Read, Learn, Innovate: Top Blog Posts from July 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from July 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Agile Software Development in GxP Regulated Environments Special Interest Group
There is sometimes a perception that computer systems validation requires a V-Model approach using a waterfall methodology. This means all requirements must be agreed before design can progress and in turn all design must be signed off before the system can be built, and so on until system release into operation.
Best Practices for Maintaining Pharma Supply Chain Continuity in a Complex & Dynamic Environment
Although travel continues to be reduced or restricted across the world, there is an upside: The 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum has now pivoted into a fully virtual conference and virtual executive forum providing attendees located anywhere in the world with real-time engagement with Regulatory and Industry leaders.
Women’s Initiative – Pharma Ladies in Russia
Our story started in October 2018 when I met a colleague at a conference and we had no time even to share our news: we were always in a hurry, only able to discuss business. The pharmaceutical industry is unique in its stability: many people who come here stay for a long time, and eventually colleagues become close friends. This is what happened to me: close professional engagement enabled me to develop relationships with amazing people, especially women.
Supporting Pharma Innovation Through Analytics
Ensuring delivery of effective medicines requires an agile business strategy effectively utilizing technology to:
- shorten process development times from lab to commercial launch,
- establish streamlined facilities with emphasis on sustainability and flexibility,
- achieve robust quality through utilization of control and predictive capabilities,
Q&A: Commissioning and Qualification - Quality Unit and System Risk Assessment
Making clinical trials more patient centric is among the many challenges facing the pharmaceutical industry. One method of improving the patient experience is by delivering study medication directly to patient homes, also known as Direct-to-Patient or DtP. However, the implementation of Direct-to-Patient may seem insurmountable in a highly regulated industry where specific regulations or guidance is lacking or vague.
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