Waunetka Clark, ISPE Member Spotlight

 

Name:  Waunetka A. Clark
Title: Principal Quality Engineer
Company Name:  AbbVie

 

 

Where did you go to college/university and what was your major?  

I received a Bachelor of Electrical Engineering from Tuskegee University and a Master’s Certificate from Purdue University in Quality and Regulatory Compliance.

What attracted you to pharmaceutical engineering?

When I graduated college, I had no prior knowledge of the pharmaceutical 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 recently been a part of the program planning committee for 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.

RELATED POSTS