The Social Pharmacist

JULY 28, 2022

So, it ensures that you always have a steady stream of content posted as evergreen content, such as blog posts, podcasts, and videos. . However, typing hashtags manually or copying and pasting them from another document takes time to add them to your posts. Scheduling allows you to plan your social media content. Hashtag groups.

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The Social Pharmacist

JULY 28, 2022

So, it ensures that you always have a steady stream of content posted as evergreen content, such as blog posts, podcasts, and videos. . However, typing hashtags manually or copying and pasting them from another document takes time to add them to your posts. Scheduling allows you to plan your social media content. Hashtag groups.

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Labelling Customer Service Documentation 52

Omnicell

JANUARY 10, 2023

Interoperability shifts these behaviors, allowing nurses to: Locate alternative medication storage areas Remotely document waste Remotely queue medications for multiple patients so one can focus on other tasks After nurses review the MAR for available medications, they can communicate with the pharmacy through PowerChart. Subscribe today.

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The FDA Law Blog

OCTOBER 18, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023.

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ISPE

SEPTEMBER 14, 2023

ISPE GAMP SIG MES Planning to Move the Industry Forward Trudy Patterson Thu, 09/14/2023 - 11:49 iSpeak Blog iSpeak ISPE GAMP SIG MES Planning to Move the Industry Forward Christian Woelbeling Dirk Sweigart, BSME, BSCS, MBA Mark J. Watch the ISPE iSpeak Blog page for future updates.

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Documentation 98

ISPE

APRIL 12, 2023

A Closer Look at Paperless Validation’s Impact on Biotech Trudy Patterson Wed, 04/12/2023 - 07:34 iSpeak Blog iSpeak A Closer Look at Paperless Validation’s Impact on Biotech Steven Thompson 12 April 2023 The impact of paperless validation on the biotechnology industry is massive, and the overall effect is growing as adoption increases.

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The FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). FDA also requests a “detailed description of the allegation with any available supporting documentation.”

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The FDA Law Blog

AUGUST 16, 2023

Document dumps,” he said, are not helpful without the assistance of a narrative placing the documents in context.

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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

MARCH 23, 2023

A True Copy is an exact copy of original documentation that preserves the same content, meaning and attributes of the original. It is an electronic copy maintained in an electronic document management system. However, for higher risk data (i.e., This would satisfy the requirement under PICS section 8.11

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The FDA Law Blog

OCTOBER 16, 2023

In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here ) and whether such plans afford sufficient flexibility for AI/ML developers to innovate and improve products based on new data while also providing sufficient guardrails to ensure patient safety.

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Documentation FDA 119

ISPE

SEPTEMBER 14, 2022

iSpeak Blog. It’s focusing on what matters, which has to be quality instead of compliance and documentation. What about capturing the requirements into a word document versus using a requirements management tool? Documentation alone is no defence against defects. Why We All Need Critical Thinking. Trudy Patterson.

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The FDA Law Blog

JANUARY 10, 2023

An accompanying blog post touts the new Guidance as potentially “one of the most important documents you’ll read in 2022.” Rather, it is “intended to help advertisers comply with the basic tenets of FTC law,” and as stated in FTC’s blog post, “it offers practical perspectives from FTC staff.”

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Documentation 105

Omnicell

JANUARY 10, 2023

The Chief of Anesthesia is now aware of flaws in documentation and has an awareness of open transactions through enhanced data visibility. The Omnicell Blog is the leading source for pharmacy care, exploring emerging trends, successful best practices, and ideas and insights focused on the digital transformation of pharmacy.

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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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PQA

DECEMBER 14, 2023

Strengthen requirements for standardized documentation and reporting related to the quality of MTM services. Increase stakeholder education about the use of the Medication Therapy Problem Categories Framework to assist with standardizing documentation. You can read more about each of these in the draft call to action document.

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Documentation 45

The FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. Lenz, Principal Medical Device Regulation Expert & Lisa M.

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ISPE

AUGUST 17, 2023

The digitization of paper forms and documents has been a crucial first step in this process, but now we are seeing a shift towards the electronic generation and management of data. For one, electronic data can be stored and accessed more easily than physical documents.

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Fossil Remedies

APRIL 26, 2022

If yes, then there are some tips in this blog. Gather all documents. Documentation is an important, essential, and unavoidable step. When a PCD pharma business is launched, you need some documents mandatorily. The Drug License Number and GST Number are these two documents. The first thing is a market research.

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Documentation 59

The FDA Law Blog

OCTOBER 14, 2022

The December 2021 draft guidance document sets forth a pathway for unapproved medical devices to obtain permanent marketing authorization. We previously blogged on this guidance document here.

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ISPE

APRIL 19, 2023

This strategy, and which test is susceptible to carry it out or not, must be set out in a document and this activity corresponds to the PM. It is an essential document for all team members to know the strategy: who must be involved at what time, the scope of qualification, and which test has to be performed in each system/team/service phase.

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Documentation Communication 52

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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Impact Pharmaceutical Services

OCTOBER 27, 2023

Poor documentation. Accurate and complete regulatory documentation is vital to IND application success. The only way to avoid this roadblock is by taking the time necessary to prepare complete, comprehensive, and accurate documentation that follows all existing guidelines for each submission component.

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Documentation FDA 52

pharmaphorum

JANUARY 13, 2021

The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records. Since then the agency has been investigating the incident involving the theft of documents that formed part of BioNTech’s filing for the BNT-162b vaccine.

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Omnicell

JANUARY 10, 2023

So why, as clinicians, are we not focused on improving the documented one in 10 inaccuracies in sterile compounded products? It’s well documented that manual processes are archaic and inaccurate, and organizations like ISMP, ASHP, and many others agree things need to change. Or the airlines lost 10% of passenger bags.

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Sterile Compounds Compounding Omnicell Documentation 52

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. We have recently blogged on this topic (“ Is my software a medical device? ”). Per section 3305(e) of the Omnibus, FDA must provide an updated guidance document by December 2024. We look forward to it.

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The FDA Law Blog

FEBRUARY 7, 2023

In practice, a standard operating procedure for design controls is developed to describe how medical device design will be performed and documented. First, a design history file includes many documents that must be submitted as part of a 510(k), De Novo, or premarket approval (PMA) application.

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The FDA Law Blog

OCTOBER 26, 2023

Walsh — In our June blog post , we reported on FDA’s request for comments about its program to receive information from the public alleging misconduct by other companies. name and model of medical device and detailed description of the allegation with any supporting documentation) versus non-required.

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The FDA Law Blog

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. The new § 820.10

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The FDA Law Blog

DECEMBER 4, 2023

Pharmacists and pharmacy management should pay heed to these prescribing red flags, resolve them when they appear and document their resolution. The order also enjoins the pharmacist-owner from serving as a PIC at any other pharmacy for seven years. Consent Agreement and Final Judgment ¶ 17.

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The FDA Law Blog

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Reducing Disparities in Health and Health Care FDA introduced a new section in the guidance document focused on reducing disparities in health and healthcare.

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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

NOVEMBER 6, 2023

Compared with the COVID-centered version of the document released in April 2021, there is very little that is new or different. RIEs will require the facility to accommodate the “use of teleconference, livestream video, and screen sharing of data and documents.” We should explain what RIEs are.

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The FDA Law Blog

MARCH 7, 2023

Lack of compatibility with cloud-based document sharing. Creation of unnecessary documents. There is no option to reference a document that has already been attached elsewhere in the submission. This may result in the need to create additional documents that you may not necessarily need under the quality system.

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Documentation FDA Communication 59

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 6, 2024

We’ve blogged previously on the troubles FDA has faced ramping up its foreign inspections program after the pandemic. PM Counsel John Claud to testify yesterday about FDA’s foreign inspection program. Mr. Claud frequently counsels foreign and domestic clients on issues relating to inspections and cGMP remediations.

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FDA Documentation 52

Omnicell

JANUARY 10, 2023

Medication management automation , supported by perpetual inventory management and tracking, can provide the visibility needed to track vaccine storage and document administration data across multiple locations. The good news is that there may already be solutions embedded in your health system.

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