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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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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Documentation FDA 98

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In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here ) and whether such plans afford sufficient flexibility for AI/ML developers to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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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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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

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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Documentation Communication 52

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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Documentation 98

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

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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Documentation Communication 52

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

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

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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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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FDA Documentation Labelling Communication 105

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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FDA Documentation 52

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

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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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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Documentation FDA Labelling Communication 45

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

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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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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Vaccines Omnicell Documentation Compounding 52

ISPE

NOVEMBER 23, 2022

iSpeak Blog. He said that PIC/S had identified the need for GMP inspectors to be provided with training and guidance documents on how to evaluate Pharmaceutical Quality Systems, with training material currently being developed. ISPE Represented at PIC/S 50th Anniversary Event. Trudy Patterson. Wed, 11/23/2022 - 06:50. 23 November 2022.

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Documentation FDA Communication 98

The FDA Law Blog

OCTOBER 24, 2023

It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. To learn more about our experience with the eSTAR for 510(k)s, check out our previous blogs ( here , here ).

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FDA Documentation Labelling 52

pharmaphorum

DECEMBER 7, 2022

Reuters said it has interviewed 20 current and former Neuralink employees in its investigation, as well as reviewing internal company documents. In one incident, it alleges, 25 of a cohort of 60 pigs were implanted with devices that were the wrong size, while others include rushed surgeries that have caused needless pain to animals.

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Medical Records Documentation 120

ISPE

FEBRUARY 14, 2023

Background In paper based CQV programs, the inspection process focuses on reports and execution binders; the reports summarize the conclusions of a specific study, and the execution binder provides the documented evidence used to support the conclusions in the report. Can you describe the audit trail features of this application?

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Documentation Packaging 52

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. Attachment number) and document name or description as appropriate.

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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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Controlled Substances Documentation Communication 45

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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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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Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 98

Board Vitals - Pharmacist

DECEMBER 1, 2023

To simplify our EHR and make documentation easier and quicker. I hope to work with different EHRs to find one where surgeons can put the focus back on the patient and allow the surgeon to quickly and completely document the encounter. It’s much easier said than done.”

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Communication Patient Care Documentation Insurance 98

Impact Pharmaceutical Services

AUGUST 17, 2023

The process control strategy doesn’t remain confined to mere documentation, it reaches regulatory recognition. Having a well-developed and well-documented process control strategy provides a comprehensive summary of process understanding. This validation process ensures alignment with the intended performance objectives.

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Documentation 52

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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