ISPE

NOVEMBER 22, 2022

Top 5 Reasons to Attend the 2023 ISPE Aseptic Conference. Top 5 Reasons to Attend the 2023 ISPE Aseptic Conference. 1) Committed People Move the Industry. ISPE Aseptic is one of those conferences where the depth of knowledge astounds me. ISPE Aseptic is one of those conferences where the depth of knowledge astounds me.

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ISPE

MAY 10, 2023

The ISPE Good Practice Guide: Containment for Potent Compounds covers all aspects of pharmaceutical containment, including background to safe working levels, mechanisms of exposure, and how exposure can be controlled. Tell us about your role at ISPE: What do you do each day? ISPE is always looking for new talent.

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ISPE

MAY 10, 2023

An ISPE member since 1982, Terry has also served on the ISPE International Board of Directors and helped plan ISPE annual meetings. We have people from different aspects of the industry—owners, manufacturers: all the people involved have different outlooks on what is going on and the resources you need.

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ISPE

SEPTEMBER 8, 2023

2023 ISPE Annual Meeting & Expo Q&A Logan Thomas Fri, 09/08/2023 - 13:50 InTouch September / October 2023 2023 ISPE Annual Meeting & Expo Q&A Joydeep Ganguly 1 September 2023 The Executive Chair for this year’s Annual Meeting offers advice and shares what attendees can expect at the upcoming conference in Las Vegas, Nevada.

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ISPE

JULY 7, 2023

CoP Leader Profiles: Christian Wölbeling Trudy Patterson Fri, 07/07/2023 - 12:16 InTouch July / August 2023 CoP Leader Profiles: Christian Wölbeling Marcy Sanford 1 July 2023 Christian Wölbeling has been a member of ISPE for 25 years. A founding member and current Chair of ISPE’s Pharma 4.0™ Open to all ISPE members, the Pharma 4.0™

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ISPE

NOVEMBER 30, 2022

ISPE Communities of Practice Leaders – Nik Krpan. ISPE Communities of Practice Leaders – Nik Krpan. We started with five people and now we have more than sixty. Within pharma, I think water is a great place for people to start a career in process engineering. Nik has been a member of ISPE since 2004. iSpeak Blog.

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ISPE

NOVEMBER 10, 2022

ISPE NL Emerging Leaders (EL) Career Workshop. ISPE NL Emerging Leaders (EL) Career Workshop. At 20:00 a one-hour workshop was kicked off by a Vice-Chair of ISPE the Netherlands Emerging Leaders Natalia Vtyurina (Sr QA Officer at Halix) highlighting opportunities that ISPE offering to their members locally and globally.

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ISPE

MARCH 21, 2023

2022 ISPE Pharma 4.0™ ™ DACH Emerging Leader Hackathon Trudy Patterson Tue, 03/21/2023 - 15:57 iSpeak Blog iSpeak 2022 ISPE Pharma 4.0™ ™ DACH Emerging Leader Hackathon Miriam Kremer-van Der Kamp Vinzenz Abt Josef Trapl 21 March 2023 The 2022 ISPE Pharma 4.0™ 2022 ISPE Pharma 4.0™

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ISPE

MARCH 8, 2023

ISPE Briefs: New Guide Promotes Cultural Excellence Trudy Patterson Wed, 03/08/2023 - 10:07 InTouch March / April 2023 ISPE Briefs: New Guide Promotes Cultural Excellence Marcy Sanford 1 March 2023 Cultural excellence is the expressed and implied ways in which an organization operates. What do you love about your job?

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ISPE

MAY 10, 2023

What is ISPE?” “Why We’ve been asked these and many more questions multiple times since joining ISPE. After the ISPE Emerging Leaders Future Leaders’ Days 2022, we wish we had taken everyone who had ever asked us a question about ISPE with us. The ISPE Emerging Leaders CoP has regional subgroups spread across the globe.

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ISPE

SEPTEMBER 8, 2023

Member Spotlight: Danielle Gabrish Trudy Patterson Fri, 09/08/2023 - 11:43 iSpeak Blog iSpeak Member Spotlight: Danielle Gabrish Edyna Miguez 8 September 2023 Danielle Gabrish is the Director of Clinical Biologics at AstraZeneca and the Chair of the ISPE Women in Pharma ® group for ISPE’s Chesapeake Bay Chapter.

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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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ISPE

JULY 7, 2023

CoP Leader Profiles: Heather Watson Trudy Patterson Fri, 07/07/2023 - 12:01 InTouch July / August 2023 CoP Leader Profiles: Heather Watson Marcy Sanford 1 July 2023 Heather Watson has been a member of ISPE for 22 years. She has been the Co-Chair of tracks at several ISPE Europe Annual Conferences and has presented at ISPE annual meetings.

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Communication 52

ISPE

NOVEMBER 9, 2022

2022 ISPE International Emerging Leader Hackathon. 2022 ISPE International Emerging Leader Hackathon. Over 30 ISPE Emerging Leaders, Coaches, and Supporters converged during the Hackathon Reception on Friday 28 October 2022 at 1900 hrs. The hacker, Yanet Flor, won the game and was awarded a one-year ISPE Membership.

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ISPE

JANUARY 10, 2023

The risk of contamination of a sterile product from the environment (room) and the people who do work in it was recognized early on, and this work should be done in a better protective measure. The first ISPE Barrier Conference to address all the risks of the sterile pharmaceutical product took place 32 years ago.

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ISPE

SEPTEMBER 22, 2022

ISPE BeNeLux PM CoP: Need for Speed in Pharma. ISPE BeNeLux PM CoP: Need for Speed in Pharma. Contact us via info@ispe-events.eu Thanks to the organizers of the event from ISPE BeNeLux PM CoP: . The ISPE Project Management CoP Benelux was founded in 2012. Trudy Patterson. Thu, 09/22/2022 - 12:03. iSpeak Blog.

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ISPE

MARCH 3, 2023

ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track! Trudy Patterson Fri, 03/03/2023 - 13:15 iSpeak Blog iSpeak ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track! 2023 ISPE Biotechnology Conference Frank Henrichmann Heather D.

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ISPE

OCTOBER 28, 2022

Combination Products is one of ISPE’s newest Communities of Practice (CoPs). It started as a Special Interest Group to help people in the industry collaborate and learn from each other. Why Is Your Communities of Practice’s Work Critical to ISPE and the Industry? Marcy Sanford. 1 November 2022.

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ISPE

MAY 2, 2023

It is a great honor and pleasure for me as Chair of the 2023 ISPE Annual Meeting Planning Committee to give you an overview of the upcoming conference including information about the knowledge that will be shared, a look at keynote speakers, and details about a few of the networking opportunities.

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ISPE

MARCH 8, 2023

These leaders are central to the success of ISPE’s CoPs, which spearhead the generation of ISPE’s gold standard content, including Good Practice Guides, Pharmaceutical Engineering articles, conference presentations, and training programs. The new series follows the CoP profiles series published in the magazine during 2022.

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Controlled Substances 52

ISPE

MARCH 28, 2023

With the help of ISPE, this summit brings together experts in the field of biopharmaceutical supply chain to jointly solve industry problems and improve the industry's capabilities. The pharmaceutical supply chain runs through the entire process of new drugs from innovation to clinical to approval.

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ISPE

NOVEMBER 1, 2022

2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. 2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. Trudy Patterson. Tue, 11/01/2022 - 06:49. iSpeak Blog. Susan Sandler. 1 November 2022. President and CEO. Jörg Zimmermann. President & CEO.

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ISPE

FEBRUARY 17, 2023

Streamlining and having a series of linked products could help in coming up with therapies for small numbers of people; this could also help with product manufacturing updates since with 20 linked products, updating manufacturing of the originator product could “waterfall” to the rest. The primary obstacle to successful scaling of industry 4.0

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ISPE

APRIL 17, 2023

The union of these technologies meets the regulatory goals of eliminating the most abundant source of error and contamination, the people involved within the aseptic manufacturing processes. Ideas and opinions expressed in iSpeak Blog posts are those of the author(s) and publication thereof does not imply endorsement by ISPE.

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ISPE

JUNE 26, 2023

™ Thomas ZIMMER, PhD 26 June 2023 The upcoming challenges and opportunities of digital transformation were the topic of a panel discussion held on 9 May 2023 at the 2023 ISPE Europe Annual Conference in Amsterdam, The Netherlands. It must be people who make decisions about batch release.

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ISPE

FEBRUARY 7, 2023

The conference opened on 31 January with a welcome message from Thomas Hartman, ISPE President and CEO, who said that there were more than 400 attendees in the North Bethesda, Maryland, conference site and in virtual attendance. She said that 10 people have been dosed and they do have 14-day resonance. Prefabrication can also help.

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ISPE

FEBRUARY 28, 2023

International Women’s Day has taken place for over a century, with the first taking place in 1911 and having the support of over a million people. This International Women’s Day, we decided to ask our ISPE Women in Pharma leaders how they felt about the 2023 theme, #EmbracingEquity. We should not think we can achieve equity easily.

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ISPE

FEBRUARY 21, 2023

Here’s a list of the 20 most powerful key takeaways: Diversity of Thought “Encourage people to speak up. There are some cultures in which it’s respectful to not speak over people. Whether you’re talking about gender or age.” - Vivianne Arencibia “There’s an opportunity to really have people shine. Prompt them to speak.

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ISPE

FEBRUARY 16, 2023

Regulators discussed those changes and how they impact manufacturing practices during panel discussions held 7 - 8 December 2022 at the ISPE Pharma 4.0™ Hiring people with the right skillset and knowledge with the appropriate training is key for assessing aseptic processing. ™ and Annex 1 Conference. This is a key concern for the FDA.

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ISPE

SEPTEMBER 13, 2023

This is why they are also being recognized in the category of Social Impact, as it exemplifies how agility in delivery in such an accelerated timeframe can have a positive impact on the well-being of millions of people. Register Now! NOMINATE YOUR FACILITY FOR THE 2024 FOYA PROGRAM! Applications must be submitted by 4 December 2023.

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ISPE

SEPTEMBER 29, 2023

About the Company: Takeda is a global values-based, R&D-driven biopharmaceutical leader committed to creating better health for people and a brighter future for the world. Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2024 FOYA program winner. Register Now!

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ISPE

MAY 10, 2023

What role does ISPE play in all of this? I think trade associations like ISPE play a very important role in promoting best practices: they inform public policies and regulations and develop industry standards. ISPE is a great example of how companies can come together, not as competitors, but as collaborators to help patients.

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ISPE

FEBRUARY 8, 2023

In Europe, it felt like every day brought a new rule to set you back to the drawing board, when an approval of a mere clinical trial application was a never-ending process, with people sometimes looking at you and secretly thinking, “Why bother? Learn More & Register 2023 ISPE Aseptic Conference It will never happen.”

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ISPE

SEPTEMBER 8, 2023

2023 ISPE Aseptic Conference Regulatory Panel Logan Thomas Fri, 09/08/2023 - 11:35 InTouch September / October 2023 2023 ISPE Aseptic Conference Regulatory Panel Jörg Zimmermann 1 September 2023 On 7 March 2023, ISPE concluded the 2023 ISPE Aseptic Conference with a regulatory panel question and answer session.

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ISPE

MAY 10, 2023

The ISPE QC/Analytical CoP was established in 2022 to provide a forum for knowledge sharing on a range of topics including out of specification (OOS) investigations, method validation, compendial harmonization, analytical methods lifecycle management, and implementing innovations, such as real-time release. “One

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ISPE

MARCH 29, 2023

As we are not all from the same CoP, we first needed to establish a way to connect and collaborate with all members of ISPE. an industry working group within ISPE with the main objective of defining tangible ways we can move this needle from the validation perspective. What are you working on now to drive digital adoption?

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ISPE

DECEMBER 6, 2022

As we are not all from the same COP, we first need to establish a way to connect and collaborate with all members of ISPE. A subset of people may have access to information and spend time digging into data not relevant to their job function. Access controls can ensure access is granted to the right people. Perceived Risks.

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