ISPE

JULY 19, 2023

™ conference was held December 2022 in Vienna, Austria, in combination with the Aseptic Processing conference. ™ Is Gaining Momentum and Driving Innovation Trudy Patterson Wed, 07/19/2023 - 08:17 Online Exclusives July / August 2023 Pharma 4.0™ ™ Is Gaining Momentum and Driving Innovation Thomas ZIMMER, PhD 19 July 2023 The fifth Pharma 4.0™

Documentation 98

Documentation FDA Labelling Communication 98

European Pharmaceutical Review

OCTOBER 9, 2022

This process influences protein activity in cancerous cells, causing tumours to become inflamed and the blood vessels to haemorrhage and die. EBC-46 contains the protein kinase C (PKC) which regulates gene expression and cell proliferation. The team at Stanford University applied this knowledge and synthesised it for real-world use.

Compounding 137

Compounding FDA 137

pharmaphorum

MARCH 15, 2022

Life science companies invest a significant number of resources to engage physicians and patient advocates. However, companies often fall short when it comes to engaging patients in a meaningful way during the product development process. Choosing the right questions to prompt robust discussion. How to maintain confidentiality.

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ISPE

NOVEMBER 10, 2022

As cell manufacturing is a live continuous process, it requires a different approach from conventional chemical compounds and small molecules manufacturing. I focus my work to improve the required methods, equipment, and systems for our emerging industry to scale to meet our vision.

Documentation 98

Documentation Compounding Hospitals Immunization 98

Hospital Pharmacy Europe

OCTOBER 26, 2023

By developing a rigorous credentialing process and a clearly defined post-registration career pathway for pharmacists specialising in critical areas of patient care , the initiative aims to offer professional growth for pharmacists and a robust assurance mechanism for employers and patients.

Patient Care 52

Patient Care Hospitals Specialty Pharmacies 52

pharmaphorum

NOVEMBER 29, 2021

The Congress gathers pharmaceutical companies, CMOs and CDMOs, governmental bodies together with pharmaceutical equipment providers and service companies. One of the major challenges for pharmaceutical executives is to manage the leveraging manufacturing and packaging processes.

Packaging 71

Packaging Pharmaceutical Companies Pharmaceutical Companies 71

ISPE

OCTOBER 27, 2022

These considerations include processing safety (e.g., levels of biological, chemical, and solvent handling safety), multiple scaled-out batches, and the requirement for end-to-end aseptic processing. In many C> processes, success is dependent on the ability to efficiently deliver new genetic material to the target cells.

Packaging 52

Packaging Communication Immunization Vaccines 52

European Pharmaceutical Review

APRIL 4, 2024

Barry noted that to help to overcome the current workforce skill shortage, CGT Catapult is leveraging insights from its in-depth training needs analysis “to develop national training programmes which aim to equip healthcare professionals with essential skills for navigating the complexities of ATMP trials.”

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European Pharmaceutical Review

JULY 24, 2023

PACMI has several advantages, including: Making it possible to expand the samples and destructive tests and dedicate more resources, facilities, and equipment Allows for more in-depth knowledge of the product and the processes used Allows for proposed improvements that increase the overall quality for improved patient health.

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Compounding Documentation 73

ISPE

JANUARY 11, 2023

Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation. Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation. 1 US Food and Drug Administration.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

ISPE

APRIL 12, 2023

Paperless validation is applicable to every type of validation in biotech: cleaning, process, equipment, facilities, utilities, and many others. Longer timelines, more human errors, and burdensome compliance efforts are all consequences of this outdated process. The continued use of paper validation in a Pharma 4.0

Documentation 98

Documentation FDA 98

ISPE

JULY 10, 2023

It offers potential safety benefits and requires a smaller facility footprint,” said Guide Co-lead Dave DiProspero, Director of Pharmaceutical Process Technology, CRB. Meet Heather Patterson, Human Resources Manager. Facilities & Equipment Product Development Adv Manuf Manufacturing Operations OSD

Dosage 52

Dosage Pharmaceutical Companies Pharmaceutical Companies Communication 52

ISPE

MARCH 15, 2023

In facility design, solutions are derived through science-based analyses of environmental impacts from the materials, processes, services, and architecture. 1 This view prioritizes steps that reduce the use of natural resources and the release of undesirable products such as carbon to the atmosphere or plastics to landfills.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

ISPE

JULY 7, 2023

1 Some advantages are apparent based on the nature of a continuous processing, including higher efficiency at lower cost. 1 Some advantages are apparent based on the nature of a continuous processing, including higher efficiency at lower cost. 1 , 2 , 3 There are also barriers to the adoption of BCM. 1 a b c Gerstweiler, L.,

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JANUARY 9, 2023

Using Technology for Continuous Process Verification 4.0 Trudy Patterson Mon, 01/09/2023 - 12:20 Features January / February 2023 Using Technology for Continuous Process Verification 4.0 ™ technological solutions that can enhance continuous process verification (CPV) 4.0 Marc Olivé Torralba Bryon D. are discussed. 1 Tebar, A.,

Documentation 52

Documentation Communication 52

pharmaphorum

OCTOBER 20, 2022

Especially given different stakeholders within companies continue to work in silos, a centralised database of actionable information simplifies the essential elements of brand strategy to better equip pharmaceutical organisations for success. Biopharma companies need not waste resources when allocating their brand resources.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Data Entry Documentation 98

Omnicell

JANUARY 10, 2023

When we digitize processes , we not only connect different methods , but end up connecting people as well. The benefits are many, including faster and more efficient business processes. The daily job of a pharmacist can be full of time-consuming manual processes. Digital transformation is the digital way of life.

Compounding Pharmacies 52

Compounding Pharmacies Omnicell Compounding Communication 52

European Pharmaceutical Review

APRIL 18, 2024

Choosing the sample location, sample type/sampling equipment, number of samples and sample dates will depend on several factors, including: API of interest, sampling objectives, analytical target and data quality objectives, site production schedule and wastewater discharge temporal variations, and residence times in collection/treatment systems.

Pharmaceutical Companies 83

Pharmaceutical Companies Pharmaceutical Companies 83

European Pharmaceutical Review

JULY 8, 2022

While some risks related to the processes and facilities becoming obsolete or incremental modifications over time making production less efficient, he also included microbial contamination concerns, which will be the focus of this summary.

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pharmaphorum

DECEMBER 21, 2021

In early 2020, health officials were cautious about forecasting a COVID-19 vaccine timeline to the public, as vaccine discovery was a historically laborious process that took years (if not decades). Yet a successful COVID-19 vaccine gained emergency approval in just 11 months, a blistering pace that likely saved millions of lives.

Pharmaceutical Companies 115

Pharmaceutical Companies Pharmaceutical Companies Vaccines Communication 115

pharmaphorum

NOVEMBER 23, 2021

The funding & resource benefits of WGS. The financial argument for WGS lies in the potential savings that it could bring to diagnostic processes overall. This is also reflected in the resourcing required to treat an undiagnosed condition.

Hospitals 115

Hospitals Clinic Management 115

ISPE

NOVEMBER 22, 2022

I presented on planning and executing and designing fill lines, RABS, Isolators, and transfers – along with the differences between processing potent compounds versus non- potent compounds. Director Aseptic Processing SME. When I started attending and speaking at the ISPE Aseptic Conference in the 2000s, I came to grow and learn.

Compounding 98

Compounding Packaging Dosage Vaccines 98

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.

Documentation 98

Documentation FDA 98

ISPE

OCTOBER 28, 2022

However, equally important from both a business and regulatory perspective, the guide established good engineering practice (GEP) as a key enabler for the integrated C&Q process. Just as QRM drives effectiveness of the integrated C&Q process, GEP drives the efficiency of that process. System Life-Cycle Processes.

Documentation 98

Documentation 98

PharmaShots

JUNE 14, 2023

These courses are taught at dedicated training sites with fully equipped classrooms and laboratories in more than 50 locations around the world. About Agilent University Agilent University provides training courses and resources for laboratory professionals.

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ISPE

SEPTEMBER 29, 2023

While it is very energy-consuming to produce these therapies, Takeda paid special attention to the facility’s design to optimize the processes and to make them, and the site, as energy efficient as possible in keeping with their commitment to minimize environmental impact and progress towards future sustainability goals.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Labelling Patient Care 52

ISPE

JUNE 15, 2023

™” applies to all life sciences products including pharmaceuticals, medical devices, and hybrid products, as well as equipment and systems facilitating development and production of activities. It is also important to note that “Pharma 4.0™”

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ISPE

MARCH 6, 2023

The pharmaceutical industry commits substantial resources in new medicines and treatment options to combat a variety of illnesses and diseases affecting communities globally. while meeting patient needs as a primary goal. Sustainability Definitions The term sustainability has several distinct meanings in various contexts.

Communication 52

Communication Patient Care 52

ISPE

MAY 9, 2023

It is one of many companies building out existing facilities—such as an expansion of its BioProcess Innovation Center in Morrisville that will double the company’s process characterization and clinical process development capacity—as well as opening new facilities outside the Triangle.

Vaccines 94

Vaccines Pharmaceutical Companies Pharmaceutical Companies Medical Schools 94

ISPE

SEPTEMBER 8, 2023

The bottom line is that aseptic production equipment should be designed well, and other than machine components that are absolutely necessary, such as filling nozzles and stopper placement equipment, there shouldn’t be any things that are directly above the product. This needs to be demonstrated in the smoke study qualifications.

FDA 52

FDA Vaccines Documentation 52

ISPE

SEPTEMBER 11, 2023

In comparison to traditional large-scale manufacturing operations, decentralized modes of manufacturing can be more agile, more transportable, and tailored for specific modalities or production processes. ™ technologies.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. USP has also launched the Nitrosamines Exchange – a community hub and virtual platform.

FDA 92

FDA Compounding 92

DiversifyRx

FEBRUARY 7, 2024

There’s no need to reinvent the wheel; leveraging existing resources is key. The Importance of Financial Forecasting for Pharmacies – Strategic process of predicting future financial outcomes and trends. At DiversifyRx, our team is equipped to support you across all facets of your pharmacy. This blog is for you!

Independent Pharmacies 52

Independent Pharmacies 52

pharmaphorum

MARCH 10, 2022

However, biologics are complex by nature and do not fit the traditional production processes of synthesised small molecule medicines. Reducing reliance on external resources gives drugmakers greater control over production processes, from cells to a final product. About the interviewee.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Packaging Immunization 98

PQA

MARCH 28, 2024

This is challenging, time-intensive and resource-heavy work – and PQA is the leading organization doing this in medication use quality. The sale of PQS will enable PQA to invest resources in our mission and address our members’ top priorities with confidence in a challenging and uncertain environment.

Immunization 40

Immunization 40

The FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). By Véronique Li, Senior Medical Device Regulation Expert & Anne K. This statistic is quite disheartening.

FDA 59

FDA Documentation Labelling Communication 59

The Checkup by Singlecare

FEBRUARY 7, 2023

Medical supplies/equipment: Medical supplies related to the patient’s condition may be provided at little to no cost (e.g., Educational resources: Most PAPs provide educational resources such as brochures, videos, and online materials to help patients better understand their condition and treatment options.

Insurance 98

Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 98