iSpeak Blog

Read, Learn, Innovate: Top Blog Posts from June 2019

ISPE
Read, Learn, Innovate: Top Blog Posts from June 2019 - ISPE Pharmaceutical Engineering

Featured in this edition of ISpeak iSpeak Reading Roundup are the top blog posts from June 2019. Explore critical- industry initiatives, membership Membership highlights, and more for what the pharmaceutical industry was reading last month.


The Evolution of Process Validation: From Box-Checking to Lifecycle Approach to Biologics Continuous Manufacturing

The Evolution of Process Validation: From Box-Checking to Lifecycle Approach to Biologics Continuous Manufacturing

The incorporation of statistical evaluations and scientific approaches supports the biopharma world in developing successful process validation techniques. The world of biopharmaceuticals is advancing along with the process knowledge and understanding of manufacturers. Learn more about these cutting-edge developments and biopharma innovation.

Read More


Continued Process Verification, 3rd Stage of FDA Process Validation Guidelines

Continued Process Verification, 3rd Stage of FDA Process Validation Guidelines

GMP bioprocessing includes crucial attributes that must actively be monitored and controlled during observation and process validation. The Continued Process verification plan aims to eliminate risks in production and to increase regulatory approval. See the primary points that influence bioprocess and new parameters on the market.

Read More


Member Spotlight: Buket Hekiman Bayraktar

Member Spotlight: Buket Hekiman Bayraktar

Buket has been involved with ISPE since her time in college at Istanbul University. While pursuing her skills and interest in pharmaceuticals, she stayed connected to ISPE through the Turkey Affiliate’s efforts to increase pharmaceutical knowledge and opportunity. Find out how ISPE membership can further both career and personal development.

Read More


Design Considerations for WFI Distillation Systems Part 1

Design Considerations for WFI Distillation Systems Part 1

“WFI production is a critical part of any parenteral drug process. There are several factors that need to be considered when selecting WFI production methods, such as capacity, future needs, storage, and quality control.” Discover water for injection innovations with this technology overview.

Read More


Direct to Patient: Quality Considerations & Novartis Experience

Direct to Patient: Quality Considerations & Novartis Experience

The objective for this introductory blog is for members of the pharmaceutical community to share their direct to patient quality experiences, learnings, and questions while ensuring that concerns and recommendations are met. Explore the models that will improve the patient experience.

Read More