FDA inspectors recently raised concerns over the conduct of multiple trials with the same investigational medicinal product (IMP) under the oversight of the same investigator. A warning letter was issued to one such investigator, as the FDA observed delays in...
Dana Beck, one of our leading Consultants for ADAMAS Consulting in the Americas, was recently honoured by the Society of Quality Assurance and awarded the “Best Poster” accolade at the SQA 2015 Annual Conference held in Tampa, Florida the week of April 12th. Her...
Educational’, ‘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...
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...
ADAMAS Consulting is an independent, global consultancy with an 18 year history of providing our clients with expert Auditing, Quality Assurance (QA) and Quality Management System (QMS) consulting. With the largest group of full-time auditors on staff located...
ADAMAS Consulting will be exhibiting at the event in Tampa on the 12th to the 17th of April. Come and meet ADAMAS Directors and Consultants at booth #102 to talk about Services & Solutions we can provide to benefit your business.
Standard Operating Procedures (SOPs) are critical for any company operating within a regulated environment. However SOP non-compliance or deficiencies are still one of the most common audit or inspection findings made by auditors or regulatory inspectors,...
We would like to take this opportunity to wish our readers, clients and partners continued success going forward into 2015. We are looking to develop our blog this year going from one posting a month to at least two a month. We are grateful to our readers and hope...
Season's Greetings from all of us at ADAMAS. We would like to thank you all for following our blog over the course of the last year and hope you will continue to do so in 2015. Please click the link below to see our Christmas Card. Click here to see the ADAMAS...
On 25-Apr-14, the MHRA issued a press release indicating that the definition of a critical GCP inspection finding had been changed. It now includes ‘Where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily...
From Reactive Compliance to Strategic Partnership: How Clinical Quality Is Evolving
RQA 8th Global QA Conference 2026 | London, UK
FDA’s Real-Time Clinical Trial Initiative: Endorses Data-Enabled QA Oversight
SCOPE Europe 2026 | Barcelona, Spain
Beyond Audit Cycles: A Risk-Based Approach to Regulatory Excellence in Pharmacovigilance