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.

Documentation 98

Documentation FDA 98

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.

Hospitals 246

Hospitals Documentation Communication Patient Care 246

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.

Documentation 98

Documentation 98

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

Documentation 98

Documentation FDA 98

IDStewardship

MARCH 12, 2023

Memorizing 45+ page document is certainly not a reasonable expectation, but one can certainly walk away with an awareness of general concepts and themes which are relevant. This blog post I did may also be of interest, on the topic. Daptomycin: from the mountain to the clinic, with essential help from Francis Tally, MD Find it here.

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Medication Guidelines Documentation Labelling Hospitals 299

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In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here ) and whether such plans afford sufficient flexibility for AI/ML developers to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

Documentation 119

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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Documentation Communication 97

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

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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Documentation FDA Adverse Reactions Communication 105

The FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Documentation 64

Documentation FDA 64

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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Documentation FDA Labelling 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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FDA Documentation 105

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.

Medical Records 122

Medical Records Documentation 122

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.

Documentation 98

Documentation 98

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.

Vaccines 68

Vaccines Documentation 68

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

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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Controlled Substances Documentation Dosage Prescription Filling 139

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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Documentation FDA Labelling 98

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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FDA Documentation Labelling Communication 59

The FDA Law Blog

SEPTEMBER 24, 2024

These efforts included the adoption of a new review template for the assessment and documentation to be used in reviewing NDAs and BLAs with an overall goal of having a more collaborative inter-disciplinary approach to the process. Before FDA even asked, we had been considering an HPM FDA Law Blog post on this subject.

Documentation 59

Documentation FDA Packaging 59

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.

Documentation 59

Documentation 59

ISPE

FEBRUARY 13, 2023

Bob also initiated an agreement under which ISPE’s Guidance Documents are made available to PIC/S and WHO inspectors, which is still in place today. Most recently he assisted the regulatory authorities of Saudi Arabia, Russia, China, Jordan, and Philippines in the process to attain PIC/S membership.

Documentation 98

Documentation FDA 98

ISPE

SEPTEMBER 15, 2022

iSpeak Blog. On 24 August 2022, Annex 1 was published by the European Commission after consultations with WHO, PIC/S and FDA Implementation time for this document has been extended to one year for the global document, the clause 8.123 for loading and unloading lyophilizers has a two-year period of implementation.

Documentation 97

Documentation FDA 97

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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FDA Documentation Medical Records 105

pharmaphorum

APRIL 6, 2021

The blog, which covers lifestyle topics and reviews events and products, was even nominated for a National Diversity Award last year. “It It started as a hobby, just a way of documenting my life as a young man with a disability that I could look back on in years to come,” he says.

Documentation 132

Documentation 132

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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Omnicell Medication Dispensing CPhT Documentation 52

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.

Hospitals 98

Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 98

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.

Documentation 52

Documentation Communication 52

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. 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.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Compounding 98

The Pharmacist Blog

MARCH 21, 2015

It can significantly affect how much work I can crank out (Example: only 2 blog posts were made for February and March is not looking so good either). Even in this blog I document my goals and publicize them to hold myself accountable. The post How to Stay Motivated appeared first on The Pharmacist Blog.

Documentation 52

Documentation 52

IDStewardship

MAY 12, 2023

Review your schedule, elective options, and documentation responsibilities We have to start with the basics in order to adequately orient to future expectations. Wishing the best to the new residents and I hope this blog post helps to stimulate some young minds! The jump from PGY2 to clinician is significant.

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Communication Documentation Vaccines 130

pharmaphorum

OCTOBER 27, 2022

Blogs – A company is free to own a blog or engage a blog writer by way of sponsorship or consultancy fees. In the EU and UK, where direct-to-consumer promotion of POMs is prohibited, companies may not sponsor blogs that promote, or could reasonably be expected to promote, such products.

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Communication Packaging Documentation Pharmaceutical Companies 94

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.”

Communication 98

Communication Patient Care Documentation Insurance 98

ISPE

MARCH 3, 2023

Trudy Patterson Fri, 03/03/2023 - 13:15 iSpeak Blog iSpeak ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track! On the contrary, it should enable innovation by ensuring that systems are fit for the intended purpose without creating an excessive documentation burden.

Documentation 98

Documentation FDA 98

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.

Documentation 52

Documentation Communication 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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FDA Documentation Packaging Communication 75

ISPE

JANUARY 10, 2023

iSpeak Blog. This can be found seven times in the entire document. While writing this blog post, I needed a short break, which I used to go to the Assembling Hall and see what Isolator projects are currently being set up and what an unplanned big surprise I met Christa Myers from CRB there. Trudy Patterson. Richard Denk.

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Packaging Documentation 96