OctariusRx

FEBRUARY 20, 2023

The 2023 controlled substance assessment quiz is about to be released! If you read my post in December about How Much Does Compliance Cost , you know that not following proper processes and poor documentation can lead to patient harm and/or large fines from regulatory agencies such as the United States Drug Enforcement Administration (DEA).

Controlled Substances 86

Controlled Substances Documentation Compounding 86

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?

Documentation 52

Documentation Packaging 52

ISPE

MARCH 3, 2023

ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track! 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! 2023 ISPE Biotechnology Conference Frank Henrichmann Heather D.

Documentation 98

Documentation FDA 98

STAT

NOVEMBER 14, 2023

Internal documents show that a UnitedHealth subsidiary called NaviHealth set a target for 2023 to keep rehab stays of patients in Medicare Advantage plans within 1% of the days projected by the algorithm.

Health Insurance Companies 145

Health Insurance Companies Insurance Documentation 145

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510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

Documentation 64

Documentation FDA 64

European Pharmaceutical Review

JULY 4, 2023

The International Organization for Standardization (ISO) has published its new standard Sterilization of health care products — Microbiological methods — Part 3 Bacterial endotoxin testing ( ISO 11737-3:2023). The document contains requirements and guidance for testing for bacterial endotoxins.

Documentation 111

Documentation Labelling 111

The Guardian - Pharmaceutical Industry

OCTOBER 19, 2024

According to internal documents obtained by the Observer , Novo Nordisk wanted “data from the Department for Work and Pensions” to “ help profile those who are most likely to return to the labour market”. Shifting blame to the victims of economic policy is an old trick by politicians.

Documentation 111

Documentation Pharmaceutical Companies Pharmaceutical Companies 111

European Pharmaceutical Review

AUGUST 25, 2023

As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. What is included in the new revision?

Documentation 98

Documentation 98

STAT

OCTOBER 20, 2023

The agency’s data indicate that, after a lull during the Covid-19 pandemic, the number of authorized devices in 2023 is expected to increase by more than 30% over the prior year.

FDA 130

FDA Documentation 130

European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. Implementation of the ICH M10 document The EU date of coming into effect of the core ICH M10 document and the corresponding Q&As was 21 January 2023.

Method Validation 98

Method Validation Documentation FDA 98

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

FDA 98

FDA Documentation Method Validation Packaging 98

STAT

MAY 20, 2024

A huge amount of those documents were released last week, and the numbers mirror what  we’ve been seeing over the past several months : Not all hospitals are in dire straits, and in fact, many continue to do quite well. Sign up to get it in your inbox every Monday. Continue to STAT+ to read the full story…

Hospitals 111

Hospitals Documentation 111

ISPE

MAY 1, 2023

It often took me multiple weeks of Computer Based Training (CBT) and reading documents. I created the templates in my own time and first only used them for my own information, as a reference book, instead of using the regulations to review compliance of CSV documents and controls. Several times I even didn’t pass the exams.

Documentation 98

Documentation 98

European Pharmaceutical Review

JULY 5, 2023

Revised for 2023, the Parenteral Drug Association (PDA) has published an update to its Technical Report No. Having been originally published in 2007, then revised in 2013, this latest 2023 edition addresses evolving standards and container types.

Packaging 96

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 96

European Pharmaceutical Review

MARCH 13, 2024

The data integrity violations API deviations in the microbiology lab The first deviation – failure to follow and document laboratory controls at the time of performance, and failure to document and explain any departures from laboratory procedures – relates to the lack of data integrity within the microbiology laboratory.

FDA 98

FDA Documentation 98

Fuld

NOVEMBER 13, 2023

Practicing War Games at UC Irvine’s business school AI is transforming the private equity deal lifecycle, from document review to data analysis. Each article provides a concise, strategic viewpoint designed to inform and guide your business decisions.

Documentation 52

Documentation 52

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

European Pharmaceutical Review

JULY 18, 2023

In 2023, the deviation management sector is expected to account for the largest share of the pharmaceutical quality management market. Yet the productivity of their R&D investment, compared to the number of drugs introduced to the market each year, is decreasing. Also noted in the report was the shift towards cloud-based systems.

Documentation 98

Documentation Pharmaceutical Companies Pharmaceutical Companies 98

The FDA Law Blog

DECEMBER 4, 2023

11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). Pharmacists and pharmacy management should pay heed to these prescribing red flags, resolve them when they appear and document their resolution. Several weeks later, also based on ability to pay, the U.S. Consent Agreement and Final Judgment ¶ 17.

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

The FDA Law Blog

APRIL 25, 2023

This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Timeline Section 524B became effective on March 29, 2023.

FDA 105

FDA Documentation Labelling Communication 105

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

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. This negates the requirement for storage of paper evidence and correct GMP document management of these hardcopy evidences.

Documentation 98

Documentation FDA 98

IDStewardship

MARCH 12, 2023

BCPS, BCIDP Article Posted 12 March 2023 As a pharmacist serving as a preceptor to students and residents in the area of infectious diseases since 2010, I have always been on the hunt for good infectious diseases journal articles for my learners to read. Authored by: Timothy P. Gauthier, Pharm.D.,

Medication Guidelines 299

Medication Guidelines Documentation Labelling Hospitals 299

The FDA Law Blog

JULY 6, 2023

We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here ). This would align with the timeline in the Unified Agenda which identifies December 2023 as the expected publication date for the final rule.

FDA 52

FDA Documentation Labelling 52

PQA

MARCH 12, 2025

In 2023, PQA launched a multiphase national MTM initiative to address stakeholder needs and advance MTM quality measurement. 1-2 years) Increase standardized HIT for documentation of MTM services Re-establish consensus on standards for clinical documentation for MTM services (e.g.,

Documentation 40

Documentation Patient Care 40

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.

Documentation 98

Documentation 98

Board Vitals - Pharmacist

NOVEMBER 30, 2023

This magical pen can scan 3,000 characters of text per minute and digitize them into a document for future reference and study. The post BoardVitals 2023 Gift Guide: Best Gifts for Nurses and Doctors appeared first on BoardVitals Blog. Mini Anatomical Learning Set Anatomy and Physiology are at the core of every medical education.

Hospitals 59

Hospitals Documentation 59

European Pharmaceutical Review

DECEMBER 19, 2023

The document was adopted by EMA’s Management Board at its December meeting. Work has already begun with the ongoing public consultation on the AI reflection paper, open until the end of 2023. The plan was prepared by the Big Data Steering Group (BDSG), a joint initiative between HMA and EMA.

Packaging 105

Packaging Documentation 105

The FDA Law Blog

MARCH 27, 2023

The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA. So, what is special about September 24, 2023? For the stakeholders who use UPC as their device identifier, UDI alternatives UDI-A160001 and UDI-A16002 will expire on September 24, 2023.

Packaging 45

Packaging Labelling FDA Documentation 45

Pharmaceutical Technology

APRIL 13, 2023

Projections for 2023 Digitalisation is key moving forward Fully utilising digitalisation as part of a DCT can result in savings in both time and costs. In the US, the FDA (Food and Drug Administration) granted accelerated approvals of medical devices with AI in 2022 [8] , and growing use is expected throughout 2023.

Documentation 52

Documentation Communication FDA 52

European Pharmaceutical Review

SEPTEMBER 13, 2023

Simplify administrative procedures and reporting requirements for SMEs by launching the Once-Only Technical System (part of the Single Digital Gateway ) by the end of 2023. This will allow these firms to complete administrative procedures across the Single Market without needing to re-submit documents. This is compared to 1.8

Communication 96

Communication Documentation 96

European Pharmaceutical Review

FEBRUARY 1, 2023

From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). With CTIS, sponsors can now apply for authorisations in up to 30 EU/EEA countries at the same time and with the same documentation.

Documentation 104

Documentation 104

Pharmaceutical Technology

MAY 17, 2023

No, you can upload your case studies as a Word or PDF document using the upload feature in the online form or email it How will our case studies be used? Case study information may be published alongside your award.

Packaging 52

Packaging Documentation 52

PQA

FEBRUARY 23, 2023

In 2023, PQA’s COPD Treatment Ratio (CTR) TEP will conclude following its launch in 2022. PQA will launch two additional TEPs in 2023. Self-nominations for these TEPs will be communicated to PQA members in the second or third quarter of 2023, and we encourage interested PQA members to submit a self-nomination for consideration.

Specialty Pharmacies 40

Specialty Pharmacies Documentation Communication 40

European Pharmaceutical Review

JANUARY 2, 2024

While advantages to the Quality by Design approach is clear and practical implementation of Quality by Design is encouraged by publication of public guidance documents ICH Q8(R2) – ICH Q14, the industry has not yet fully embraced the QbD approach in Marketing Authorisation Applications (MAAs) for European market approval, the authors noted.

Documentation 105

Documentation 105

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

European Pharmaceutical Review

MARCH 19, 2024

million in 2023, the report predicted it will witness a CAGR of 19.72 According to research by InsightAce Analytic Pvt. the global continuous bioprocessing market is expected to value $1,067.8 million by 2031. While the market was valued at $255.9 percent between 2024-2031.

Documentation 94

Documentation 94