ISPE

AUGUST 15, 2023

This conference will host six tracks on two significant topics for the pharmaceutical industry: 1) Pharma 4.0™ This conference will host six tracks on two significant topics for the pharmaceutical industry: 1) Pharma 4.0™ This approach not only enhances product quality by avoiding disruptive turbulence from high air velocity at 0.45

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Board Vitals - Pharmacist

FEBRUARY 9, 2024

By taking the time to study some often overlooked topics, you will be ready to do your best come test day. What topics are on the Radiology Core Exam? basis for quality control of the various nuclear medicine agents. The post 5 of the Most Overlooked Topics on the Radiology Core Exam appeared first on BoardVitals Blog.

52

52

PQA

JUNE 12, 2023

PQA has released an updated Medication Use Quality continuing education program. The updated courses divide the previous 15-hour Medication Use Quality certificate into a more flexible program for busy professionals. The program will meet quality professionals where they are at.

52

52

ISPE

AUGUST 30, 2023

™, Quality Risk Management (QRM), Contamination Control Strategy (CCS) and Annex 1, Facility Design and Operations, Artificial Intelligence and Machine Learning, and Professional Development. Participants will learn about the revisions of Annex 1 and hear about the changes from a Quality Leadership position.

Documentation 98

Documentation Vaccines 98

ISPE

MARCH 20, 2023

The Approach Consequently, this has moved ISPE to address the topics in a Special Interest Group (SIG) within GAMP D-A-CH. Implementation and Quality Gates This new standard provides the tools to ensure data quality in DI critical areas over the entire life cycle of the interface.

Documentation 97

Documentation Communication 97

PQA

JULY 28, 2023

Creating a quality improvement plan can seem daunting to many, but it is vital for value-based care and improved patient quality. They provide in-depth and detailed evidence-based interventions at the patient level to optimize care and identify ways front-line practitioners can optimize care through quality improvement activities.

Community Pharmacies 52

Community Pharmacies Patient Care 52

PQA

JULY 21, 2023

Creating a quality improvement plan can seem daunting to many, but it is vital for value-based care and improved patient quality. They provide in-depth and detailed evidence-based interventions at the patient level to optimize care and identify ways front-line practitioners can optimize care through quality improvement activities.

Community Pharmacies 52

Community Pharmacies Patient Care 52

Pharmaceutical Technology

APRIL 25, 2023

The audit was focused on the quality management systems and platform AAV manufacturing process of the facility. It received orphan drug, fast track and rare paediatric disease designations from the US Food and Drug Administration. Topic sponsors are not involved in the creation of editorial content.

52

52

The Luxe Pharmacist

AUGUST 8, 2023

With that being said, I’d like to place a disclaimer that I know anything surrounding money can be a sensitive topic and this post is in no way meant to brag or boast about my ring. He does truly appreciate all the comments on Instagram telling him he did such a great job and having that much faith in his design eye.

97

97

PQA

MARCH 13, 2023

The Pharmacy Quality Alliance (PQA) is providing scholarships for minority health care professional students to attend the 2023 PQA Annual Meeting, May 10-12, in Nashville, Tenn., and participate in the pre-meeting Medication Use Quality (MUQ) Live workshop on May 10.

Specialty Pharmacies 52

Specialty Pharmacies 52

ISPE

JANUARY 30, 2023

The Ever-Changing Regulatory & Quality Landscape with Aseptic Processing Trudy Patterson Mon, 01/30/2023 - 10:54 iSpeak Blog iSpeak The Ever-Changing Regulatory & Quality Landscape with Aseptic Processing Michael G. Tim Dreckmann from F. Hoffmann-La Roche Ltd. This has undoubtedly saved countless lives.

FDA 80

FDA 80

PQA

AUGUST 29, 2022

As experts in measure development, research, education and convening, they lead the implementation of PQA’s quality initiatives to support better medication use and high-quality care. She provides expertise and support for research projects that advance the quality of medication use. What is your role at PQA?

Community Pharmacies 52

Community Pharmacies 52

ISPE

JULY 21, 2023

The seminar was organized with opening keynote and plenary presentations followed by three tracks, one for each of the above topics with closing plenary sessions. The seminar was organized with opening keynote and plenary presentations followed by three tracks, one for each of the above topics with closing plenary sessions.

Documentation 98

Documentation 98

pharmaphorum

JANUARY 4, 2021

Join us virtually, on the LHN virtual event platform to improve your medical writing strategies by understanding evolving regulatory protocols and submission guidelines, and learn how to improve quality and content optimizations. TOPICS TO BE ADDRESSED: Project Management Best Practices for Compliant and Timely project completion.

Communication 64

Communication 64

Pharmaceutical Technology

APRIL 5, 2023

Caribou Biosciences has secured fast track designation from the US Food and Drug Administration (FDA) for its CAR-T cell therapy, CB-011. The newly granted designation helps the firm accelerate the development and evaluation of CB-011. Topic sponsors are not involved in the creation of editorial content.

FDA 59

FDA Communication 59

Hospital Pharmacy Europe

MARCH 12, 2024

adherence, quality of life, patient satisfaction, health literacy); Healthcare systems (e.g. The FIP Foundation supports the education and research of pharmacists and pharmaceutical scientists within the general fields of design, development, manufacture, distribution and responsible use of medicines.

Patient Care 52

Patient Care Hospitals 52

Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals has received fast track and orphan drug designations for RP-A601 from the US Food and Drug Administration (FDA) to treat plakophilin-2-related arrhythmogenic cardiomyopathy (PKP2-ACM). Topic sponsors are not involved in the creation of editorial content.

FDA 59

FDA Communication 59

The Checkup by Singlecare

APRIL 25, 2024

Topical capsaicin products can relieve joint pain and other arthritis symptoms , but even when taken orally—as a supplement or added to your recipes—capsaicin has the potential to enhance many of your body’s normal functions, like digestion, circulation, detoxification, and immunity to disease. the basics!).

Dosage 111

Dosage Immunization Compounding 111

ISPE

MARCH 16, 2023

We will also address the ways in which these approaches can help to improve adherence to new Annex 1 and the overall quality and safety of pharmaceutical products. During the 2023 ISPE Europe Annual Conference , you will have the opportunity to explore all these topics in details.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation Dosage 98

The FDA Law Blog

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. In case you do not have time to watch the town hall , we provided a summary of select topics that are discussed below.

FDA 59

FDA Labelling 59

Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has given orphan drug designation to SiSaf’s siRNA [a double-stranded RNA molecule that is non-coding] therapeutic, SIS-101-ADO, for the treatment of autosomal dominant osteopetrosis type 2 (ADO2), a rare and serious skeletal disorder in children.

FDA 52

FDA 52

ISPE

MARCH 30, 2023

or the “Smart Factory”, as applied to the Pharmaceutical Industry) have reaped the benefits of data connectivity – including improved quality, productivity, and profitability. Greenfield facilities that have been the first to embrace the tools of Pharma 4.0 Industry 4.0,

Documentation 98

Documentation 98

Pharmaceutical Technology

MAY 19, 2023

MT-302 is a TROP2-targeting in vivo chimeric antigen receptor (CAR) that has been designed to express in the myeloid compartment. We are pleased that such high-quality investors have joined with us to accelerate this effort.” Topic sponsors are not involved in the creation of editorial content.

Labelling 98

Labelling 98

The FDA Law Blog

NOVEMBER 29, 2023

See our prior blog post on the topic here. Total Product Lifecycle (TPLC) This guiding principle reminds manufacturers that PCCPs and MLMD changes should be integrated into the lifecycle management of the device and be part of their existing quality system processes including but not limited to risk management and post market monitoring.

FDA 115

FDA Labelling Communication 115

pharmaphorum

JULY 22, 2022

This one-of-a-kind meeting will facilitate networking opportunities with key opinion leaders from all areas of pharmaceuticals, biologicals, and cleanroom industry experts to explore hot topics within cleanroom design and engineering, best practices and regulation, environmental and contamination control, and pharmaceutical microbiology.

Compounding Pharmacies 52

Compounding Pharmacies Compounding 52

ISPE

JUNE 15, 2023

Revisions to ISPE GAMP ® 5 and related good practice guidance publications are aimed at providing support and flexibility in the design and implementation of computerized systems at all stages of life sciences product invention, development, and production. ™ paradigm. It is also important to note that “Pharma 4.0™”

98

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.

FDA 52

FDA Documentation 52

PQA

MARCH 10, 2023

The pilots are critical for validating novel measure concepts, by providing assurance that our specifications can be consistently interpreted and applied to effectively measure the quality of pharmacist-provided care and the impact on patients. Save the date for the next PQA Quality Forum Webinar, April 20,1-2 pm ET. Register today!

Community Pharmacies 52

Community Pharmacies Patient Care 52

pharmaphorum

OCTOBER 16, 2020

The trial – run by Boehringer Ingelheim and Yale University – will test a smart bathroom scale device that has cardiac monitoring built in, as well as an app to help patients improve their diet and lose weight and a digital assistant designed to motivate them to actively manage their health.

Communication 111

Communication Hospitals 111

ISPE

NOVEMBER 22, 2022

I presented on planning and executing and designing fill lines, RABS, Isolators, and transfers – along with the differences between processing potent compounds versus non- potent compounds. This is a great forum for connecting and collaborating on technical and career advancement topics.

Compounding 98

Compounding Packaging Dosage Vaccines 98

PQA

MARCH 22, 2023

PQA will bring its members and industry experts together on November 2 to discuss the state of medication therapy management (MTM) practice, implications of recent Centers for Medicare & Medicaid Services proposals and opportunities to evolve MTM quality measurement. from 9:00 a.m.-2:00 million to 11 million.

Documentation 52

Documentation 52

ISPE

SEPTEMBER 8, 2022

The agenda of this content area is designed to discuss the innovation and use of emerging technologies at different stages of facility designs and drug development. The application of patient-centric approaches is a way to improve the drug quality and overall drug development lifecycle. It also enables a robust product supply.

Packaging 93

Packaging FDA 93

pharmaphorum

JANUARY 24, 2022

Ensuring Risk-Based, Safety-Driven, High-Quality Operation. The conference will encompass the critical topics including risk assessment, occupational toxicology, engineering controls for containment, facility design, and the impact of pharmaceutical manufacture on the environment. SMi’s 6th Annual. 9th and 10th May 2022.

52

52

ISPE

MAY 2, 2023

Manufacturing, Quality Control & Operational Excellence Applying harmonized approaches to innovative design solutions and project delivery strategies to ensure that quality therapeutic products are brought to market in an efficient manner to improve patient health. Resources, Organization, Culture, and Information Systems.

98

98

The FDA Law Blog

NOVEMBER 17, 2022

patients are “first in the world” to receive innovative medical devices that are of “high-quality, safe, and effective” through “early, frequent, and strategic communications between the FDA and medical device sponsors.” The TAP Pilot will first focus on CDRH-designated breakthrough devices. Food & Drug Admin., See Announcement.

Communication 69

Communication FDA 69

ISPE

SEPTEMBER 1, 2023

The answer is yes…as long as they are designed with data security in mind. 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.

Communication 98

Communication Documentation 98

ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. However, some of the products manufactured in a topical drug facility can be difficult to clean. Lopolito Steven M.

Method Validation 52

Method Validation Documentation Packaging Compounding 52