XTalks

SEPTEMBER 12, 2022

Food and beverage companies across the supply chain must always be prepared for new regulatory developments in 2022 as they seek to bring new ingredients and products to market. New regulations are often reflective of the supply chain, food safety and consumer trends. Regulating Heavy Metals in Baby Food.

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The Pharma Data

NOVEMBER 18, 2020

The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).

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XTalks

NOVEMBER 2, 2020

The requirements come from two specific FSMA regulations: the Preventive Controls for Human Food (PC Human Food ) and Produce Safety. And under three FSMA regulations, suppliers may also use third-party audits to verify their activities. Related: Is the FDA Doing Enough to Regulate Added Chemicals in Foods?

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XTalks

AUGUST 21, 2020

Michel Nielen, professor of food safety at Wageningen University & Research, in the Netherlands wanted to create a fundamental change in the world of food monitoring, so he and his team coordinated the FoodSmartphone project which is developing ways to detect food quality and safety using smartphones. But it’s not enough. Traceability.

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The Pharma Data

MAY 3, 2021

Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . .

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pharmaphorum

MAY 5, 2022

Assuring end-patient safety through holistic contamination control. With advances in rapid microbiological methods, revised industry regulation, enhanced knowledge of innovative therapies, and novel testing methods, this industry is ever expanding. Sponsored by: Associates of Cape Cod, Bioscience International and Ecolab.

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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. Meeting strict standards.

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pharmaphorum

JULY 22, 2022

for an Improved, Efficient and Contaminant-Free Cleanroom. From the new operating practices that keep the product as sterile as possible, to the developments in technology that are enabling this to happen. Key Reasons to attend: Learn how to maximise the latest cleanroom technologies to modernise your contamination control strategy.

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Roots Analysis

JANUARY 27, 2025

In order to manufacture GMP regulated cell therapies, it is necessary to assess each manufacturing step at regular intervals. The development of cell therapy products requires a robust population of cells that can be subjected to genetic alterations, without being damaged in this process.

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XTalks

DECEMBER 1, 2021

Not only can the PD100 ensure produce is safe to eat, but it can also help users develop better fruit and vegetable washing habits over time. Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? It comes equipped with a wireless charging station and lasts for six hours per charge.

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pharmaphorum

MARCH 22, 2022

The efforts underway to strengthen the manufacturing process across the industry have become more important than ever, as the therapies the industry is developing increase in complexity. However, with a number of deals and investments being made in the space, the demand is there to develop more efficient methods of training and manufacturing.

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XTalks

MAY 30, 2023

The VTT Technical Research Centre of Finland has addressed this issue by developing a fully recyclable, modular ECG patch constructed from VTT’s novel cellulose e-skin material. Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments.

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XTalks

JUNE 14, 2022

Researchers at the Karolinska Institutet in Sweden developed a new nano-sensor for detecting pesticides on produce in a matter of minutes. To overcome this, we developed inexpensive and reproducible nano-sensors that could be used to monitor traces of fruit pesticides at, for example, the store.” .

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XTalks

MAY 13, 2021

Since the material can change color in response to different stimuli, the researchers believe this discovery can also be used to advance the development of anti-counterfeiting technologies and stretchable electronics. “A Related: MIT Scientists Develop Food Sensor That Can Detect Spoiled or Contaminated Food.

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pharmaphorum

JUNE 8, 2022

Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0 Bioprocess Research & Development. Cleanroom Managers. Regulatory Affairs Managers. Production Managers. Quality Systems Managers.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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XTalks

NOVEMBER 2, 2021

It also found detectible levels of phthalates in food handling gloves, which researchers said could be a source of contamination. The study found higher levels of chemicals in fast-food items containing meat, such as hamburgers and chicken burritos, while cheese pizza had the lowest levels.

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XTalks

OCTOBER 21, 2022

The review explains how local health departments can prioritize retail food regulations if unprecedented public health emergencies occur in the future. A contamination at a retail establishment has the potential to greatly impact public health. Routine food safety inspections experienced significant disruptions throughout the pandemic.

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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.

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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.

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XTalks

JUNE 5, 2023

Related: World Food Safety Day 2022: Theme, History and Ways to Get Involved The HACCP system traces its roots to the 1960s, developed initially by the National Aeronautics and Space Administration (NASA) and Pillsbury to provide safe, long-lasting food for space missions.

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FDA Law Blog

JULY 29, 2024

The draft guidance first addresses the kinds of information applicants should develop and collect so that they can evaluate the effects that post-manufacturing changes might have on their products’ identity, strength, quality, purity, or potency. Part 601 delineates those changes as being either major, moderate, or minor.

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FDA Law Blog

NOVEMBER 30, 2022

According to the Realtor, these CIP qualification discrepancies “may lead to contamination” and “…over time [lead to] to adulterated [Gamunex] product and significant risk of patient harm.” These CIP equipment qualification reports were provided to the FDA in support of its PAS and PAI to approve the new facility.

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FDA Law Blog

OCTOBER 31, 2021

SB 343 adds additional requirements; it requires that California’s Department of Resources Recycling and Recovery (CalRecycle) update regulations that require disposal facilities to provide information on recycling data. Instead, companies must be aware of the specific nuances and requirements in California and developments in other states.

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XTalks

JUNE 7, 2021

World Food Safety Day was founded mainly to draw attention to the contamination of food and water, the people it impacts and ways to reduce risks. Recognizing the systemic connections between them and meeting the terms laid out in the UN’s Sustainable Development Goals will help meet the food safety needs of the future, the FAO suggests.

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Pharmacy Checkers

NOVEMBER 21, 2019

As my greater advocacy initiatives have worked to implore the FDA to bring more balance, commonsense and fairness to regulating and providing consumer education about personal imports of prescription drugs, I’ve realized that I should practice the same in how I talk about the FDA. The medications that we obtain in the U.S.,

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Roots Analysis

OCTOBER 24, 2023

Different Types of HPAPIs The new generation of APIs being developed are highly complex in nature, including peptides, HPAPIs, oligonucleotides and sterile APIs. This precaution is taken to prevent any potentially harmful contaminant from escaping the production area.

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Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard. Why do I write “exact same”?

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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.

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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.

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XTalks

MAY 13, 2022

Container closure systems are highly regulated by health agencies. With a network including North America, Europe and Asia, Curia aims to improve patient outcomes and quality of life by offering a complete suite of solutions across its three divisions: Discovery, Development and Analytical (DDA), Drug Product and API Manufacturing.

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Camargo

AUGUST 5, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. This prospectively developed comparative evidence was used to great advantage by Astellas as RWE in its submission for this new approval.

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Cloudbyz

NOVEMBER 3, 2021

Before deploying collected samples for a project, small portions from those samples are retained as a precautionary measure, to account for any potential destruction or contamination of the originally designated portions of the samples. Let’s use the easiest example of a sample. Reflecting, not directly predicting.

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XTalks

MAY 3, 2024

Challenges and Need for Vigilance: Despite explicit cooking instructions on labels, the persistence of Salmonella -related illnesses underscores the necessity for strict regulations. Approximately one in every 25 chicken packages at grocery stores is contaminated with Salmonella. How Common Is Salmonella in Chicken?

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FDA Law Blog

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. 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.

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Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. So, we set out to solve some of the problems,” she explains.

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Pharmaceutical Technology

MARCH 22, 2023

Several drug development trends are driving injectables demand. Yet while demand for injectables soars, regulators are cracking down on quality requirements, forcing many pharma companies to examine the role – and risks – of their primary packaging. Regulators are also paying close attention to the risks.

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