ISPE

AUGUST 3, 2023

Member Spotlight: Tracy Jamerson Trudy Patterson Thu, 08/03/2023 - 15:37 iSpeak Blog iSpeak Member Spotlight: Tracy Jamerson Edyna Miguez 3 August 2023 Tracy Jamerson is the Chapter Manager for the ISPE Midwest Chapter. Here’s what she has to say: When and why did you get involved with ISPE?

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ISPE

FEBRUARY 13, 2023

Bob came to ISPE in 2004, furthering an already distinguished career in the pharmaceutical industry and as a regulator. After having worked in industry as a senior Quality Assurance position he joined the Therapeutic Goods Administration (TGA), Australia in 1971 as a GMP inspector. ISPE presented Bob with the Joseph X.

Documentation 98

Documentation FDA 98

ISPE

SEPTEMBER 13, 2023

Logan Thomas Wed, 09/13/2023 - 11:09 iSpeak Blog iSpeak Meet the 2023 Foya Supply Chain and Social Impact Categories Winner: SERUM Institute of India Pvt. They were able to mobilize those resources to modify already constructed buildings without needing support from external engineering and construction agencies.

Vaccines 98

Vaccines 98

ISPE

NOVEMBER 30, 2022

iSpeak Blog. As one of the founders of Cheme Engineering, Nik Krpan was instrumental in the start-up of the company. I love chemical engineering as a discipline because you have so many different ways you can go with it including water. ISPE Communities of Practice Leaders – Nik Krpan. Trudy Patterson. Wed, 11/30/2022 - 11:07.

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Dosage Documentation Compounding 52

ISPE

SEPTEMBER 5, 2023

Trudy Patterson Tue, 09/05/2023 - 10:42 iSpeak Blog iSpeak Meet the 2023 FOYA Innovation Category Winner: Chugai Pharma Manufacturing Co., Chugai Pharmaceutical Co. All Lines are fully compliant with global GMPs and are capable of manufacturing high potency pharmaceutical ingredients, which had been difficult to do.

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ISPE

MARCH 7, 2023

Mentor ISPE Launches for All Genders Trudy Patterson Tue, 03/07/2023 - 11:30 iSpeak Blog iSpeak Mentor ISPE Launches for All Genders Carolina Isabel Serrano Martinez 7 March 2023 Arriving in the United States at the age of 17 to pursue my dreams was one of the greatest challenges of my life.

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ISPE

OCTOBER 26, 2022

iSpeak Blog. During this 90-minute session, complementary industry perspectives from equipment/autonomous facilities providers and biopharmaceutical manufacturers will be respectively provided by Dennis Powers, Vice President, Business Development & Design Consulting, G-CON and Richard Panton, Principal Engineer, Roche/Genentech.

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FDA 52

ISPE

SEPTEMBER 28, 2023

Navigating Life Sciences Construction in California Trudy Patterson Thu, 09/28/2023 - 11:40 iSpeak Blog iSpeak Navigating Life Sciences Construction in California Gul Dusi 28 September 2023 Few industries have as deep a footprint in California, USA as life sciences. billion a year.

Hospitals 98

Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 98

ISPE

SEPTEMBER 7, 2023

Numerous pharmaceutical companies are diversifying their portfolios, while some are taking a leap into the ATMP (Advanced Therapy Medicinal Product) era. supply chain management, pharmaceutical quality system, and so on). Advanced Technology to deliver medicines faster, cheaper, and with enhanced quality.

Hospitals 98

Hospitals Pharmaceutical Companies Pharmaceutical Companies 98

ISPE

SEPTEMBER 21, 2023

Join the First Discussion after the 25 August Effective Date Trudy Patterson Thu, 09/21/2023 - 08:38 iSpeak Blog iSpeak Annex 1 in Force! Annex 1 in Force! Join the First Discussion after the 25 August Effective Date Richard Denk Matthew P. ™ and Annex 1 Conference couldn’t be better. What Will Be Most Valuable to Attendees?

Documentation 98

Documentation FDA 98

ISPE

APRIL 12, 2023

A Closer Look at Paperless Validation’s Impact on Biotech Trudy Patterson Wed, 04/12/2023 - 07:34 iSpeak Blog iSpeak A Closer Look at Paperless Validation’s Impact on Biotech Steven Thompson 12 April 2023 The impact of paperless validation on the biotechnology industry is massive, and the overall effect is growing as adoption increases.

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Documentation FDA 98

ISPE

SEPTEMBER 12, 2023

Empowered by Community; A Mentor ISPE Experience Trudy Patterson Tue, 09/12/2023 - 08:23 iSpeak Blog iSpeak Empowered by Community; A Mentor ISPE Experience Amy Washco 12 September 2023 As a mid-career employee, I’ve earned expertise in many areas but feel I still have much to learn. More importantly, I feel have much left to offer.

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Pharmaceutical Companies Pharmaceutical Companies Vaccines 52

ISPE

OCTOBER 28, 2022

“Membrane-based water for injection is a state-of-the-art method that should be used whenever possible,” said Good Practice Guide (GPG) Co-lead Fritz Roeder, Global Engineering Manager, Merck Healthcare KGaA. Learn More & Purchase. Meet the ISPE Staff: Tim Postlethwaite. Meet Tim Postlethwaite, Director of Technical Communities.

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Documentation 52

ISPE

FEBRUARY 7, 2023

Hartman noted the importance of attendees’ work in bringing pharmaceuticals to patients. The contributions of the pharmaceutical industry—and appreciation for those—has been another lesson learned, Hepburn said. Initiatives in the pharmaceutical industry include the NIIMBL consortium. We really need solutions,” he said.

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Vaccines Dosage Hospitals 88

ISPE

FEBRUARY 27, 2023

Tapping into emotional intelligence, sustainability, and the importance of embracing diversity, equity, and inclusion, Women in Pharma programming continues to drive the group’s vision for a more equitable pharmaceutical industry, where diversity of thought thrives. Learn More & Get Involved Women in Pharma

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ISPE

FEBRUARY 27, 2023

Tapping into emotional intelligence, sustainability, and the importance of embracing diversity, equity, and inclusion, Women in Pharma programming continues to drive the group’s vision for a more equitable pharmaceutical industry, where diversity of thought thrives. Learn More & Get Involved Women in Pharma

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ISPE

SEPTEMBER 8, 2023

This article outlines ISPE task teams created reports and a model to examine the challenges surrounding drug shortages, emergency preparedness, and the supply chain of active pharmaceutical ingredients (APIs). This article outlines these initiatives. This article outlines these initiatives.

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Documentation 91

ISPE

JULY 20, 2023

The Europe Hackathon Inspires Creative Solutions to Real-World Challenges Trudy Patterson Thu, 07/20/2023 - 10:53 iSpeak Blog iSpeak The Europe Hackathon Inspires Creative Solutions to Real-World Challenges Zam Shabeer THAHIR, CEng 20 July 2023 The 2023 Europe Hackathon was the largest and most successful one yet.

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ISPE

AUGUST 1, 2023

A Member’s Guide to the 2023 ISPE Annual Meeting & Expo Trudy Patterson Tue, 08/01/2023 - 13:51 iSpeak Blog iSpeak A Member’s Guide to the 2023 ISPE Annual Meeting & Expo Edyna Miguez 1 August 2023 The 2023 ISPE Annual Meeting & Expo is just around the corner, taking place at Mandalay Bay in Las Vegas, NV from the 15th to the 18th of October 2023.

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ISPE

NOVEMBER 2, 2022

iSpeak Blog. Applying what has been learned over the last three years to update pharmaceutical companies’ approaches to development and implementation is key as the industry crafts its strategies in an increasingly digital and global environment. 2022 ISPE Annual Meeting: Transform, Collaborate, & Innovate for the Path Forward.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Hospitals 98

ISPE

NOVEMBER 30, 2022

iSpeak Blog. Pharmaceutical companies are seeing the benefits of deploying PPM at multiple sites, such as monitoring and alerting on factors causing equipment degradation, optimizing equipment availability, and ensuring on-time delivery of medicines across product lines. Trudy Patterson. Wed, 11/30/2022 - 14:39. Monica Lomeli.

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Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JUNE 7, 2023

Member Spotlight: Thomas Carganico Trudy Patterson Wed, 06/07/2023 - 10:31 iSpeak Blog iSpeak Member Spotlight: Thomas Carganico Edyna Miguez 7 June 2023 Since 2013, Thomas Carganico has worked extensively within the pharmaceutical services industries across the US, UK, and Europe. How has ISPE helped advance your career?

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Communication 94

ISPE

DECEMBER 1, 2022

iSpeak Blog. For the fourth consecutive year, the annual ISPE Italy Affiliate Award for women in the pharmaceutical sector will be organized by the local group of ISPE Women in Pharma® (WIP). Trudy Patterson. Thu, 12/01/2022 - 14:46. The “Graziella Molinari Women in Pharma Award” Announced for 2022 Edition at the ISPE Italy Affiliate.

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ISPE

MARCH 28, 2023

With multiple geopolitical and pandemic related challenges in recent years, having a robust supply chain has increasingly become a strategic advantage for the pharmaceutical industry. The pharmaceutical supply chain runs through the entire process of new drugs from innovation to clinical to approval.

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Adverse Reactions Packaging Communication Labelling 52

ISPE

MARCH 28, 2023

2022 ISPE China Pharmaceutical Supply Chain Summit Trudy Patterson Tue, 03/28/2023 - 09:24 iSpeak Blog iSpeak 2022 ISPE China Pharmaceutical Supply Chain Summit 28 March 2023 On 17 December 2022, more than 100 people from all over the world gathered online for the 2022 ISPE China Pharmaceutical Supply Chain Summit.

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Adverse Reactions Packaging Communication Labelling 52

ISPE

AUGUST 30, 2023

WuXi Biologics has almost 600 global partners, including all the top 20 pharmaceutical companies. To take advantage of ABEC’s and other providers’ capabilities, WuXi Biologics engineers developed what they call the Facility Fit Tool. It provides a means of detecting potential gas leaks.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies 98

ISPE

SEPTEMBER 22, 2022

iSpeak Blog. The need for accelerated project delivery in pharmaceutical drug development and manufacturing has become a common practice. VTU Engineering. Project Manager & Pharmaceutical Consultant. ISPE BeNeLux PM CoP: Need for Speed in Pharma. Trudy Patterson. Thu, 09/22/2022 - 12:03. Natalia Nikolaevna Vtyurina, PhD.

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Vaccines 52

ISPE

FEBRUARY 21, 2023

20 Important Quotes That Can Change Your Company’s Culture Trudy Patterson Tue, 02/21/2023 - 15:43 iSpeak Blog iSpeak 20 Important Quotes That Can Change Your Company’s Culture Edyna Miguez 21 February 2023 The 2023 Facilities of the Future Conference Women in Pharma panel welcomed a full room. Women in Pharma

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Insurance 52

ISPE

DECEMBER 1, 2022

iSpeak Blog. Global Head Technology & Engineering. Concluding the track was a collaboration panel on ‘ Industry - Regulator - External CMO/CDMO ’ moderated by Vee Revithi (Senior Consultant to Pharmaceutical Regulatory Authorities on GMP, GDP; Greece) with panellists Vivian J. Trudy Patterson. Thu, 12/01/2022 - 07:06.

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Vaccines 52

ISPE

MARCH 21, 2023

™ DACH Emerging Leader Hackathon Trudy Patterson Tue, 03/21/2023 - 15:57 iSpeak Blog iSpeak 2022 ISPE Pharma 4.0™ The ISPE Hackathon program is an integral part of ISPE's success as it brings together and connects the world's young talent with each other and with the experienced leaders of the pharmaceutical industry.

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ISPE

APRIL 19, 2023

What about the engineers? directors, managers, in-house engineers, quality, consultants, etc.) iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry. The analysts? The suppliers? What profiles can be involved in providing support?

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Documentation Communication 52

ISPE

NOVEMBER 10, 2022

iSpeak Blog. Project Management (PM) - Geert-Jan Derksen (Project Manager, Yxion) and Edward Oostenbrink (Process Engineer, Yxion). Roel Nieuwenhuis (GAMP representative; Validation Engineer at Astellas Pharma). We are constantly looking for great minds and ideas that will help our pharmaceutical community to grow and develop!

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ISPE

NOVEMBER 2, 2022

iSpeak Blog. He thanked the outgoing Board members for their contributions: Heather Bennett-Kelley, Project Manager/Engineer, ACCO Systems; Chris Chen, CEO, WuXi Biologics Co. David Doleski, Head of Global Quality Audit and External Engagement, Sanofi; and Lou Kennedy, CEO and Owner, Nephron Pharmaceuticals. Trudy Patterson.

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Documentation Compounding Communication FDA 52

ISPE

OCTOBER 31, 2022

iSpeak Blog. ISPE President Tom Hartman added, “These are stories of people in the pharmaceutical industry as they endeavored to overcome seemingly impossible odds.”. Winners of these awards exemplify the ideals of FOYA and demonstrate ISPE’s dedication to enhancing patient health thru advancements in pharmaceutical manufacturing.

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Vaccines Packaging 52

ISPE

NOVEMBER 23, 2022

iSpeak Blog. Djamila Harouaka, an advisor in the Office of Pharmaceutical Quality, USFDA/CDER, presented FDA’s Quality Management Maturity Program. The speakers, Dennis Powers, Vice President of Business Development & Design Consulting, Gcon; Rick Panton, Principal Engineer, Roche; and Thomas F. Trudy Patterson.

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FDA Documentation 52

ISPE

OCTOBER 28, 2022

Pharmaceutical Engineering® recently spoke with Neadle about the Communities of Practice and issues related to the importance of combination products in the industry. We have industry representatives spanning international pharmaceutical, biotech, and device companies, as well as consultants.

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FDA 52

ISPE

OCTOBER 31, 2022

iSpeak Blog. ISPE President Tom Hartman added, “These are stories of people in the pharmaceutical industry as they endeavored to overcome seemingly impossible odds.”. Winners of these awards exemplify the ideals of FOYA and demonstrate ISPE’s dedication to enhancing patient health thru advancements in pharmaceutical manufacturing.

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Vaccines Packaging 52