About
I've spent the majority of my career in quality, auditing, and QA consulting. With 15…
Articles by Amy
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Ensuring Data Integrity and Risk Mitigation: The Role of Quality Assurance Audits
Ensuring Data Integrity and Risk Mitigation: The Role of Quality Assurance Audits
By Amy Wotawa
Contributions
Activity
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The conclusion to a challenge years in the making. There are so many parallels between business & sports... As a shorter kid growing-up my dad…
The conclusion to a challenge years in the making. There are so many parallels between business & sports... As a shorter kid growing-up my dad…
Liked by Amy Wotawa
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When does Monday come before Sunday? In the dictionary. 1️⃣ FDA published "Reprocessed Single-Use Devices: Frequently Asked Questions" 𝘞𝘩𝘢𝘵…
When does Monday come before Sunday? In the dictionary. 1️⃣ FDA published "Reprocessed Single-Use Devices: Frequently Asked Questions" 𝘞𝘩𝘢𝘵…
Liked by Amy Wotawa
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This is very much needed as a reminder since I had a big vacation weekend. Back to real life and a strong diet!
This is very much needed as a reminder since I had a big vacation weekend. Back to real life and a strong diet!
Liked by Amy Wotawa
Experience
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Education
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The Johns Hopkins University
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Activities and Societies: Content contributor, Hopkins Biotech Network newsletter, The Transcript
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Activities and Societies: Beta Beta Beta Biology Honor Society Officer & Member, Chancellor's Award Recipient for Academic Research
Licenses & Certifications
Courses
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Advanced Cell Biology I
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Advanced Cell Biology II
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Biochemistry
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Cancer Biology
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Gene Organization & Expression
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Human Molecular Genetics
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Leading Change in Biotechnology
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Managing and Leading Biotechnology Professionals
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Molecular Biology
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NIDA Clinical Trials Network Good Clinical Practice
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Principles of Immunology
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SQA GLP 104 - Auditing Techniques
GLP 104
Organizations
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American Society for Quality (ASQ)
Professional Membership: Quality Management Division; Food, Drug, and Cosmetic Division; Audit Division
- PresentASQ is a global organization with members in more than 130 countries and consists of member-led communities that help members connect with other quality professionals and practitioners, advance their knowledge and careers, and grow as thought leaders.
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Huntsville Women for Good
Founding Member
- PresentHelping women in Huntsville, Alabama build connections, enrich our professional and personal lives while doing good for the greater community. We come together once every quarter to network, donate, learn about local nonprofits and vote on which ones to support together through our giving circle.
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Society of Quality Assurance (SQA)
Active Member: Good Laboratory Practice Specialty Section; Quality Assurance Consulting Support Specialty Section
- PresentAn association of over 2,000 QA professionals who are dedicated to implementing Good Clinical Practices (GCPs) Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs) in industry, government, academia and consulting.
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https://lnkd.in/e-2YkUCr
https://lnkd.in/e-2YkUCr
Posted by Amy Wotawa
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On July 25, the FDA issued final guidance on Real-World Data (RWD). The guidance is designed to help sponsors use RWD from EHRs and medical claims…
On July 25, the FDA issued final guidance on Real-World Data (RWD). The guidance is designed to help sponsors use RWD from EHRs and medical claims…
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I appreciate quality managers and directors who go out of their way to: ↳ Give clear, constructive feedback to help teams grow. ↳ Create a…
I appreciate quality managers and directors who go out of their way to: ↳ Give clear, constructive feedback to help teams grow. ↳ Create a…
Liked by Amy Wotawa
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Inflation continues to cool (PCE rose just 0.1% in June)... Wage & Salary Growth halved in June to 0.3%... Meanwhile, U.S. Consumer Sentiment…
Inflation continues to cool (PCE rose just 0.1% in June)... Wage & Salary Growth halved in June to 0.3%... Meanwhile, U.S. Consumer Sentiment…
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WHO's Plan for Improving Global Clinical Trials The recent World Health Organization clinical trials stakeholder consultation held on June 18-19…
WHO's Plan for Improving Global Clinical Trials The recent World Health Organization clinical trials stakeholder consultation held on June 18-19…
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Correction vs. Corrective Action - What's different? And How to tell them apart? In a recent training I gave, I asked participants how confident…
Correction vs. Corrective Action - What's different? And How to tell them apart? In a recent training I gave, I asked participants how confident…
Liked by Amy Wotawa
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Business travel looks glamorous on the surface, but very quickly becomes a chore. Unfortunately most people only see the hotel and convention center…
Business travel looks glamorous on the surface, but very quickly becomes a chore. Unfortunately most people only see the hotel and convention center…
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If your training strategy isn't addressing these 13 key challenges, it might be time for a serious overhaul: 1. Lack of understanding of individual…
If your training strategy isn't addressing these 13 key challenges, it might be time for a serious overhaul: 1. Lack of understanding of individual…
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FDA has approved a cell therapy treatment for synovial sarcoma, a rare form of soft tissue cancer. #fda #celltherapy #raredisease #biotech
FDA has approved a cell therapy treatment for synovial sarcoma, a rare form of soft tissue cancer. #fda #celltherapy #raredisease #biotech
Liked by Amy Wotawa
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