Tampa is well known for its professional wrestlers, but next week the ADAMAS team will be showing off our skills at SQA 2015. Meet our team, including a former FDA Inspector, two SQA 2015 Conference Speakers & Educators, and a poster presentation by one of our expert Auditors.

Michelle Holbrook, our Head of Business for The Americas will be presenting three podium sessions “Verifiable Source: Patient vs. Subject Records” with Deidre Poucher from Vertex Pharmaceuticals on Tuesday, April 14th, “Risk Everything: What You Need to Know About What You Don’t Know” and “How to Risk Everything” on Wednesday, April 15th with Angela Berns of UCB Biosciences.

Donna McElcar, a lead Consultant who also heads up Operations for the Americas Team, will be leading 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 will be supporting her poster presentation “Be Forewarned! Inform with Caution! Are we enlightening or overwhelming potential subjects? “

Dr. Alia Legaux, formerly an FDA Inspector, has recently joined the ADAMAS Americas Team to bring her insights and experience to conduct audits, mock inspections and training, and provide the inside Regulatory Agency perspective and guidance for our clients.

The ADAMAS Americas team is part of a global group of full-time, experienced GxP Auditing and Consulting firms that also includes three former MHRA Inspectors (two with MHRA 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 more time for you to focus on your other priorities.

If you’re attending the conference in Tampa, stop by Booth #102 to engage with the ADAMAS Americas team in person. Speak with a former FDA inspector, bring your compliance and QA challenges to our professional experts and auditors, and enter our raffle for a GoPro Hero HD Action Camera.

If you’re not attending but would like to learn more about ADAMAS, give us a call at +1-919-341-3361 or contact Steve Bliss at steve.bliss@adamasconsulting.com.

See you there.

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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