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He serves on a number of scientific and professional advisory boards and holds a Bachelor's degree from MIT and a Master's degree from the University of California, Berkeley, both in Chemical Engineering. Stephen Born, Ph.D., Director of Scientific Affairs, CONTINUUS Pharmaceuticals, Inc. Full biography coming soon! WHO SHOULD ATTEND THIS WEBINAR:

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Design & Validation of Isolator Systems for the Manufacturer and Testing of Health Care Products, PDA, Technical Report Number 34, pub. 2001. Aseptic Pharmaceutical Manufacturing, published 1987 by Interpharm Press. ISPE Baseline Pharmaceutical Engineering Guide, Volume 3, Sterile Manufacturing Facilities, Jan. 1999.

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Foreword 4 4 Acknowledgements 6 6 Table of Contents 7 7 1 Introduction 9 9 1.1 Foundation for the Good Practice Guide 10 10 1.2 Global Acceptance/Authorization 11 11 1.3 Scope 14 14 1.4 Purpose 14 14 1.5 Benefits 15 15 2 Basic Terms Used in the Process Validation Lifecycle 17 17 2.1 Process Validation Lifecycle Stages 17 17 2.2 Stage 1 Process …

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Introduction. Pharmacoepidemiologic studies provide valuable information about the health effects of healthcare products. The ISPE Guidelines for Good Pharmacoepidemiology Practice (GPP) are intended to assist investigators with issues pertaining to the planning, conduct, and interpretation of pharmacoepidemiologic research.

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2022 ISPE Facilities of the Future Conference. The 2022 ISPE Facilities of the Future Conference will explore advancements in pharmaceutical technology and what pharmaceutical manufacturing facilities will look like in the future. Featuring technical and inspirational presentations from industry leaders already planning and building “facilities of the future” this conference will look …

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Updated: 8 hours ago

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(813) 960-2105

If you need additional assistance, please contact our Member Services Team by email at [email protected] or by phone at (813) 960-2105.

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Exhibits & Sponsorships The 2022 ISPE Facilities of the Future Conference attendees will explore advancements in pharmaceutical technology and what pharmaceutical manufacturing facilities will look like in the future. Exhibiting or sponsoring at this event provides an opportunity to engage with industry leaders in an environment dedicated to the networking and the sharing of ideas.

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To meet the goals identified by USFDA above, there are a number of accepted methods and/or practices that can be used. This includes consensus guides such as ASTM E2500-13, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical manufacturing systems and Equipment, industry guidance such as ISPE’s ...

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+1 317.657.4194

Each bottle is individually printed with a lot number, unique serial number and expiration date for enhanced process control and traceability. ... Phone +352.26.33.731 +1 317.657.4194 ... ISPE Singapore; 1020 Flynn Road Camarillo, CA 93012. 1230 Calle Suerte Camarillo, ...

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Updated: 7 hours ago

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