ISPE

MARCH 3, 2023

On the contrary, it should enable innovation by ensuring that systems are fit for the intended purpose without creating an excessive documentation burden. Computer System Validation should not be a hindrance to innovation. Link them through a TM, otherwise the FDA will give you a 483!”

Documentation 98

Documentation FDA 98

Board Vitals - Pharmacist

APRIL 22, 2022

Events sponsored by an accredited CME provider include national, regional, or local conferences, workshops, seminars, journal clubs, simulation labs, and live webinars. While this is a good idea, in theory, keep in mind that your time may be limited due to your obligation to attend lectures and workshops. Live CME Conferences .

Documentation 52

Documentation 52

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.

FDA 52

FDA Documentation 52

ISPE

JULY 14, 2023

Ideally, a playback session should be conducted, covering the understanding of core manufacturing business process flows, systems used, pain points, and key persona views after the workshop with business representatives from each function.

Documentation 98

Documentation 98

ISPE

JANUARY 10, 2023

This can be found seven times in the entire document. Plenty of time for discussion, networking, and interactive workshops in smaller groups. For PSM, robotized aseptic filling means more than automated processes, so important requirements from the new EU GMP Annex 1 are considered, such as First Air.

Packaging 96

Packaging Documentation 96

pharmaphorum

AUGUST 30, 2022

The importance of patient and public involvement and engagement (PPIE) has been well documented, but there has, to date, been a lack of practical advice on how to implement and manage meaningful processes. . Moving the conversation . This is not something that has been developed in isolation,” said Stubbs. “I

Communication 83

Communication Documentation 83

pharmaphorum

FEBRUARY 2, 2022

Through a series of workshops and surveys, which collected the views of research professionals, patients and carers, the group has developed a new guidance document. But we need to evaluate for the gains we hope for, as well as for any unintended consequences.”. A practical consensus. Everything has moved so quickly.

Documentation 52

Documentation Packaging Communication 52

pharmaphorum

FEBRUARY 25, 2021

Published in January, the document replaces 2013’s UK Strategy for Rare Diseases and sets out four priorities for the next five years: faster diagnosis, increasing awareness among healthcare professionals, the better coordination of care, and improving access to specialist care, treatments, and drugs.

Documentation 111

Documentation Labelling 111

Impact Pharmaceutical Services

SEPTEMBER 20, 2023

Results Syner-G reviewed a wide spectrum of documents to ensure compliance with respect to GMP requirements. The review of the documents included master and executed batch manufacturing records, batch related deviations, investigations, analytical data, validation reports and protocols. Significant improvement was observed.

Documentation 40

Documentation 40

ISPE

NOVEMBER 1, 2022

International convergence is another area in which the FDA is a participant, including in initiatives related to viral safety (ICH Q5A), CM (ICH Q13), quality risk management (QRM; ICH Q9), analytical procedure development (APD; ICH Q2/14), pharmaceutical product life-cycle management (ICH Q12), and common technical document (ICH M4Q).

FDA 98

FDA Insurance Chemotherapy Documentation 98

The FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA).

FDA 59

FDA Documentation Labelling 59

ISPE

OCTOBER 27, 2022

In addition to the topical tracks, there will also be workshop-type discussion groups where you can directly interact with your fellow participants and ask your questions in an open forum. In real-life case studies, they will share their learnings with solutions that you can apply to your challenges immediately.

Dosage 98

Dosage Vaccines FDA Documentation 98

ISPE

JULY 19, 2023

™ started in 2015 at the ISPE Germany/Austria/Switzerland (D/A/CH) “Plug and Produce” workshop in Basel, Switzerland. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance? Christian Wölbeling, Körber Pharma, Germany, gave an overview addressing where we are with Pharma 4.0.

Documentation 98

Documentation FDA Labelling Communication 98

ISPE

JULY 5, 2023

CDER funded the National Academies of Sciences, Engineering, and Medicine (NASEM) to host a series of workshops that resulted in a consensus study report “Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, Recommendations.” FDA/M-CERSI Co-Processed API Workshop Proceedings.”

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

OCTOBER 27, 2022

Covered by Medical Device Regulations according to decision tree per Medical Device Coordination Group (MDCG) Guidance 2019-11: Covered by Medical Device Regulations according to decision tree per MDCG document 2019-11: 1. 2021 Workshop Report–Digital Technologies for Clinical Evidence Generation.” Published May 2006. 33 HealthXL.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

Covered by Medical Device Regulations according to decision tree per Medical Device Coordination Group (MDCG) Guidance 2019-11: Covered by Medical Device Regulations according to decision tree per MDCG document 2019-11: 1. 2021 Workshop Report–Digital Technologies for Clinical Evidence Generation.” Published May 2006. 33 HealthXL.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

ISPE

SEPTEMBER 11, 2023

Summary from Advanced Manufacturing Technology Workshop Held at 6th Accelerating Biopharmaceutical Development Meeting.” Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. Advanced Manufacturing.” 7 June 2023.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

SEPTEMBER 8, 2023

A final report will be provided as the basis for an ISPE workshop, with recommendations subsequently published in Pharmaceutical Engineering and other trade publications. en/documents/other/european-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf 11 European Medicines Agency. 22 June 2023.

FDA 52

FDA Dosage Documentation Communication 52