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September 2020

Modular Construction in Biopharma Manufacturing Facilities​

Modular Construction in Biopharma Manufacturing Facilities​   With advancements manufacturing technology, facility design can now be highly modularized to facilitate process flexibility, scalability and repurposability. This PDA Midwest Event will focus on Modular Construction and On-Demand Cleanrooms as it relates to Biopharma Manufacturing, with an exploration into evolution, design, validation, and regulatory compliance.   Presentation Date and Time: September 10, 2020 @ 11:00 am (central time zone)   Presentations by: Maik Jornitz, G-Con Manufacturing Inc.​ Ravi Samavedam, Azzur Group  …

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October 2020

Serialization and the Battle Against Pharmaceutical Counterfeiting

Serialization and the Battle Against Pharmaceutical Counterfeiting As pharmaceutical counterfeiting continues to grow, Serialization is one of our greatest tools to help patients guarantee they are receiving the high-quality safe medicine they desire. This PDA Midwest Event will focus on Serialization and its part in the global concern of pharmaceutical counterfeiting, the regulator environment Serialization exists in and other business value added beyond compliance.   Presentation Date and Time: October 7, 2020 @ 11:00 am (central time zone)   Presentation…

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December 2020

Pharmaceutical Inspection Observations and Mitigations

Pharmaceutical Inspection Observations and Mitigation The PDA Midwest Chapter is pleased to present a great topic for our December 2020 event to focus on recent FDA 483 observations and corrective actions. Special considerations will be given to how these observations and regulations relate to USP 797 and GMPs. Please join us for a live presentation including a Q&A session with our experienced industry expert. Presentation Date and Time: December 9, 2020 @ 11:00 am (central time zone)   Presentation by:…

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January 2021

Developing a Sampling Plan for USP Compliance

Developing a Sampling Plan for USP <797> Compliance The PDA Midwest Chapter is pleased to present a great topic for our January 13th, 2021 event to focus on USP <797> facilities. USP General Chapter <797> has required viable air and surface sampling since 2008. Many organizations have their certification provider perform this sampling, which means the certification provider also choses the sample locations. This results in sample locations that are not risk-based or do not provide valuable information on the…

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Unique Device Identification (UDI)

Unique Device Identification (UDI) The implementation of Unique Device Identification (UDI) can enhance patient safety and improve efficiency in the healthcare supply chain. The system is designed to clearly identify medical devices from manufacturing through distribution to patient use.  This session will introduce the viewer to the on-package UDI requirements, and both serialized and non-serialized approaches to meeting these requirements.  This will include message set-up, vision inspection and overall data management. Presentation Date and Time: January 27, 2021 @ 11:00…

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February 2021

Don’t Wait for “Them” to Find Your Weaknesses

Don't Wait for "Them" to Find Your Weaknesses The PDA Midwest Chapter is pleased to present a great topic for our February 2021 event to focus on audit preparation. Hosting an audit whether it is a Client or a Regulatory inspection can be very stressful. It can be even more stressful if you are not prepared. The following presentation will focus on preparing for audits through the use of gap assessment, internal audits and best practices of hosting audits. We…

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Parametric Release for Moist Heat Sterilization

Parametric Release for Moist Heat Sterilization The PDA Midwest Chapter is pleased to present a great topic for our February 2021 event, the history and advantages to Parametric Release for products terminally sterilized by moist heat. Presentation Date and Time: February 24, 2021 @ 11:00 am (central time zone)   Presentation by: Eric Peryer is currently a Senior Manager, Research leading the Sterility Assurance team in Baxter’s Medication Delivery business unit.  Current responsibilities include supporting terminal sterilization for new product…

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March 2021

A Case Study on Low Endotoxin Recovery in mAb Based Products

A Case Study on Low Endotoxin Recovery in mAb Based Products The PDA Midwest Chapter is pleased to present a great topic for our March 2021 event. Low endotoxin recovery (LER) or endotoxin masking received a lot of attention from the FDA in particular Patricia Hughes in 2016, after the presentation by Chen and Vinter at the PDA Annual meeting. The concern is that “low endotoxin recovery is not assessed and or protocol report is not submitted” for NDA or…

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How Documented and Recognized Operational Excellence Drives Improved Audit Results: Sponsored by Contec, Inc.

This webinar will give a brief overview of the top three awards for operational excellence, the Malcolm Baldridge Award, AME Excellence Award and Shingo Prize along with a discussion of how Shingo award recipients have improved audit results. In addition, this webinar will provide an overview of an anecdotal case study currently in development as a precursor to further independent scholarly research into a larger data set regarding this topic. Presentation Date and Time: March 24, 2021 @ 11:00 am…

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April 2021

PDA Midwest and Missouri Valley Chapters Present Diverse Leadership in Life Sciences – Sponsored by PSC Biotech

Diverse Leadership in Life Sciences The PDA Midwest and Missouri Valley Chapters are pleased to cohost this two hour special webinar, highlighting a round-robin, moderated panel discussion addressing a range of current industry topics from remote audits and cell and gene therapy regulatory compliance to personal challenges in the work place and current realities of working in a COVID-19 era. This event will be moderated by Jim Polarine, Senior Technical Service Manager at STERIS Corporation. This panel consists of leaders within…

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