XTalks

AUGUST 11, 2023

Healthcare facilities management is a comprehensive approach to overseeing the various facets of healthcare facilities, spanning their development, maintenance, security and operations. Healthcare facilities management roles can be categorized into distinct areas: Operations, Maintenance, Security, Compliance and Facility Development.

Compliance 96

Compliance Contamination Production Marketing 96

FDA Law Blog

NOVEMBER 30, 2022

The purpose of the PAI was to determine whether the facility has a quality system that was designed to achieve sufficient control over the facility and commercial manufacturing operations and evaluate the facility’s Good Manufacturing Practice (GMP) compliance. In sum, the Relator alleged factual support for potential FDCA violation.

FDA Approval 72

FDA Approval Manufacturing Compliance Contamination 72

pharmaphorum

OCTOBER 7, 2020

The Pharmaceutical Microbiology Conference East Coast Virtual Conference will be commencing on 28th and 29th October 2020 and will focus on technological developments that push innovation and tackle the most pressing challenges in the world of pharmaceutical microbiology. María José (Pepa) Lopez Barragán is a former U.S.

Contamination 52

Contamination Production Manufacturing Compliance 52

XTalks

FEBRUARY 21, 2022

The BioNTainers will not only be equipped to manufacture BioNTech’s COVID-19 vaccine, but also other mRNA vaccines to address the needs in Africa, such as BioNTech’s investigational malaria and tuberculosis vaccines if they reach successful development and approvals.

Vaccination 105

Vaccination Vaccine Production Manufacturing 105

Roots Analysis

APRIL 15, 2024

It is worth noting that, any discrepancies encountered at this stage of manufacturing can lead to microbial contamination, subsequently resulting in loss of product, long development timelines and substantial financial burden for the drug developers, owing to the high cost of cell-derived raw materials.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

Roots Analysis

JANUARY 12, 2023

Over the years, several advanced and innovative automation tools and technologies have been developed; these have been demonstrated to hold the potential for significant reduction in the cost associated with the manufacturing of advanced therapy medicinal products, thereby, making such products more affordable.

Manufacturing 40

Manufacturing Production Contamination Medicine 40

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. This is extremely important for injectable medications.

Drug Delivery 40

Drug Delivery Contamination Drugs Production 40

FDA Law Blog

OCTOBER 31, 2021

The product or packaging is part of, and in compliance with, a program established on or after January 1, 2022, governing the recyclability of that product or packaging and the director of CalRecycle determines that it will not increase contamination of curbside recycling or deceive consumers.

Packaging 52

Packaging Packaging Containment Production 52

Delveinsight

SEPTEMBER 8, 2021

From discovery to development and production of any biological product, aid in decision making is given by Pharma Consultants. A pharmaceutical consultant provides companies with expert advice on pharmaceutical development and sales. Different areas where Pharma Consultancies provide aid are: Business Development.

Marketing 52

Marketing Production Sales Life Science 52

Roots Analysis

MAY 24, 2024

In addition, various combination products have been approved / are currently under development for the treatment of various therapeutic indications, such as rheumatoid arthritis, diabetes, psoriasis, psoriatic arthritis and multiple sclerosis. This is extremely important for injectable medications.

Drug Delivery 40

Drug Delivery Containment Contamination Production 40

Pharmacy Checkers

DECEMBER 12, 2019

A majority of inspections resulted in findings of non-compliance. Perhaps most troubling is that when inspectors’ findings included the most severe designation, called Official Action Indicated, the FDA’s Center for Research and Development (CEDR) downgraded that determination to Voluntary Action Indicated.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

The Pharma Data

FEBRUARY 18, 2022

The company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals.

Manufacturing 40

Manufacturing Vaccination Vaccine Production 40

Roots Analysis

SEPTEMBER 20, 2023

Further, the development of cell therapy products require a robust population of cells that can be subjected to genetic alterations, without being damaged in this process. In addition, the technology platforms used for the development of such advanced therapy medicinal products (ATMPs) need to be approved by regulatory authorities.

Manufacturing 40

Manufacturing Production Contamination Gene Therapy 40

The Pharma Data

NOVEMBER 18, 2020

Services for safely containing, emptying, transporting and treating human waste, and preventing pits and septic tanks from contaminating groundwater and open drains are needed, but without regulation, investments will not prioritize public health outcomes. and improve public health.

Regulation 52

Regulation Compliance Contamination Marketing 52

XTalks

MAY 13, 2022

This involves careful selection and development of packaging systems with considerations of stability, storage, accelerated aging, freeze-thaw, altitude, drop, vibration distribution simulation, as well as identification and characterization of compounds released from packaging materials (i.e. shaking, changes in pressure, etc.).

Packaging 98

Packaging Packaging Containment Production 98

The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. Shah previously served as Chief Executive Officer and a member of the board of directors of BioMotiv, an accelerator company aligned with the Harrington Project for Discovery & Development, a U.S.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

Cloudbyz

AUGUST 19, 2024

Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market. Compliance with their regulations is mandatory for manufacturers seeking to market their devices globally. What is the purpose of a Design History File (DHF) in medical device development?

Compliance 52

Compliance Manufacturing Regulation Marketing 52

FDA Law Blog

MAY 19, 2023

Labeling Special Controls The labeling may seem like the easiest Special Control for demonstrating compliance. As we stated previously, this submission took well over nine (9) months to review and develop the Special Controls. After reviewing the Special Controls, we understand what took so long.

Reagent 40

Reagent Genetics Contamination Marketing 40

pharmaphorum

AUGUST 4, 2022

Training and development. Staff development and training programmes were largely on pause during the pandemic. Businesses need to ensure they prioritise the recruitment and development of staff to help ensure longevity and survival. Embrace mobile learning.

Development 98

Development In-Vitro Manufacturing Compliance 98

Pharmaceutical Technology

MAY 17, 2023

One big challenge is contamination. It can cost millions of dollars to remove contamination from a manufacturing process and this causes a consequent delay to the preparation of the drug. As with contamination, variation in outcomes and product quality are often a result of the raw materials used.

Insulin 130

Insulin Production Manufacturing Contamination 130

FDA Law Blog

DECEMBER 13, 2021

Subpart E of the PSR was specifically developed to address agricultural water quality control. In 2017, in an effort to lighten the burden for affected parties, FDA proposed to extend compliance dates until at least Jan. Despite opposition, FDA finalized the proposal to extend the compliance dates in March 2019.

Compliance 52

Compliance Contamination Regulation Development 52

Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022. billion by 2028.

Manufacturing 130

Manufacturing RNA Contamination Vaccination 130

Roots Analysis

FEBRUARY 1, 2024

Cold chain is a three-fold concept, involving certain aspects that can be co-related to science, technology, and process development. The concept of temperature controlled packaging initiated in 1817 in England, when the first commercial cardboard box was developed. Microbial contamination due to poorly maintained freezers and fridges.

Packaging 40

Packaging Packaging Containment Production 40

Roots Analysis

OCTOBER 16, 2023

It involves the separation of unwanted particles from biological materials to obtain contaminant free products. Biopharmaceutical filtration systems are designed to remove impurities and contaminants, to improve safety, purity and shelf life of the product. Particle Removal: This is the primary function of these filtration systems.

Bacteria 40

Bacteria Production Protein Contamination 40

Advarra

MARCH 31, 2023

This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

Engineer 52

Engineer Genetics Clinical Research Research 52

The Pharma Data

OCTOBER 30, 2020

Representatives of the legal department and the Department of Compliance, Risk Management, and Ethics (CRE) briefed the members on their roles and responsibilities. The Ethics Officer from CRE provided the Members and Advisers with an overview of the WHO Declaration of Interest process. Diagnostics, therapeutics, and vaccines 10.

Regulation 52

Regulation Vaccination Vaccine Compliance 52

FDA Law Blog

MARCH 9, 2025

The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY.

Cosmetics 59

Cosmetics Compliance Contamination Regulation 59

XTalks

JANUARY 28, 2025

It outlines the main touchpoints, including the earliest stages of technical transfer and new product introduction, through formulation development and scalable manufacture, and finally ensuring that these potent products are packaged in a safe environment before global distribution to clinic or market.

Manufacturing 52

Manufacturing Development Contamination Production 52