The Process Analytical Technology & Lifecycle Control Strategy Community of Practice has been working hard to have a more diverse community membership and a more diverse leadership representation on our steering committee. We are happy to gain the insights, knowledge and ideas from a growing group of women leaders in our Community of Practice steering committee: Line Lundsberg as current chair and three new members; Melanie Dumary, Elisabeth Peeters and Elena Vulpe. In addition, Elisabeth and Elena bring key experience and a critical voice to the table as Emerging Leaders – another group essential to our growth and continued success as a community and industry.
Our women leaders also #ChooseToChallenge outside of our own community. Emerging challenges like globalization, supply chain complexity, costs and price in pharmaceutical industry have been amplified by the COVID-19 pandemic, further driving the need for the industry to embrace the Pharma 4.0 transformation and move into the new Digital Era. Line Lundsberg, our chair of the Process Analytical Technology & Lifecycle Control Strategy Community of Practice, in collaboration with other women leaders Nuha Al-Hafez, Theresa Allyn, Yvonne M. Duckworth, and male colleagues, Robert W. Landertinger Forero, Lothar Hartmann, Daniel J. Roberts, Joost Van Den Broeck and Thomas Zimmer from the Pharma 4.0 COP, tackled these challenges in the March/April issue of Pharmaceutical Engineering’s featured article "Holistic Control Strategy: From ICH Quality Guideline to Pharma 4.0 ". This strategic approach incorporates GMP and Good Distribution Practices (GDP), and defines the controls from a holistic perspective that will ensure product quality and clinical performance, product availability, and product improvement.
One area we are looking to combine the opinions and know-how from our community and the Emerging Leaders is through a Roundtable Webinar targeted for this summertime. This Roundtable will be led by our Women Emerging Leaders with other SMEs from our Community of Practice, and will have 3 main goals: 1) to share the current Process Analytical Technology & Lifecycle Control Strategy Community of Practice Business Overview for the remainder of 2021 including our focus areas, 2) to engage the community on a hot topic, such as Control Strategies (more detail coming) while gaining perspectives specifically from our Emerging Leaders in our community, and 3) to go in dialogue with our community on the topics; ask and answer questions, drive into detail, and brainstorm future webinar topics.
In addition, future educational presentations on Demystifying the Control Strategy are currently being proposed for future ISPE conferences. Once again, these are sessions led by women in our Community of Practice as well as our women Emerging Leaders.
Please look for these exciting topics to engage with our women leadership within our Community of Practice, and our Emerging Leaders. With this leadership team we look to leverage what we have accomplished in the first three months of 2021, and carry it throughout the rest of 2021…on heels 😊.
Looking forward to seeing you virtually or in person!
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