ISPE

SEPTEMBER 8, 2023

This article outlines ISPE task teams created reports and a model to examine the challenges surrounding drug shortages, emergency preparedness, and the supply chain of active pharmaceutical ingredients (APIs). and Chair of the ISPE Drug Shortages Team. This article outlines these initiatives.

Documentation 91

Documentation 91

ISPE

MARCH 8, 2023

ISPE Briefs: New Guide Promotes Cultural Excellence Trudy Patterson Wed, 03/08/2023 - 10:07 InTouch March / April 2023 ISPE Briefs: New Guide Promotes Cultural Excellence Marcy Sanford 1 March 2023 Cultural excellence is the expressed and implied ways in which an organization operates.

Documentation 52

Documentation Communication 52

ISPE

NOVEMBER 1, 2022

2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. 2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. Quality and Stability. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”.

FDA 98

FDA Insurance Chemotherapy Documentation 98

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

JUNE 27, 2023

Korakianiti started by referring to the EMA Quality Innovation Group (QIG), which contains EMA assessors and some academics. Rosa also indicated that US FDA has the Emerging Technology Team (ETT,) and he also stressed the need for early engagement since late engagement can lead to problems and delays.

Communication 52

Communication FDA Vaccines 52

ISPE

APRIL 12, 2023

Software that assures the correct amount of validation with input-based decision trees reduces the burden of validation, freeing people to focus on tasks that truly require human attention. Quality teams — Standardized documentation and SOP enforcement mean they can operate more efficiently and have greater confidence in their work.

Documentation 98

Documentation FDA 98

ISPE

NOVEMBER 3, 2022

2022 ISPE Annual Meeting: Convergence and Harmonization Support New Therapies. 2022 ISPE Annual Meeting: Convergence and Harmonization Support New Therapies. Manager, Biotherapeutic Quality Division. Head of Department of Pharmaceutical Assessment. Deputy Director of Science, Office of Pharmaceutical Quality.

Communication 98

Communication FDA Documentation Vaccines 98