Applying Baseline Guide 5 C&Q to a

Paperless Validation System

15 Oct 2020
 About ISPE

The International Society for Pharmaceutical Engineering is the world's largest not-for-profit
association serving its Members by leading scientific, technical and regulatory advancement throughout
the entire pharmaceutical lifecycle.

Mission Statement
ISPE is the global industry leader in connecting pharmaceutical knowledge to deliver manufacturing and
supply chain innovation, operational excellence and regulatory insights to enhance industry efforts to
develop, manufacture and reliably deliver quality medicines to patients.

Vision Statement
Provide solutions to complex pharmaceutical industry challenges through manufacturing innovation,
member and workforce development, technical, regulatory, and compliance collaboration.

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 Workshop Series
Hosted by:

Steam Sterilization & Autoclave Performance Qualification

20 Oct 2020 | 8-9.30pm | Online
• Sterilization microbiology
• Important elements of autoclave performance qualification
• Concept of using sterilization to control contamination - Biological indicators, chemical indicators and
sterilization wrapping

Cleaning Validation - Sterile Environments Regulatory Trends

10 Nov 2020 | 8-9.30pm | Online
• Current regulations, guidance and FDA expectations related to Cleaning Validation
• Review changes in draft Annex 1
• Review current findings from Regulatory inspections and identify trends relevant to Cleaning Validation
• Current industry perspective, trends, and best practices
• Where to focus attention for upcoming inspections - avoid scope creep
• Provide insight from her own experience and detail how to shore up your CV program and manage your
regulatory inspection

Connecting Pharmaceutical Knowledge ispe.org

 Upcoming Events

ISPE Singapore Quiz Night 2020

6 Nov 2020 | 5.30 – 6.30pm | Online

APAC Webinar: Work-Life-Balance/Confidence/Support

Network
12 Nov 2020 | 5 - 6.30pm | Online

Data Integrity (DI) and DI Management For Pharmaceuticals

17 Nov 2020 | 5.30 – 6.30pm | Online

Connecting Pharmaceutical Knowledge ispe.org

 www.ispesingapore.org
• 60+ sessions, virtual exhibition, roundtable sessions
• 3 days + pre-conference lead up events + post event access
• Regulatory compliance; Covid-19 scenarios; Digital pharma;
• Technology development; Quality & Compliance; DI & GAMP

Save SGD 100 with our Early Bird Rate! Available until 31 October 2020

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Thank you to our Sponsors:

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 About the speakers:

Sarah Grogan
Lead Process Engineer, Kneat Solutions, Ireland
Sarah is a Paperless Validation Subject-Matter-Expert, with
over 6 years' experience deploying and configuring paperless
validation solutions for some of the biggest life sciences
companies in the world. She has a background in Biomedical
Engineering and is currently based in Limerick, Ireland.

Pierre Winnepenninckx
CEO, No deviation, Singapore &
Conference Chair, ISPE Singapore Affiliate
Since starting his consultancy company in 2007, Pierre has
supported Commissioning and Qualification projects across
Asia, focussing on a risk based approach and ASTM2500E
guidance.
Active in ISPE since 2012, he played a leading role in the
design & qualification of process equipment at GSK Bio over
10 years. Pierre is from Belgium, where he gained his BSc in
Chemistry and Masters in Chemical Engineering.

Connecting Pharmaceutical Knowledge ispe.org