pharmaphorum

NOVEMBER 17, 2021

Topics of discussion will include the latest updates on the EU MDR, Article 117 and UK regulatory guidance from the MHRA, insights into the evolving digital health landscape for connected delivery devices, containment considerations for novel delivery, patient centric approaches to device design and much more….

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ISPE

SEPTEMBER 11, 2023

There are regulatory strategies and technologies emerging to address these challenges, but further progress must be made to fully harness the advantages of advanced and decentralized manufacturing techniques. ™ technologies.

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ISPE

SEPTEMBER 28, 2023

It's no wonder that global pharmaceutical companies are increasingly sourcing innovation through alliances and partnerships with their peers in California. The stringent regulatory framework, encompassing sustainability demands, code requirements like Title 24, and meticulous regulatory reviews, might initially appear daunting.

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ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Regulatory submission and evaluation of chemistry, manufacturing, and controls (CMC) data may be required for changes that have a higher risk to impact product quality. Michael Abernathy.

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ISPE

NOVEMBER 2, 2022

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. Project Manager/ Engineer.

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ISPE

NOVEMBER 1, 2022

Zipp spoke next to welcome attendees, who she encouraged to make the most of the meeting through sessions and meeting with colleagues, noting that many key topics are being covered. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Director, Office of Pharmaceutical Quality. Quality, Defined.

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ISPE

MARCH 23, 2023

As the momentum grows in the rollout of various digital tools to aid verification and validation in the pharmaceutical space there are many questions in relation to the correct application of the True Copy process to digital evidence within protocols in a paperless validation system. However, for higher risk data (i.e.,

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Documentation FDA 98

Viseven

OCTOBER 26, 2022

The pharmaceutical industry still faces significant challenges and is looking for innovative solutions. Below are five of the most significant pharmaceutical industry problems. . Therefore, to reduce the challenges of their pharmaceutical supply chain, they changed their strategy and made the most use of the resources available.

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ISPE

APRIL 19, 2023

What about the engineers? Ensure compliance with the requirements, checking that everything is complete and accurate before delivery. directors, managers, in-house engineers, quality, consultants, etc.) directors, managers, in-house engineers, quality, consultants, etc.) The analysts? The suppliers?

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ISPE

SEPTEMBER 12, 2022

2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More. 2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More. Director, Office of Pharmaceutical Quality Operations. Corporate Regulatory Compliance & Enforcement Advisor.

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ISPE

MARCH 7, 2023

Melton, PhD 1 March 2023 The imperative for global action to tackle climate change is clear and the pharmaceutical industry has a key role to play. 1 , 2 The effect to the pharmaceutical industry spans its end-to-end activities, including the residual impact of used and unused medicines on the environment.

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Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. However, some of the products manufactured in a topical drug facility can be difficult to clean. Lopolito Steven M.

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ISPE

OCTOBER 27, 2022

As digital health sits at the intersection of technical, scientific, and regulatory disciplines involving medical devices, drugs, and biologics, the successful development of novel DHTs will require significant collaboration with health care stakeholders to overcome regulatory, technical, and life-cycle management challenges.

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Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

MARCH 15, 2023

Whitford Emily Heffernan, PE Aoife Kelly 1 March 2023 Many emerging tools and technologies support the environmental sustainability of the pharmaceutical industry. Green Manufacturing for the Pharmaceutical Industry.” 7 An integrative (vs. 7 An integrative (vs. 7 An integrative (vs. 1 Circular Economy Practitioner Guide.

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ISPE

OCTOBER 27, 2022

As digital health sits at the intersection of technical, scientific, and regulatory disciplines involving medical devices, drugs, and biologics, the successful development of novel DHTs will require significant collaboration with health care stakeholders to overcome regulatory, technical, and life-cycle management challenges.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Pharmaceutical Engineering (May/June 2019).

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ISPE

NOVEMBER 10, 2022

His facility gained regulatory approval and supplied the first chimeric antigen receptor T cells (CAR-T) product to young patients with leukemia. Pharmaceutical Engineering® recently spoke with Kawamata about his work. Why do you see digitalization is such an important topics for cell therapy? FBRI at Kobe.He

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European Pharmaceutical Review

OCTOBER 2, 2023

Regulatory and Compliance 10. At the Heart of Pharma Conference agenda highlights CPHI Barcelona 2023 will feature an extensive conference agenda covering a wide range of topics, including next-gen biomanufacturing, partnering for success, formulating the future, future therapies, manufacturing 4.0, Packaging & Machinery 7.

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Packaging 102

PharmaShots

FEBRUARY 27, 2023

The theme of the event was Innovation, Advanced Technology, Current Challenges & Opportunities in Pharma & Healthcare Industry under which a series of presentation sessions and panel discussions were held related to pharma trends, APIs, policy reforms, AI, metaverse, current regulatory trends and the direction of pharma and drug discovery.

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Roots Analysis

SEPTEMBER 22, 2023

These significant benefits offered by wearable injectors, coupled with their rising demand in the pharmaceutical industry and healthcare sector, worldwide is likely to drive market growth during in the coming years. Their approval requires relatively less regulatory proceedings and controls.

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Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The document contains detailed information on the providers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

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