ADAMAS as SQA TT UploadEducational’, ‘Enlightening’, ‘Thought provoking’……these were, repeatedly, heard comments that were only surpassed by the new relationships that were forged at this year’s 31st SQA Annual Conference held in Tampa, Florida.

More than 750 people attended this year’s annual conference including our ADAMAS Americas team.

Michelle Holbrook, our Head of Business, presented three podium sessions “Verifiable Source: Patient vs. Subject Records”, “Risk Everything: What You Need to Know about What You Don’t Know” and “How to Risk Everything”.

Donna McElcar, a lead Consultant who also heads up Operations, led two all day courses within the Quality College, “Problem Definition Through Root Cause Analysis: Moving Beyond Human Error” and “CAPA Development, Implementation and Confirmation of Success”.

Dana Beck, one of our Senior Consultants, presented her poster “Be Forewarned! Inform with Caution! – Are we enlightening or overwhelming potential subjects?” In fact, she was awarded “Best Poster” for her efforts.

Joined by Dr. Alia Legaux, a lead Consultant and former FDA Inspector; Ian Montague and Steve Bliss, the ADAMAS Team was proud to be a contributor and an attendee at the conference.

The ADAMAS team is part of a global group of full-time, experienced GxP auditors and consultants that includes three former MHRA Inspectors (GCP and GVP). So no matter how many audits or geographies your audits span, ADAMAS provides an independent, unparalleled consistency and quality across all of our audits and projects…which means you can focus more time on other priorities.

If you would like to speak with any of our experts, including former FDA and MHRA Inspectors, or to learn more about ADAMAS, give us a call at +1-919-341-3361 or contact Steve Bliss at steve.bliss@adamasconsulting.com.

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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