I received a Bachelor of Science in Electrical Engineering from Tuskegee University and a Master’s Certificate from Purdue University in Regulatory and Quality Compliance.
When I graduated college, I had no prior knowledge of the industry. I wanted to get a better understanding of the pharma world and what better way than to join a professional interest group.
I joined ISPE in 1993. My initial exposure was on the equipment and instrumentation side seeking to understand how equipment works and to get a better understanding of equipment/devices from the vendor perspective. Commissioning and Qualification (C&Q) was my primary interest. Based on a shift in work responsibilities in 2007, I was asked to be liaison between the GAMP® Communities of Practice (CoP) and the Commissioning and Qualification Communities of Practice. Becoming a part of the GAMP® community was a great next step for me.
I work in quality systems where I assess current requirements for marketing authorization (MA). My work responsibilities include: oversight for data integrity/data security issues, system lifecycle, change management, system training, and audit support.
Currently I am an active member of the GAMP® Americas Steering Committee. I’m part of a sub-committee that is planning the 2017 Data Integrity GAMP® Forum scheduled for 15 June 2017, in Indianapolis, Indiana USA. GAMP® Forums are regional workshops intended to serve ISPE Members and non-members of smaller companies that cannot attend global meetings. I was the GAMP® Session Leader for the 2009 Washington Conference, a speaker for GAMP® New Jersey and Brussels Conferences in 2011, and I am a previous Co-Chair of the Joint Equipment and Transition Team (JETT) which is a GAMP® Special Interest Group (SIG).
I have been fortunate to meet a lot of good people during my time with ISPE, and I’ve built good relationships. Participating on these committees has helped me to grow professionally in the process. I am grateful for these experiences and the exposure. Spending time planning conferences and traveling together allows you to get to know the people from the inside, and I am proud to be a part of this professional organization. The people make ISPE as great as it is today.
ISPE is a great place to grow and contribute to realize your full potential.
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.