ISPE

NOVEMBER 1, 2022

2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. 2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. Quality and Stability. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Quality, Defined.

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FDA Insurance Chemotherapy Documentation 98

ISPE

MARCH 3, 2023

As technologies continue to evolve and are being adopted by the pharmaceutical industry at the same time when companies are facing new challenges like pandemics, supply chain issues and drug shortages, it has become even more important that validation approaches smartly address the risks to Patent Safety, Data Integrity, and Product Quality.

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Documentation FDA 98

ISPE

NOVEMBER 23, 2022

ISPE’s regulatory volunteer groups are charged with bringing visibility and solutions to major challenges faced by the industry with regard to regulatory/quality matters, and facilitating the flow of information between ISPE members and global Health Authorities. A presentation on ISPE’s Pharma 4.0®

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FDA Documentation 52

ISPE

APRIL 12, 2023

Validating absolutely everything is highly inefficient and does not take advantage of the critical thinking-based benefits of computer software assurance (CSA). Quality teams — Standardized documentation and SOP enforcement mean they can operate more efficiently and have greater confidence in their work. 1 Weeks, L.

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Documentation FDA 98

ISPE

SEPTEMBER 1, 2023

1 Important to Note: In the context of industrial processes and manufacturing, plant process management (PPM) refers to the systematic planning, implementation, and control of processes to ensure efficiency, quality, and productivity in a production environment. Integrity is about how accurate and complete the data is.

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Communication Documentation 98

IDStewardship

APRIL 13, 2023

CMS is charged to develop and optimize guidance for improving infection control standards across healthcare settings. This topic alone could be a whole series of blog posts, so I will cut it here, but ask you to consider – should antimicrobial stewardship programs live within pharmacy departments as they so often do today?

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Hospitals Documentation Communication Patient Care 236

The FDA Law Blog

APRIL 25, 2023

We have recently blogged on this topic (“ Is my software a medical device? ”). The Special 510(k) Program Guidance provides an example of a change involving the addition of wireless control capabilities to a bilevel positive airway pressure (BiPAP) device intended to treat patients with obstructive sleep apnea.

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FDA Documentation Labelling Communication 105

ISPE

DECEMBER 13, 2022

Topics such as cell and gene therapies, advanced therapeutic medicinal products (ATMPs), barrier and isolator technology, single-use components, aseptic quality risk management (QRM), aseptic fill/finish, contamination control strategy (CCS), revisions to Annex 1, and more will all be covered.

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Dosage FDA 52

ISPE

JULY 24, 2023

Who is allowed to view the data, how is access controlled, and what protections are in place to prevent unauthorized entities from breaking into the system? Corrupt or deliberately altered data put plants at risk for safety incidents, product quality issues, or other problems within the plant.

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Communication Documentation 98

Policy Prescription

MAY 28, 2021

NeedyMeds , a non-profit organization known for providing patients with help in finding pharmaceutical company-sponsored prescription assistance programs and other drug savings options, hosted a webinar about drug importation last year called “ Drug Importation: The topic everyone’s talking about.” The featured speaker was, Shabbir J.

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Mail-Order Pharmacies Pharmaceutical Companies Pharmaceutical Companies FDA 52

The Checkup by Singlecare

APRIL 25, 2024

Labeled as a controlled substance , Adderall contains amphetamine and dextroamphetamine. The pre-expiration period reflects when the drug is “stable,” meaning that the strength, quality, and purity are solid. But whether or not it’s okay to take the medicine after the drug’s expiration date is somewhat of a hot topic.

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FDA Controlled Substances Labelling 66

The FDA Law Blog

MARCH 9, 2023

Monaco’s remarks on DOJ’s new material was worth listening to, as she hit on three topics that added some new deep cuts to the DOJ corporate enforcement catalogue. He wrote about the lack of any assurance that FDA would appropriately credit disclosure in a 1999 FDLI article. Inspire a culture of compliance. Classics, all.

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FDA Controlled Substances Documentation 52

ISPE

NOVEMBER 3, 2022

Real-time control processes exist now for bioprocesses, artificial intelligence (AI), and “super computers” to maintain process control, so potentially gene therapy production could be automated. Manager, Biotherapeutic Quality Division. State Institute for Drug Control. Convergence and More. Lead Scientific Officer.

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Communication FDA Documentation Vaccines 98

Viseven

OCTOBER 26, 2022

Within the pharma industry, many risks exist concerning drug approval, quality control, and the supply chain. Companies can collect data at several levels, such as maintenance, production, and quality service—all of these need to be digitized and then exploited to resolve operational challenges in pharmaceutical industry.

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Hospitals Vaccines Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 10, 2023

However, their arrival requires reconsiderations on risks, quality assurance, and validation from a GxP perspective. We will examine this question from quality, risk, and efficiency perspectives and discuss how such tools can shift the way we think about validation and quality assurance.

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Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

NOVEMBER 10, 2022

We need affordable treatment cost, accessibility for global patients, and the most effective and high quality products delivered to patients in the fastest possible time! What is your vision for the industry? It’s been nearly 5 years since the first CAR-T therapy for cancer was approved by the US Food and Drug Administration.

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Documentation Compounding Hospitals Immunization 98

European Pharmaceutical Review

FEBRUARY 23, 2023

Despite this overlap, this article addresses the main challenges for industry and firms, and those for pharmaceutical microbiologists, separately, focusing on some of the difficult and often overlooked hurdles relating to quality assurance (QA) and quality control (QC) of licensed and marketed pharmaceutical drug products.

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Dosage Vaccines 94

ISPE

JUNE 21, 2023

These systems were designed specifically to support validation or quality objectives. While a very nuanced conversation, I see struggles occur most often across the organizations that disagree on what ‘documentation’ should exist, ‘who and what’ constitutes quality reviews, and, of course, the demand for resourcing in time, people, and money.

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Documentation Data Entry Compounding FDA 52

ISPE

JULY 6, 2023

Q13 Scope The intent of Q13 is to build on existing ICH quality guidelines while providing clarification on CM concepts. A key thrust of the guidance is to highlight when concepts that are unique to CM need to be part of the regulatory filing versus appropriately captured within each companies’ pharmaceutical quality system (PQS).

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Documentation Dosage FDA Pharmaceutical Companies 52

ISPE

OCTOBER 27, 2022

Driving the transition to the digital world through the quality and validation lenses. This blog is the first in a 4 part series intended to explore how we can rethink the way we support and inspire one another as we reimagine quality and validation in a digital world. Walker, CPIP. 27 October 2022. A few key steps. Be the change.

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Documentation 52

pharmaphorum

OCTOBER 7, 2020

SMi Reports: An exclusive interview with María José López Barragán, Founder, Barragan BioConsulting, formerly CMC Product Quality Reviewer, FDA, who will be speaking at the 3rd Annual Pharmaceutical Microbiology East Coast Conference released. María José (Pepa) Lopez Barragán is a former U.S.

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FDA Pharmaceutical Companies Pharmaceutical Companies 52

Board Vitals - Pharmacist

JANUARY 6, 2023

Upon first renewal, requirements include one hour in HIV/AIDS, professional and medical ethics, Florida laws and rules, and controlled substances, as well as, two hours of domestic violence and medical errors prevention. However, physicians are required to attend a mandated training related to infection control every four years.

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Controlled Substances Documentation 59

ISPE

SEPTEMBER 11, 2023

Cauchon, PhD 1 September 2023 The biopharmaceutical industry must develop and implement innovative ways of working to be effective and efficient in the current healthcare ecosystem, in which high-quality medicines, adaptability, and assurance of supply are of critical importance.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

SEPTEMBER 12, 2022

Director, Office of Pharmaceutical Quality Operations. Deputy Director, Office of Manufacturing Quality. Director External Engagement and Supplier Quality. What controls need to be considered when patient-specific manufacturing has multiple products and different viral vectors in the same room? Panelists: Alonza Cruse.

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FDA Documentation Communication 52

The Thyroid Pharmacist

SEPTEMBER 15, 2023

In this article, we explore: The thyroid and perimenopause connection Symptoms of low progesterone Strategies to naturally raise progesterone levels How to use topical progesterone to balance hormones The Thyroid and Perimenopause Connection Perimenopause refers to the time that the body starts making the transition to menopause.

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Health and Personal Care Stores Dosage Compounding Immunization 56

The Physician Pharmacist

JULY 30, 2022

This may also change if you are apply via the Early Assurance Program (EAP). So how do you broach this complicated topic with your preceptor? These shortcomings include controlling attitudes, arrogant or dismissive behavior, and major social awkwardness. These are qualities that can lead to a quick rejection.

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Medical Schools Communication Documentation Patient Care 52

ISPE

AUGUST 30, 2022

Finally, the DP is packaged in a suitable container to ensure continued quality. Case studies are presented that demonstrate the importance of defining the raw material attributes that are critical to product quality and how this could support increased postapproval flexibility (including the use of ICH Q12 principles).

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Documentation FDA Packaging Communication 52

The Thyroid Pharmacist

JANUARY 6, 2023

Depression is a topic near and dear to my heart. times higher among patients with hypothyroidism compared with healthy controls.” (2). Oftentimes, a deficiency in a key nutrient results in many of the symptoms associated with depression, and supplementing with a quality supplement can make all the difference in improving mood.

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Dosage Labelling Communication FDA 119

ISPE

MARCH 7, 2023

Practical challenges of working across multiple organizations and countries are discussed together with the growing expectation for independent audit and assurance of claimed benefits delivery. antimicrobial resistance), effects of pollution on air quality, and a focus on biodiversity, including preserving and restoring ecosystems.

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Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

Hospital Pharmacy Europe

JANUARY 18, 2023

The severity of atopic dermatitis and its effect on quality of life is assessed by a variety of scoring systems that include both subjective and objective measurements. 3 A typical treatment pathway involves emollients and topical corticosteroids (first line), topical calcineurin inhibitors (i.e.,

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Hospitals Medical Records Documentation Pharmaceutical Companies 52

The Thyroid Pharmacist

MARCH 10, 2023

They help establish our stress tolerance, tame inflammation, regulate blood sugar and body fat, control potassium and sodium levels (impacting blood sugar), influence libido , and help with keeping us young by ensuring we are in a restorative repair mode… among other things. 3] (For this reason, quality sleep helps reduce brain fog.)

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Health and Personal Care Stores Immunization Packaging Dosage 65