iSpeak Blog

Reading Roundup: Top Blog Posts from April 2016
Laptop with Morning Coffee

It’s time for another edition of the Reading Roundup featuring the top blog posts from April 2016.  Grab your favorite cup of coffee, kick back and catch-up on what the pharmaceutical industry was reading in April.

OSD Gowning Procedures Knowledge Brief

Learn everything you need to know about the proper Oral Solid Dosage (OSD) Gowning procedures including the different levels, requirements, and risk assessment considerations for your facility.

Considerations for a Corporate Data Integrity Program

This blog post was a top post in March and is topping the charts again in April - and with the great information and interest in joining the Data Integrity Special Interest Group (SIG), we couldn't pass up giving this a spot in the reading roundup again.

Data integrity has become one of the hottest regulatory and compliance topics impacting the pharmaceutical industry in years.  To help understand the critical success factors for a corporate data integrity program, the ISPE GAMP® COP released a Concept Paper entitled “Considerations for a Corporate Data Integrity Program”.  Learn more about the data integrity concept paper and download it today!

Process Validation Lifecycle Implementation for Existing Products

Where are you at with implementing the NEW process validation lifecycle?  What about the verification of existing, or "legacy", products?  Download the Process Validation Lifecycle Implementation for Existing (“Legacy”) Products discussion paper by the ISPE Process Validation (PV) Team which answers all the questions you have about what you should be thinking about and implementing the process validation lifecycle.

Can Your Data Integrity Process Stand up to Regulatory Scrutiny?

Gain tools and techniques to implement proper controls for data to ensure the integrity and validity of information throughout the data lifecycle in the NEW data integrity process course.

Plant-Made Pharmaceuticals Bring Speed & Flexibility for Protein Expression

In this blog series, learn about the basics of plant-made pharmaceuticals and how they can help scientists in pre-clinicals or early stage clinicals quickly go from "gene to protein" in a few weeks.

Design Considerations for WFI Distillation Systems Part 1

This three-part series presents and discusses a number of key requirements and design, quality, and engineering considerations that have high importance in end-user usability, cost control, and end-product quality that help manage risks in Water for Injection production and processes.  Part one reviews design considerations from the perspective of different distillation methods and systems with WFI product against back pressure.