Member Spotlight: Waunetka Clark
Where did you go to college/university and what was your major?
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.
What attracted you to pharmaceutical engineering?
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.
When did you join ISPE, and what are some great memories you have of being involved?
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.
What are you working on now?
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.
What are you working on with ISPE as a volunteer? How is it going?
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.
Any other comments about volunteering, ISPE, or the future of the industry?
ISPE is a great place to grow and contribute to realize your full potential.