pharmaphorum

JANUARY 18, 2022

Main Conference: April 25 – 26, 2022 | Workshops: April 27, 2022. Primary Packaging material designers. Secondary packagers. POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Workshop Leader: Theresa Jeary, Technical Specialist & Scheme Manager, BSi. SMi’s 9th Annual Conference.

Packaging 52

Packaging FDA Documentation Vaccines 52

ISPE

JANUARY 10, 2023

This can be found seven times in the entire document. aseptic processing line, filling zone, stopper bowl, open primary packaging or for making aseptic connections under the protection of first air).". Plenty of time for discussion, networking, and interactive workshops in smaller groups.

Packaging 96

Packaging Documentation 96

PQA

JUNE 27, 2024

These concepts were then further evaluated during a workshop with specialty pharmacy stakeholders, during which turnaround time emerged as a high priority for measure development. Pilot participants were provided a technical package containing all resources needed to accurately calculate the SP-TAT-PH measure.

Specialty Pharmacies 40

Specialty Pharmacies Communication Packaging Documentation 40

ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

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 how do we package that up?” But we need to evaluate for the gains we hope for, as well as for any unintended consequences.”. A practical consensus.

Documentation 52

Documentation Packaging Communication 52

The FDA Law Blog

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development. CBER will not commit to reviewing packages greater than 250 pages.

FDA 59

FDA Documentation Packaging 59