ISPE

SEPTEMBER 14, 2022

iSpeak Blog. introduces it thus: Critical thinking is the intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing, and/or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action.

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ISPE

APRIL 19, 2023

An effective project manager understands the associated processes of the critical systems/equipment under test and is able to identify any issues/misalignments with expectations that may compromise the qualification performance of another system or equipment and communicate/correct them accordingly. For example: 1.

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Pharmacy Is Right For Me

APRIL 4, 2023

To learn about some of the more unique career settings in the industry, check out the Novel Pharmacy Practice Settings page —where you can explore these unique career pathways such as integrated health-community paramedicine. It also improves care coordination and eliminates communication gaps.

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The FDA Law Blog

FEBRUARY 5, 2024

Her expertise includes preparation and maintenance of licensing documentation, communications with state boards and government agencies, conducting research, and the preparation of associated licensing documentation and applications.

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ISPE

FEBRUARY 14, 2023

ISPE’s Regulatory Commenting Process Trudy Patterson Tue, 02/14/2023 - 16:19 iSpeak Blog iSpeak ISPE’s Regulatory Commenting Process Wendy McGhee 14 February 2023 What is Commenting? After a thorough internal review, health authorities sometime release a document for public comment. Tell other interested parties about your comment.

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The FDA Law Blog

JUNE 8, 2023

The pandemic had changed the way people live, work and communicate. CDRH As of this blog post, CDRH has not made any official announcements regarding the resumption of in-person meetings. Advisory Committee Meetings As of this blog post, all Advisory Committee Meetings that FDA has announced will be conducted via an online platform.

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ISPE

DECEMBER 6, 2022

iSpeak Blog. This blog is the second in a series of four 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. Value of getting more information and context outweighs the risk of potentially having a documented path without conclusion.

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The FDA Law Blog

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.

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The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers.

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ISPE

NOVEMBER 23, 2022

iSpeak Blog. Continue active cooperation with strategic partners , encourage PIC/S membership and strengthen PIC/S communications and engagement. Build PIC/S operational capacity by securing new revenue streams, implementing fiscally sound financial plans and increase transparency to the PIC/S community. Trudy Patterson.

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ISPE

SEPTEMBER 28, 2023

Navigating Life Sciences Construction in California Trudy Patterson Thu, 09/28/2023 - 11:40 iSpeak Blog iSpeak Navigating Life Sciences Construction in California Gul Dusi 28 September 2023 Few industries have as deep a footprint in California, USA as life sciences. billion a year.

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Roots Analysis

AUGUST 9, 2023

Integrating advance tools and technologies with manufacturing execution system (MES) ensure smooth communication within different production process, enhance decision making capability of MES and also enhance risk prediction capabilities.

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IDStewardship

APRIL 13, 2023

An important accompanying document for Joint Commission standards are Critical Access Hospital Accreditation Survey Activity Guide, for which the January 2023 guide can be found here. This is a really nice blog post from Nebraska Medicine that gives more details about NHSN AUR.

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The FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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The FDA Law Blog

AUGUST 9, 2023

Two licensed pharmacists must directly communicate the transfer. As with other required controlled substance records, electronic records documenting EPCS transfers must be maintained for two years from the transfer date by both the transferring and receiving pharmacies. cannot be altered during the transmission.

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The FDA Law Blog

OCTOBER 31, 2022

We have followed it over the last five years, with blog posts here , here , here , here , here , here , and here. As part of the testing, FDA retrospectively reviewed applications to determine if the Excellence Appraisal could be used in lieu of certain other premarket software documents. Key Performance Indicators.

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ISPE

JULY 24, 2023

For example, HTTPS should be used for encrypted communication between the web browser and the cloud application, and the system should be designed with multi-tenant architecture to isolate each customer’s data.

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ISPE

MARCH 16, 2023

In this blog, we will briefly explore the challenges and opportunities of digitalized aseptic production, fully contained and automated production and collaborative work with CMOs. Some of these challenges include for example regulatory compliance, quality control and effective communication between the original manufacturer and the CMO.

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The FDA Law Blog

JUNE 20, 2023

The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry. Like other guidance documents that preceded it, the draft guidance will be open to the public for comment. Once final, the guidance will be implemented and review staff will be trained.

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ISPE

SEPTEMBER 1, 2023

For example, HTTPS should be used for encrypted communication between the web browser and the cloud application, and the system should be designed with multi-tenant architecture to isolate each customer’s data.

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The FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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ISPE

MARCH 20, 2023

In context of this blog, an interface is connecting two or more systems, including transport technology and middleware where necessary. The Challenge New approaches and technical possibilities are constantly being developed to enable systems to communicate with each other and exchange data.

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Omnicell

SEPTEMBER 5, 2022

As a leading provider of patient engagement and communications technology solutions for retail pharmacies and health plans, EnlivenHealth® is helping pharmacies to effectively manage the COVID-19 vaccine with its recent launch of CareScheduler , a software as a service technology solution.

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The FDA Law Blog

MAY 11, 2023

Koblitz — Well, we’re a little late to blogging about this, but the significance of the ongoing Teva v. GSK litigation to Hatch-Waxman aficionados makes this case still ripe for blogging. Six months after the Supreme Court asked the Solicitor General to submit a brief on behalf of the U.S.

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ISPE

NOVEMBER 3, 2022

iSpeak Blog. Okudaira of PMDA agreed that communications may be a driving force of acceptance of new models, and also establishing international convergence documents may help. This was successful, he said, and EMA learned that communication is important between regulators. Trudy Patterson. Thu, 11/03/2022 - 13:48.

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The deprescribing.org Blog

FEBRUARY 17, 2021

The key is communicating properly with community colleagues. This helps alert everyone, including the community pharmacist, to the intended changes. If a drug is started, documenting the reason for use is a must. The deprescribing blog is hosted by pharmacists and postdoctoral researchers, Carina Lundby and Wade Thompson.

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Impact Pharmaceutical Services

MAY 4, 2022

As highlighted in these guidance documents, the FDA offers five programs: fast track designation, breakthrough therapy designation, regenerative medicine advanced therapy (RMAT) designation, accelerated approval and priority review designation. Image courtesy of qimono at pixabay.com.

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Omnicell

JANUARY 10, 2023

The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. Disclaimer The views and opinions expressed in this blog are those of the authors. 340B providers expressed significant concern.

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The Happy PharmD

JANUARY 18, 2023

Apply the power of job crafting to create a new job after communicating your strategy for solving a problem in the firm. Doing so will help you properly document your milestones in your resume and mention them during the interviews, even if you do not want to be on Linkedin or network. Recap all you have accomplished in the past year.

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ISPE

NOVEMBER 2, 2022

iSpeak Blog. ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong. Trudy Patterson.

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The FDA Law Blog

DECEMBER 12, 2022

This blog post describes the medical device determination process and a way of assessing software functions to determine if your software product is subject to FDA regulations. It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop.

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The FDA Law Blog

MARCH 7, 2024

The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. Both documents note that FDA may request that the sponsor submit the DMC charter to FDA for review before the performance of any interim analyses, and ideally before the initiation of the trial.

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ISPE

NOVEMBER 21, 2022

iSpeak Blog. All of this must of course be verified as part of supplier evaluation, and the criticality of applications dependent on cloud resources must be clearly stated and agreed in a contractual document. IT Infrastructure in the Current Life Science Company Environment. Trudy Patterson. Mon, 11/21/2022 - 10:06. Christopher J.

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The FDA Law Blog

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

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The FDA Law Blog

FEBRUARY 28, 2023

The general structure of our submissions, and of many others that we have seen, is to have a document for each of the twenty sections and then to refer to other files, such as labeling and test reports, as attachments. Several sections of the eSTAR templates have questions that walk through related guidance documents.

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The FDA Law Blog

FEBRUARY 27, 2023

Helpful practitioner prescribing guidance is set forth in a simplified document here. And, as one who loves easy-to-follow charts… DEA has published one here , setting forth the various general parameters for prescribing via both telemedicine and in-person visits – and covering both the general and buprenorphine telemedicine proposed rules.

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Controlled Substances FDA Documentation Labelling 59

Omnicell

SEPTEMBER 5, 2022

In today’s complicated world, where keeping in touch with your pharmacy customers is more challenging than ever, new patient communications and engagement tools are needed. scheduling for immunizations and point-of-care testing), and improve satisfaction and retention. Visit us at enlivenhealth.co to learn more.

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