GMPSOP

APRIL 3, 2023

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

pharmaphorum

MAY 25, 2022

When events moved online, societies and associations recognised the wider access afforded by “virtual”, and now, as the world slowly gets back on track, many have opted for a hybrid model that offers the best of both. Here, we take a look at the top five takeaways from the document: 1. The same cannot be said for online events.

Documentation 105

Documentation Communication Pharmaceutical Manufacturing Labelling 105

pharmaphorum

APRIL 28, 2021

Experts to come together for compliance event . The complimentary online event, hosted by PRISYM ID, will explain best practice in the implementation of validation ready, cloud-based, global labeling systems. . . The post Experts to come together for compliance event ‘validation ready’ global labeling systems appeared first on.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Express Pharma

OCTOBER 6, 2024

Organised by AmpleLogic, the event aimed to inspire innovation and address challenges in pharmaceutical operations. The event commenced with key industry leaders sharing insights on digital transformation in pharma. The event also recognised Bhaskar Reddy Pabbatireddy for his contributions to AI-driven quality assurance.

Documentation 105

Documentation 105

GMPSOP

OCTOBER 16, 2022

Table of Contents Good documentation practice requires a system for control, implementation, maintenance and archival of GMP related documents and records. To implement good documentation practice and systems the site must assure that GMP documents and records are adequate, approved and in compliance with applicable GMP requirements.

Documentation 40

Documentation Data Entry Communication Packaging 40

FDA Law Blog: Biosimilars

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

Express Pharma

SEPTEMBER 19, 2024

This year’s event will be the largest edition to date, featuring over 500+ technology suppliers from 14+ countries. The triad event aims to create a transformative experience for the pharmaceutical, analytical, biotechnology, and R&D sectors. 

Packaging 105

Packaging Documentation 105

pharmaphorum

DECEMBER 10, 2020

FDA reviewers have already concluded that the vaccine is safe and effective in a briefing document ahead of the Vaccines and Related Biological Products Advisory Committee’s meeting.

Vaccines 103

Vaccines Documentation 103

The Happy PharmD

OCTOBER 26, 2022

All events that jeopardized a patient’s safety, such as those involving falls, wrong surgical sites, clinical alarm mishaps, and other safety-related problems could result in a sentinel event. They were called sentinel events because of the immediate need for attention to address these errors. Every case was a sentinel event?

Hospitals 52

Hospitals Pharmacy Technician Labelling Medical Records 52

Pharmacy Times

NOVEMBER 15, 2024

IVIG was found to cease development of new lesions and heal previously documented erosions without adverse events to the patient or fetus.

Documentation 52

Documentation 52

European Pharmaceutical Review

APRIL 10, 2024

The regimen may be applied as a quality indicator fulfilling certain ISO quality control criteria, and offers “documented, systematic feedback”. Additionally, a laboratory could assume that a partially degraded nucleic acid “is a consequence of upstream preanalytical events rather than contamination in their laboratory”.

Documentation 96

Documentation 96

GMPSOP

JANUARY 29, 2025

users, raw materials, components, intermediates, finished products, departments, facilities, equipment, documents, batch numbers, test methods, specifications, processing lines, suppliers, and many more items as required). – Appropriate controls over systems documentation. The 21 CFR Part 11 also tells us that: i.

Documentation 94

Documentation Process Improvement Pharmaceutical Manufacturing 94

Express Pharma

JUNE 13, 2023

The theme for this year’s annual flagship event is ‘Patient Centricity: New Paradigm of Manufacturing and Quality’. This will be followed by the release of IPA’s Best Practices document.

Documentation 98

Documentation 98

Drug Channels

DECEMBER 2, 2021

Dr. Gottlieb documents—with great specificity—how and why our government’s public health infrastructure failed us during the pandemic. Click here to learn more and register for this event. I suggest Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic , by Scott Gottlieb, M.D. Amazon link). to 1:30 p.m.

Documentation 75

Documentation 75

GMPSOP

AUGUST 10, 2023

Scope : This procedure applies to the training and development of all personnel within a GMP site including the documentation and retention of training records. Procedure Originator is responsible for determining who requires training on Document Change Notification (DCN). Annual refresher training shall be documented.

Documentation 74

Documentation Communication 74

Express Pharma

JUNE 12, 2024

The participants can gain deeper insights on recent focus areas such as Quality Management Maturity Models, Data and Documentation Imperative and Talent Capability Building. Guidance documents on Good Engineering Practices and Process Analytical Technology (PAT) in Orals Solids and API will also be released at the Summit.

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing Documentation 105

pharmaphorum

JANUARY 6, 2023

Kelly Traverso, vice president, Veeva Vault Safety Strategy, and consulting, predicts that “in 2023, companies will broaden their focus beyond safety data to include all the content and documents that come with it. Improved control reduces the risk of misinformation, or having teams send outdated or incorrect information to partners.”.

Documentation 111

Documentation Drug Development Diabetes 111

European Pharmaceutical Review

JUNE 12, 2024

MBK-01 demonstrated a greater clinical benefit than fidaxomicin when used as the first choice for treatment of the current CDI episode event without any antibiotic treatment. Additionally, MBK-01 did not increase the frequency of adverse events (AEs) commonly associated with CDI or antibiotic treatment and was well tolerated.

Documentation 111

Documentation Labelling Hospitals 111

pharmaphorum

OCTOBER 12, 2022

Facilities can be asked to provide documented records of environmental monitoring, as well as personnel interaction with systems of record and the order in which events occurred. Presentation of data is vital when regulators carry out formal inspections.

Documentation 105

Documentation Pharmaceutical Companies Pharmaceutical Companies 105

FDA Law Blog: Biosimilars

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

Documentation 108

Documentation Vaccines Drug Development 108

Express Pharma

JANUARY 16, 2024

The ADR i.e. DRESS syndrome, mentioned in the IPC alert, is a very rare event that is previously documented in medical literature, both in India and globally. The company said mefenamic acid, apart from India (as meftal and meftal-spas) is being prescribed in countries like the USA, the UK, Japan etc.

Adverse Reactions 105

Adverse Reactions Documentation 105

pharmaphorum

JULY 15, 2022

The just-published final technology appraisal document recommends that Vazkepa (icosapent ethyl) can be prescribed to people in England and Wales for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides (1.7 mmol/litre or above) in their blood who are already taking statins.

Documentation 98

Documentation Diabetes 98

pharmaphorum

SEPTEMBER 23, 2020

That’s according to the team at Sweden’s Sahlgrenska Science Park, who are getting ready to host a virtual event looking at how the specialisation of digital expertise is driving a trend of sector convergence that pharma is only just cottoning on to. Innovation versus regulation. For more information visit the Park’s website.

Documentation 140

Documentation Communication Hospitals 140

pharmaphorum

NOVEMBER 11, 2022

According to court documents, Cohen reached out in 2015 to Moshe Alafi, former general partner at Alafi Capital who he had known for decades – and his son Christopher Alafi, who is the firm’s capital director – to seek investment in Nuredis. .

Documentation 113

Documentation 113

Pharma Leaders

MAY 31, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 40

Documentation 40

European Pharmaceutical Review

JANUARY 19, 2023

The final appraisal document (FAD) recommended the triple regimen as an option for adult patients who have received two or three lines of therapy. Adverse events (AEs) observed in the ixazomib arm were consistent with reported safety profiles for the individual agents.

Hospitals 96

Hospitals Documentation 96

Pharmaceutical Business Review

JULY 30, 2024

Notably, the trials reported minimal adverse events. The gastrointestinal adverse events documented for ZUNVEYL were less than two percent, and no cases of insomnia were reported. The efficacy of ZUNVEYL is supported by three bioavailability studies in healthy adults.

Documentation 64

Documentation 64

Express Pharma

DECEMBER 11, 2023

These events are strategically designed to unlock new opportunities and navigate the intricacies of this evolving landscape. In this article, we delve into the highlights of the Chandigarh Pharma Summit 2023, and showcase the key takeaways and insights from the presentations and discussions at the event.

Packaging 104

Packaging Communication Documentation 104

Putting Patients First Blog

APRIL 8, 2025

The FDA should require that sponsors document mechanisms for post-market surveillance, root-cause investigation of errors or malfunctions, and audit trails that track data inputs, model updates, and user interactions. 56 ,57 ,58 Finally, comprehensive documentation is essential for reproducibility and public confidence.

Documentation 52

Documentation Labelling Communication 52

PharmD Live

JANUARY 22, 2025

Tasks such as billing, coding and documentation consume valuable time and resources, pulling focus away from direct patient care. Medication-related issues, such as adverse drug events (ADEs) and nonadherence, further complicate care delivery. To stay viable, physicians must optimize revenue streams without compromising patient care.

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Medication Therapy Management (MTM) Hospitals Documentation Communication 59

pharmaphorum

OCTOBER 7, 2022

As we enter October and the Frontiers Health 2022 conference in Milan, we’re shining a spotlight on some of the Steering Committee members who have helped make the event what it is. And check out DTx and National Health Systems from last year’s event below. A cooling off in digital health investment. “Yet,

Documentation 98

Documentation Diabetes 98

European Pharmaceutical Review

AUGUST 3, 2023

Rather than focusing on documentation with the aim to achieve compliance, the initial proposed framework shined a light on problem-solving and therefore the initiation of preventative action as a key part of the process. These results are included in most recent paper.

Documentation 52

Documentation Process Improvement 52

Express Pharma

JUNE 2, 2023

By accurately documenting the movement of drugs, manufacturers can identify any quality issues that may arise during production, storage, or transportation. Quality control and regulatory compliance: Traceability is crucial for maintaining quality control and ensuring compliance with stringent regulations in the medicine space.

Adverse Reactions 103

Adverse Reactions Packaging Documentation Dosage 103

GMPSOP

JULY 14, 2024

This article provides an in-depth look at how you, as a professional in a GMP business, can prepare quality planning documentation, especially from the perspective of a medical device manufacturing business. Additional documents included each month. Documentation control b. Additional documents included each month.

Documentation 59

Documentation Customer Service Health and Personal Care Stores Communication 59

Pharmacy Joe

MAY 1, 2024

Furthermore, even in the event of a true and serious allergy to penicillin, cross-allergenicity with cephalosporins is low and the reaction is mediated by B-cell memory which fades over time, often within 10 years. The documented allergy was severe in nature for 13% of patients, moderate for 43%, and unknown for 44%.

Inpatient 98

Inpatient Medical Records Documentation Labelling 98

FDA Law Blog: Biosimilars

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment.

Labelling 64

Labelling Communication Documentation 64

pharmaphorum

JUNE 2, 2021

The document – which is available in digital or paper form – will be “free of charge, secure and accessible to all,” according to the European Commission, and may be scanned at the point of departure or arrival within the EU. .”

Vaccines 96

Vaccines Documentation 96