Navigating Pharma: From FDA Challenges to Consulting with Kimberly Wallbank
Kyle Goodknight introduces Kimberly Wallbank, who shares her expertise on quality systems and navigating FDA consent decree challenges. The discussion covers effective corporate communication, process improvement, and the use of relatable analogies in consulting. Kimberly addresses internal resistance within the pharmaceutical industry and the intricacies of performance reviews and corporate politics. They delve into medical device recalls, FDA reporting, and Kimberly's transition from a corporate role to consulting. She offers entrepreneurial advice, discusses consulting market challenges, and provides an overview of her consulting services.
Key Points
- Corporate environments can often hinder innovation and recognition, leading many professionals to seek more fulfilling entrepreneurial paths.
- Building a strong support system and understanding the financial and emotional costs are crucial for those transitioning to entrepreneurship.
- Documenting processes thoroughly and justifying decisions can save significant time and resources in the long run, especially in regulated industries.
Kimberly Wallbank is a distinguished Quality Systems and Regulatory Consultant with over 27 years of industry experience. She is the founder and owner of Quality Systems Services LLC. Kimberly possesses extensive expertise in guiding pharmaceutical, biotechnology, and medical device companies towards achieving compliance with FDA, EMEA, ISO, and other recognized standards.
LinkedIn: / kimberlywallbank
WEBSITE: https://www.qualitysystemsservices.com/
Her vast experience includes establishing, maintaining, and enhancing quality systems to ensure the delivery of world-class healthcare. As an industry leader, Kimberly adeptly navigates the complexities of FDA compliance while optimizing processes tailored to the unique needs of each business.
Kimberly holds a Bachelor of Science degree from Marquette University and a Master of Business Administration from the University of Phoenix.
Chapters
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Transcript
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