ISPE

FEBRUARY 14, 2023

This blogpost will summarize inspection topics for presenting digital CQV content and provide a list of common questions encountered during inspection events. Presenting this digital CQV content in inspection events requires a different set of presentation strategies than those needed for paper systems.

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Documentation Packaging 52

ISPE

AUGUST 30, 2023

™ Steering Committee is proud to present Holistic Digital Pharma 4.0 Various case studies will be presented around formality, subjectivity, decision-making, and product availability. to help facilitate participants in developing a CCS using a case study and supporting documentation from an existing cGMP facility. The Pharma 4.0™

Documentation 98

Documentation Vaccines 98

ISPE

MARCH 3, 2023

Watson Elena Vulpe 3 March 2023 GAMP ® 5 (Second Edition) was published on 29th July 2022 and was presented and discussed at the 2023 ISPE Annual Meeting and at several local GAMP ® events held around the globe. Frank Henrichmann Heather D. Computer System Validation should not be a hindrance to innovation.

Documentation 98

Documentation FDA 98

Hospital Pharmacy Europe

MARCH 6, 2023

Given the value of essential oils for perennial allergic rhinitis, in the current study presented at AAAAI, the role of an essential oil nasal spray, which contained menthol, eucalyptol, thymol, camphor, birch oil, pine oil, cinnamon and mint, was evaluated over a period of 7 days by patients with seasonal allergic rhinitis.

Documentation 98

Documentation Hospitals 98

ISPE

NOVEMBER 23, 2022

The Symposium program comprised a wide range of presentations and panel discussions on GMP-related topics, which included participation from Heads of Medicines Agencies, Heads of GMP Inspectorates, official PIC/S representatives and ISPE. He indicated that PIC/S participates in the ICH Q12 implementation Working Group.

Documentation 98

Documentation FDA Communication 98

IDStewardship

OCTOBER 28, 2022

Develop a manual or guidance document outlining the goals of the account. This type of document is especially helpful for account management transitions in resident managed accounts. Multiple pharmacy organizations have guidance or best practice documents pertaining to social media use. Presentation to your peers?

Documentation 229

Documentation 229

European Pharmaceutical Review

SEPTEMBER 2, 2022

The call for transparency in the presentation of study sampling methodology should not be limited to RMM effectiveness studies. The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. Any additional comments?

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Adverse Reactions Documentation Medical Schools Packaging 78

ISPE

FEBRUARY 14, 2023

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Know the key topics.

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Documentation Communication 52

IDStewardship

AUGUST 17, 2022

I like when presentations and documents are sent in advance, but that is not always feasible. Another way to avoid surprises is to ensure key stakeholders have been given the chance to provide guidance and opinions on voting items ahead of time, so those can be considered in how the item will be presented and steered.

Documentation 130

Documentation 130

Hospital Pharmacy Europe

FEBRUARY 1, 2024

‘As there have been significant changes, it is strongly recommended that all definitions are read and understood to assist in the interpretation of the standards themselves and the document should be read in full,’ the Standards’ introduction says.

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Documentation Hospitals Patient Care 52

ISPE

SEPTEMBER 14, 2023

Wager 14 September 2023 With a recent increase in interest and participation, the ISPE GAMP® Special Interest Group (SIG) focusing on Manufacturing Execution Systems (MES) has mapped out an ambitious number of subject areas to use as the basis for future publications, presentations, and best practice guidance documents.

Documentation 98

Documentation 98

pharmaphorum

SEPTEMBER 28, 2022

A new final guidance document that dropped today updates a 2019 draft guidance and clarifies the categories of clinical decision support software that would not be regulated by FDA as a medical device. “I O’Leary said.

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FDA Documentation 134

pharmaphorum

OCTOBER 12, 2022

Presentation of data is vital when regulators carry out formal inspections. Facilities can be asked to provide documented records of environmental monitoring, as well as personnel interaction with systems of record and the order in which events occurred.

Documentation 101

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 101

European Pharmaceutical Review

JANUARY 17, 2023

The document was commissioned by the Advanced Therapy Treatment Centres network’s Industry Advisory Group. Catapult presents vision for UK’s cell and gene therapy future. In March 2022, the CGT Catapult published the ‘National Cell and Gene Therapy Vision for the UK’.

Documentation 105

Documentation 105

ISPE

MARCH 30, 2023

To this end, ISPE has collaborated with Biophorum to present their Digital Technology Roadmap, which builds upon the Digital Plant Maturity Model, to set out challenges and identify the key enablers for organisations to unlock the potential of digitalization. Greenfield facilities that have been the first to embrace the tools of Pharma 4.0

Documentation 98

Documentation 98

pharmaphorum

MARCH 16, 2021

In a review of the documents, the BMJ said they showed concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production. According to the BMJ EMA scientists ensuring the manufacturing quality of the product found “truncated and modified mRNA species present in the finished product”.

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Vaccines Documentation 136

The FDA Law Blog

JUNE 27, 2023

FDA also requests a “detailed description of the allegation with any available supporting documentation.” In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission.

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FDA Documentation Labelling Communication 59

pharmaphorum

NOVEMBER 15, 2021

That’s why the GLSP document, which has been included in EudraLex Volume 10, is just as applicable in other markets, including the UK and US, as they are in the EU. “We The text, the structure of the text, and the presentation of data needs to account for a limited understanding.”.

Documentation 98

Documentation Communication Hospitals 98

ISPE

NOVEMBER 23, 2022

Presentations included Right Sizing and Simplifying Quality Compliance to Enable Company Success; Building Quality and Managing Risk in Unprecedented Times: A Story About Quality Culture from the Front Line; and Building-in Quality and Compliance from the Beginning. A presentation on ISPE’s Pharma 4.0®

FDA 52

FDA Documentation 52

The FDA Law Blog

FEBRUARY 7, 2024

In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. Thus, such persons are subject to identification, recordkeeping, and reporting requirements. Also, a DEA Form 452 report must be electronically filed within 15 days after the order is shipped.

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Controlled Substances Documentation 116

The FDA Law Blog

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. By Larry K. to be codified at 21 C.F.R. to be codified at 21 C.F.R.

Controlled Substances 52

Controlled Substances Documentation Communication 52

pharmaphorum

DECEMBER 30, 2022

The report also finds that the joint briefing document presented to the advisory committee did not adequately represent differing views within the FDA on Aduhelm. Moreover, additional informal meetings, telephone calls and emails were undocumented – contravening FDA’s internal recording policies.

FDA 57

FDA Documentation Labelling 57

Hospital Pharmacy Europe

AUGUST 17, 2023

11 Many documents and checklists detail every stage of the pathway in preparing CAR T. 12 The document aims to harmonise the implementation of hospital pharmacy CAR T services. 12 The document aims to harmonise the implementation of hospital pharmacy CAR T services.

Hospitals 98

Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

pharmaphorum

SEPTEMBER 29, 2022

The FDA has issued multiple guidance documents over the past several years in an attempt to illustrate what is and what is not a medical device, what is subject to enforcement discretion, and what the FDA actively regulates. More information about this process may be found in FDA’s 513(g) Guidance Document. not a medical device, ii.

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FDA Documentation 100

The FDA Law Blog

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. 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. When referencing documents within the AI response, cite location within the 510(k) supplement (e.g.,

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FDA Documentation Packaging Communication 75

ISPE

SEPTEMBER 21, 2023

This track will delve into five important topics where you will hear from speakers who will help answer your questions and provide you with the necessary information to make confident decisions regarding any updated changes to your facility, equipment, procedures, and documents.

Documentation 98

Documentation FDA 98

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. His outstanding presentation provided important insights regarding learning, and how knowledge is acquired and applied. Try to understand what you do not know.

Documentation 98

Documentation 98

PQA

DECEMBER 1, 2023

In support of this goal, PQA has performed a review of its bylaws and proposes revisions which modernize and streamline this important governing document. Our Board of Directors unanimously approved in September the revisions recommended by the Board’s ad hoc Bylaws & Policy Committee.

Community Pharmacies 59

Community Pharmacies Documentation Communication 59

The Checkup by Singlecare

FEBRUARY 15, 2024

However, simply having a qualifying disability typically isn’t sufficient; the person also needs documentation from a medical professional that indicates that the service animal could improve or support his or her condition. To be eligible for a service dog , individuals must meet the ADA criteria for a mental or physical disability.

Health and Personal Care Stores 98

Health and Personal Care Stores Documentation Grocery Stores Hospitals 98

European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

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Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 88

PQA

MARCH 3, 2023

The second edition of the guide documents real-world SDOH services that are promising for improving the quality and safety of medication use. The appendix documents a host of characteristics and subcategories for the initiatives to aid in ease of identification.

Vaccines 52

Vaccines Documentation Community Pharmacies 52

The FDA Law Blog

DECEMBER 12, 2022

It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient. The introductory paragraph states: The review and understanding of this document is a critical step in making the decision whether you should choose LASIK surgery. After reviewing the information. Draft LASIK Guidance at 22.].

Labelling 52

Labelling FDA Documentation 52

PQA

SEPTEMBER 1, 2022

You can listen to the full recording of this Quality Forum Webinar, a one-hour presentation with audience Q&A, on PQA’s YouTube channel. PQA members can access the presentation slides in the Member Resources Library.

Documentation 52

Documentation 52

pharmaphorum

NOVEMBER 25, 2022

Spectrum filed for accelerated approval of poziotinib as a second-line treatment for patients with HER2 exon 20 insertion-mutated, non-small cell lung cancer (NSCLC), but the FDA was unconvinced by the phase 2 data presented in support of the drug.

FDA 98

FDA Documentation 98

pharmaphorum

DECEMBER 19, 2022

Colombo’s presentation was followed by the panel, ‘The future of European cancer control in a time of crisis’. There were communication and psychology problems, he explained, and documentation was scarce or missing. Fitzgerald believed the present moment is unique, demanding international collaboration.

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Documentation Hospitals Communication Vaccines 92

Roots Analysis

AUGUST 9, 2023

In addition, among It is worth mentioning that Europe presently has the maximum share in the growth of manufacturing execution system providers in healthcare market.

Documentation 52

Documentation Communication 52

ISPE

DECEMBER 6, 2022

Value of getting more information and context outweighs the risk of potentially having a documented path without conclusion. The same holds for whether we are paper based or digital; we should understand that documentation, in any form, should be kept professional and on-topic. Can’t perfect what we present.

Documentation 52

Documentation Communication 52