At QLeaR Advisors, we like to exceed expectations. We don’t just fix problems, we enable quality teams with information to help them successfully implement intelligent ways to meet the regulatory hurdles without breaking the bank or the spirit of those involved.
At QLeaR, we thrive on working across functions to obtain optimal business outcomes that meet regulatory requirements, and we have fun doing it. We are experts in compliant and efficient solutions and can provide invaluable regulatory leadership skills and coaching.
Check out what’s in our bag of tricks
Medical Device and Pharmaceutical companies who need QMS support
Quality / Compliance Leadership Coaching
Training
Regulatory Strategy and Submission Support
IT Software Implementation
Change Management
GCP, GMP, and GLP
FDA Inspection Readiness
Due Diligence
Remediation
Happy Clients
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Their knowledge base of regulatory and ISO standards is excellent; consulting services are immediate, reliable, and extremely helpful!
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They have a good practical sense of what is required, in addition to a great knowledge of quality standards.
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They have a diverse knowledge, are easy to work with, have prompt communication, and provide candid input and assessments.
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They helped without being too judgemental.
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Jackie has significant depth of QC experience, is organized, and sees the big picture. She engaged with people incredibly well. From what I heard from my staff, Jackie calmed people down and built up their confidence. Her expertise and empathy allowed her to create the right strategy and a strong training program quickly.
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Jackie brought together representatives from different departments and had them work on real-world investigation scenarios. There was no lecturing. It was ‘hands-on’ training. People could brainstorm and problem solve together – as they would during actual investigations.
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Jackie provided a planned, systematic approach towards lab investigations. The training helped the team to brainstorm the root causes of a problem better, narrow it down, and also offered tactics to write a good problem statement.
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The training Jackie provided was excellent! She was knowledgeable, organized, and easy to follow. Our team will be able to apply all of the knowledge learned.
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Jackie helped to stem the attrition from the QA and QC teams. As a result, both teams felt more confident and capable when thinking about and writing up investigation reports.