, QA Audit and Compliance
    AbbVie
    Qualified Person
    Commissioning Agents, Inc
    Presentation Information
    [Regulatory Trends in Aseptic Process Inspections: Case Studies]
    Speaker: Frank Verni
    || [Regulatory Expectations in Aseptic Processing: Review of Recent Findings]
    Speaker: Andrew Hopkins
    Andrew will cover expectations for regulatory inspection of aseptic processing and some of the more contentious issues such as PUPSIT that were discussed in the draft Annex 1, and he will also discuss some of the recent findings linked to Aseptic processing and give some background to these findings.
    || [The Disposition Process for Batches with Personnel & Environmental Deviations]
    Speaker: John Henchion
    Batches manufactured using Aseptic practices have extensive associated Environmental and Personnel Monitoring. On occasion, the monitoring generates a result that fails specification. What are the processes, that can be applied during the batch disposition, to determine the potential impact to batch sterility that ultimately feeds into the batch disposition decision?
  • 1545 - 1700
    Closing Plenary Session - US, EU and PIC/S GMP Inspections
    Engage in open dialogue with a panel of seasoned regulatory experts. Gain insight into inspection approaches among regulators around the world and recent collaboration efforts. Explore how PIC/S and other agencies facilitate and encourage that collaboration.
    Session Leaders
    President & CEO
    Lachman Consultant Services, Inc
    Speakers
    Acting Quality Assessment Lead
    FDA/CDER/OPQ/OPF
    ISPE Singapore President
    Compliance Officer
    FDA/CDER
    Deputy Director (Overseas Audit) / Deputy Head(GMP) / Senior GMP Auditor
    Health Science Authority
    Placeholder Person Graphic
    Regulatory Officer/Food Drug Regulation Officer III
    Food & Drug Administration Philippines
    Director, Division of Drug Quality I
    FDA/CDER/OC/OMQ
    Presentation Information
    [Closing Remarks]
    Speaker: Joseph Micsko
    || [Regulatory Collaboration Around the World]
    Speaker: Carmelo Rosa
After the Event
2 October - 3 October 2019
  • 0830 - 1700
    GMP Fundamentals for the Pharmaceutical Industry Training Course- Separate Registration Required
    This 2-day classroom course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process.

    Training Course Schedule

    0830-1000 Classroom Training
    1000-1030 Refreshment Break
    1030-1200 Classroom Training
    1200-1300 Lunch
    1430-1500 Refreshment Break
    1500-1700 Classroom Training
    Speakers
    Acting Quality Assessment Lead
    FDA/CDER/OPQ/OPF
    Compliance Officer
    FDA/CDER
    Director, Division of Drug Quality I
    FDA/CDER/OC/OMQ