XTalks

NOVEMBER 6, 2024

XTALKS WEBINAR: Unlock Growth in Medical Device Manufacturing with an AI-Powered eQMS Live and On-Demand: Monday, December 9, 2024 , at 11am EST ( 4pm GMT / UK) Register for this free webinar to discover how AI integration can transform compliance, streamline operations and position medical device manufacturers for unprecedented growth.

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XTalks

JANUARY 29, 2025

Philadelphia, PA PCI Pharma Services (“PCI”), a leading global contract development and manufacturing organization (CDMO) specializing in complex biopharma therapies, has announced a monumental investment exceeding $365 million.

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Pharma Packaging Solutions

JUNE 9, 2023

Quality medical device packaging is crucial for the health and well-being of countless people all around the world. With such an important job to do, it’s essential that the medical device packaging you choose for your product is up to the task. Here are a few factors to take into consideration when selecting medical device packaging.

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Packaging Packaging Pharma Packaging Compliance 52

Pharmaceutical Technology

SEPTEMBER 5, 2022

Quality in terms of number of defective items, packaging and labelling, quality management system certification, research, development, and innovation. The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

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Packaging Packaging Compliance Manufacturing 130

Roots Analysis

APRIL 20, 2022

This continuously growing pipeline of pharmaceutical drug products has inadvertently led to an increase in the demand for their associated primary packaging and Secondary Packaging solutions. . 3] Some of the advantages offered by pharmaceutical secondary packaging have been depicted below. Company Competitiveness Analysis.

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FDA Law Blog

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M.

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Cosmetics Compliance Production Regulation 59

Advarra

SEPTEMBER 8, 2022

After platform review, if a decision is made to validate, staff should generate documentation to ensure Part 11 compliance. As the first requirement in Part 11 compliance, validation is systematic documentation for a system’s requirements. This review can be documented in a vendor’s audit or within your own validation package.

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Pharmaceutical Technology

JUNE 19, 2023

Staying informed of regulatory changes is crucial for businesses to ensure continued compliance and avoid disruptions in their operations. Luigi Galuffo is business development director and based in Germany, where the company houses its site, capable of providing storage for temperatures as low as -80°C.

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Cloudbyz

MARCH 3, 2023

Regulatory Compliance Compliance with regulatory requirements is critical for CROs. This can make it challenging to ensure compliance with the latest regulations and guidelines. Larger CROs may offer more attractive compensation packages and career advancement opportunities.

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Pharma Packaging Solutions

NOVEMBER 11, 2024

By providing all required components in one package, medical device kitting reduces the duration of procedures and improves overall productivity. Medical device kitting promotes standardization by packaging specific components together, ensuring the same tools and supplies are used across different procedures or facilities.

Packaging 52

Packaging Packaging Compliance Pharma Packaging 52

XTalks

JULY 19, 2024

The term “daily value” is central to understanding the Nutrition Facts label, a staple on nearly every packaged food product in the US since 1994. Packaging also plays a role. The Association of Official Analytical Chemists (AOAC) played a significant role in this development.

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Packaging Packaging Compliance Production 91

Cloudbyz

JUNE 21, 2023

Understand SDTM: The SDTM is a data standard developed by the Clinical Data Interchange Standards Consortium (CDISC) that provides a structured format for organizing and submitting clinical trial data. Ensure compliance with regulatory requirements, such as those specified by the U.S. Exported data may be in a raw format (e.g.,

Clinical Trials 93

Clinical Trials Clinical Trials Compliance Trials 93

pharmaphorum

AUGUST 5, 2020

Workshop will be on ‘Ophthalmic Drug Delivery Development – Trials and Tribulations’. Ophthalmic Drug Delivery is compelling for many reasons, including the major issue of patient compliance and tolerability of therapies. Understanding the pharmacological challenges for DD and development pathway including cost and timelines.

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Drug Delivery Development Trials Drugs 52

pharmaphorum

NOVEMBER 24, 2022

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. million to deliver – as well as demanding specialist skills to maintain to industry standards – their widespread development has been slow. Enter cleanrooms-on-demand….

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Manufacturing Pharma Packaging Production Packaging 98

Pharmaceutical Technology

NOVEMBER 25, 2022

But the challenges for drug producers developing PDFs are numerous and varied. Formulation decisions made in the development of PDFs can have important implications for drug stability, patient compliance, and accurate dosing. In nearly all cases, developing a PDF from an ADF requires additional product development work.

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Manufacturing Production Pharma Companies Development 130

Cloudbyz

MAY 11, 2023

Understanding the factors driving clinical trial costs is essential for researchers, sponsors, and other stakeholders involved in the drug development process. These costs may also involve audits, inspections, and any corrective actions required to address compliance issues. The post What Drives Clinical Trial Costs?

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XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. Some specific tasks that a clinical trial manager may be responsible for include: Developing and managing trial timelines, budgets and resources.

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Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Develop Clear and Balanced Messaging Effective communication is at the heart of pharmaceutical marketing. Keep thorough records of approvals for future reference.

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pharmaphorum

OCTOBER 12, 2022

Primary Packaging Development. Delve into the considerations for material components for the development of primary packaging. Kevin Kusmierek, Scientist, Primary Packaging and Medical Devices, CSL Behring. Mitali Aon, VP and Global Head of Device Development, Sanofi. Connected Drug Delivery Devices.

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Drugs Packaging Packaging Drug Delivery 52

The Pharma Data

MAY 26, 2023

The 6,000-square-meter Shiga site opened in October 2021 to support customers both locally and globally, providing flexible clinical supply solutions, including primary packaging, Catalent’s FastChain ® demand-led supply, white glove handling and logistics. With sites in the U.S.,

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FDA Law Blog

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

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Packaging Packaging Compliance Manufacturing 45

Cloudbyz

OCTOBER 19, 2023

The pharmaceutical industry plays a critical role in improving healthcare by developing and bringing new medicines to market. Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount.

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Clinical Trials Clinical Trials Trials Compliance 104

ACRP blog

JANUARY 11, 2024

As the saying goes, “With great power comes great responsibility,” and with so many clinical study site leaders now taking technological powers into their hands that were traditionally held by sponsors, some of them and their staff may be surprised to find the awesome responsibilities that come packaged with the deal.

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Compliance Regulation Packaging Packaging 59

FDA Law Blog

OCTOBER 31, 2021

Under SB 343, a product or packaging is not recyclable in California if: It includes components, inks, dyes, adhesives, or labels that prevent its recyclability; It contains intentionally added chemicals identified pursuant to regulations implementing section 42370.2(g)(4) g)(4) of the California Public Resources Code; or.

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FDA Law Blog

MARCH 21, 2024

Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. By John W.M. The MoCRA rollout, though, does not preclude that FDA may practice some regulation by enforcement if it deems such action necessary.

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Cosmetics Production Compliance Regulation 64

Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Develop Clear and Balanced Messaging Effective communication is at the heart of pharmaceutical marketing. Keep thorough records of approvals for future reference.

Marketing 40

Marketing Compliance Packaging Packaging 40

Clinical Trial Podcast

FEBRUARY 23, 2021

Developing and actively managing clinical trial finances, timelines, and resource allocation is necessary for a smooth trial execution. After mapping out trial assumptions such as number of sites, patients, enrollment period, monitoring, a project manager will develop the study budget and timeline with key milestones.

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Clinical Research Research Clinical Trials Clinical Trials 105

Cloudbyz

FEBRUARY 3, 2021

When adopted in clinical trials, NLP can be used to develop algorithms that can interpret notes of doctors and pathology reports of patients, thus helping to identify the right candidates for the trial. Package Installation. Package Installation - Sandbox. Package Installation. Package Installation - Sandbox.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Packaging 98

FDA Law Blog

SEPTEMBER 26, 2022

Part 820, the list provides information on integration of the design control requirements within a pharmaceutical development program and discussion of exemption from cGMP requirements for applicable device constituents. For manufacturers of CPs that have established a quality system that complies with the full requirements of 21 C.F.R.

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Production Compliance Manufacturing Regulation 40

FDA Law Blog

MARCH 3, 2024

Biotechnology equipment includes genetic sequencers, mass spectrometers, polymerase chain reaction machines or any other equipment, components or accessories designed for the research, development, product, or analysis of biological materials as well as any software, firmware, or other digital components.

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Pharma Marketing Network

DECEMBER 4, 2024

From strict regulatory environments to growing patient expectations, the industry requires a delicate balance of innovation and compliance. Always ensure your content adheres to regulatory guidelines to avoid compliance pitfalls. Automation streamlines processes like email marketing, freeing up resources for strategy development.

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The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. CluePoints provides clinical studies with risk management support package during Covid-19.

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Clinical Trials Clinical Trials Gene Trials 52

Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. Many test methods have thus been developed.

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pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. About the authors.

Life Science 98

Life Science Medicine Regulation Compliance 98

pharmaphorum

NOVEMBER 17, 2021

The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products. Daniel Latham, Head Connected Health Product Development, Novartis. BOOK BY 29 TH OCTOBER AND SAVE £200.

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Drugs Drug Delivery Engineer Production 52

XTalks

JULY 5, 2022

A corporate compliance training program is a part of many onboarding programs to ensure employees are up to date with the latest rules and regulations they must adhere to while working for the company. Novartis trains and guides associates with a structured program consisting of ethics, risk and compliance.

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Life Science Compliance Packaging Packaging 52

Pharma in Brief

DECEMBER 3, 2020

The proposed amendments to the FDR will allow COVID-19 products that were previously approved under the Interim Order for Drugs and Vaccines to apply for a notice of compliance ( NOC ) using a similar streamlined regulatory process. require market authorization holders to meet post-marketing regulatory requirements; and.

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