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

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 ). Any comments to the public notice must be submitted by August 11, 2023.

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FDA Documentation Labelling Communication 59

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

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.

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FDA Documentation Labelling Communication 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

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

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. Offer helpful solutions.

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Documentation Communication 52

The FDA Law Blog

AUGUST 7, 2023

Submit proposal documents by email to ELP Proposal Submissions by September 5, 2023 at 12 PM ET. Identify the site visit duration. Most common are one- or two-day site visits.) Indicate ability to host a virtual site visit.

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Documentation Insurance FDA 40

The FDA Law Blog

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. CDER and CBER CDER and CBER announced they would resume in-person face-to-face (FTF) industry meetings on February 13, 2023. The pandemic had changed the way people live, work and communicate.

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FDA Communication Documentation 53

The FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests. By Philip Won & Allyson B.

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FDA Documentation Labelling 52

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

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.

Documentation 52

Documentation Communication 52

ISPE

JANUARY 10, 2023

Tue, 01/10/2023 - 12:15. iSpeak Blog. 10 January 2023. The Robotic Session during the 2023 ISPE Aseptic Conference in Bethesda, MA on 6-7 March has been established for several years. This can be found seven times in the entire document. 2023 ISPE Aseptic Conference. Trudy Patterson. Richard Denk.

Packaging 96

Packaging Documentation 96

IDStewardship

APRIL 13, 2023

BCPS, BCIDP Article Posted 14 April 2023 In 2014 CDC released the Core Elements of Hospital Antibiotic Stewardship Programs (Core Elements) to help hospitals increase infection cure rates while reducing treatment failures, C. The latest antimicrobial stewardship regulations from The Joint Commission went into effect in January 2023.

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Hospitals Documentation Communication Patient Care 236

ISPE

SEPTEMBER 8, 2023

2023 ISPE DRUG SHORTAGES PREVENTION MODEL The 2023 ISPE Drug Shortages Prevention Model serves as a guide to help prevent drug shortages by providing quality, regulatory, and technical recommendations for the pharmaceutical manufacturing industry. This article outlines these initiatives. What do you love about your job?

Documentation 91

Documentation 91

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

SEPTEMBER 21, 2023

Join the First Discussion after the 25 August Effective Date Trudy Patterson Thu, 09/21/2023 - 08:38 iSpeak Blog iSpeak Annex 1 in Force! Gorton 21 September 2023 PIC/s Annex 1, and the WHO Annex 2 for the manufacturing of sterile products took effect on 25 August 2023, and the time to attend the 2023 ISPE Pharma 4.0™

Documentation 98

Documentation FDA 98

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

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted.

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Documentation FDA 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. During the 2023 ISPE Europe Annual Conference , you will have the opportunity to explore all these topics in details.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Dosage 98

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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FDA Documentation Communication 59

ISPE

AUGUST 15, 2023

™ and Annex 1 Conference on 11-12 December 2023. ™ and Annex 1 Conference on 11-12 December 2023. How can hardware, software, and process understanding be combined to create good GMP validation documents? Join us at the 2023 ISPE Pharma 4.0™ ™: How do they fit together?” A good way to build in quality by design!

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Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

NOVEMBER 23, 2022

iSpeak Blog. Some of the highlights of the presentations given during the Symposium were as follows: The PIC/S Chairperson, Paul Gustafson, Health Canada, presented on PIC/S’ new strategic plan for 2023-2027 which covered the following elements: Promote, improve and monitor inspection reliance amongst PIC/S member authorities.

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Documentation FDA Communication 98

ISPE

MARCH 30, 2023

The digital transformation track of the 2023 ISPE Biotechnology Conference aims to explore all aspects of this journey, providing case studies and tools for attendees to feel confident in taking the next step down the road of digitalisation, no matter where their starting point may be. View Programme 2023 ISPE Biotechnology Conference

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Documentation 98

ISPE

JULY 14, 2023

This blog presents our point of view, covering the strengths and weaknesses of the SIRI framework, and suggests a potential way forward to complement its outcomes. journey in Pharma, Biopharma, and Medical Devices manufacturing plants. journey in Pharma, Biopharma, and Medical Devices manufacturing plants.

Documentation 98

Documentation 98

The FDA Law Blog

JUNE 21, 2023

As acknowledged in the Strategic Priorities document, certain demographic groups may have limited access to necessary treatments and diagnostics. We previously blogged on the draft guidance here. For those who are interested, comments should be submitted to the docket ( FDA-2023-N-1956 ) by August 30, 2023.

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Documentation FDA Patient Care Hospitals 45

IDStewardship

MAY 12, 2023

BCPS, BCIDP Article posted: 12 May 2023 The ASHP pharmacy residency match phases 1 and 2 have come to a close. Review your schedule, elective options, and documentation responsibilities We have to start with the basics in order to adequately orient to future expectations. Authored by: Timothy P. Gauthier, Pharm.D.,

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Communication Documentation Vaccines 130

ISPE

MARCH 20, 2023

In context of this blog, an interface is connecting two or more systems, including transport technology and middleware where necessary. Checklist 1 offers detailed guidance by allocating and documenting the responsibilities in the affected processes and overall system context.

Documentation 97

Documentation Communication 97

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

The FDA Law Blog

AUGUST 9, 2023

48365, 48369 (July 27, 2023). As with other required controlled substance records, electronic records documenting EPCS transfers must be maintained for two years from the transfer date by both the transferring and receiving pharmacies. to be codified at 21 C.F.R. to be codified at 21 C.F.R.

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Controlled Substances Documentation Communication 52

The FDA Law Blog

JUNE 19, 2023

Over the years we have blogged many times on the twists and turns of the efforts to regulate LDTs. Given the make-up of the House and the aversion to expansion of FDA authority, it seems extremely unlikely that the newest version of the VALID Act, which was introduced in March 2023, will advance in the next two years.

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FDA Documentation 56

PQA

JULY 28, 2023

Learn more in Micah Cost's new blog. Your Next Engagement Opportunities Network, Learn and Collaborate with PQA PQA's 3rd Quarter 2023 Stakeholder Advisory Meeting is August 16, 1-1:30 pm ET. data availability), and usability; and Other strategies to advance and assess quality of MTM services.

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Documentation Vaccines 40

ISPE

JULY 21, 2023

ICH Q9 (R1): The Next Frontier Trudy Patterson Fri, 07/21/2023 - 11:53 iSpeak Blog iSpeak ICH Q9 (R1): The Next Frontier Christopher John Potter, PhD 21 July 2023 A one-day seminar titled ICH Q9(R1): The Next Frontier was hosted by the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (TU Dublin) on 1 June 2023.

Documentation 98

Documentation 98

ISPE

JULY 24, 2023

Backup and Disaster Recovery To ensure continued data availability, the CSP should have a fully documented backup and disaster recovery plan that outlines backup frequency, primary and backup server locations, automated recovery methods, security measures for backups, and recovery time objectives.

Communication 98

Communication Documentation 98

ISPE

MARCH 29, 2023

The Culture Club: Wrapping it up - Part 4 of 4 Trudy Patterson Wed, 03/29/2023 - 10:55 iSpeak Blog iSpeak The Culture Club: Wrapping it up - Part 4 of 4 Michelle Vuolo Levi Schenk Andre L. The Culture Club, this blog. Also, writing this blog! Walker, CPIP Brandi M. In my experience this is not always the case.

Documentation 96

Documentation 96

The FDA Law Blog

MAY 22, 2023

The California Department of Food and Agriculture (CDFA) issued regulations implementing Proposition 12 on September 1, 2022, but their implementation was enjoined until July 1, 2023, pending the Supreme Court’s decision. California is not the only state to have established animal welfare requirements affected by the Supreme Court’s decision.

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Documentation 45

The FDA Law Blog

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.

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FDA Documentation Communication 45