Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 2019. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
The GAMP® Global Leadership strongly supports a patient-centric and quality risk-based approach to the assurance of computerized systems. Explore the incorporation of innovative computerized technologies and approaches that advance pharmaceutical production to support product quality, patient safety, and data integrity.
See the ICH Q12 regulatory guideline, featuring detailed instruction for the break-down of complex regulation and other challenges facing the pharmaceutical industry. Professionals can adjust current production and develop new operations for excellence with the support of these management strategies.
Discover the most common violations to avoid for the implementation of a cleaning validation program in today’s industry with product-specific operations, sterile manufacturing, and how to organize pre-approved strategies. In addition, solutions to these common pitfalls are featured in this article.
Kerren Bergman, Vice President US Operations and Global HR for Hyde Engineering, discusses a crucial reminder for women to stop apologizing and be more confident in their opinions. She examines how to build your personal power, and fully understand the impact of your words in professional settings. Learn how to strengthen your voice and communicate your valuable opinions!
Read highlights from the 2019 ISPE Annual Meeting and Expo where the 2020-2022 Strategic Plan was introduced, and Frances Zipp was honored as the New chair for the ISPE International Board of Directors. See details for each award presented and the influential leaders in today’s pharmaceutical industry, who are included in the growing ISPE network.
Since starting with ISPE, Edyna Miguez, has had the incredible opportunity to connect with women across the globe working within the pharmaceutical industry, as part of the ISPE Women in Pharma® program. The tenure of these rising female leaders varies, as do their cultural backgrounds. However, one fact remains consistent: they are looking to make the industry a more equitable and...
The ISPE GAMP® 5 Guide (Second Edition) was published on 29 July 2022. It was presented and discussed at the 2023 ISPE Europe Annual Conference, the 2023 ISPE Annual Meeting & Expo, and at several local...
The importance of the 2024 ISPE Europe Annual Conference is evident with the continuous challenges the pharmaceutical industry is facing in terms of drug shortages, regulatory requirements, digitalization, automation, and big data management.