Patrick Stone - TradeStone QA LLC | LinkedIn (2024)

• Biosimilar analytical requirements

  

  Biosimilar analytical requirements

  By Patrick Stone

  May 31, 2018

• The Ethical questions we should raise

  

  The Ethical questions we should raise

  By Patrick Stone

  Feb 3, 2017

• Thank you for connecting and interacting

  

  Thank you for connecting and interacting

  By Patrick Stone

  Apr 21, 2016

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• What are the best practices for communicating lab results in a crisis situation?

  The results should be validated and reproducible. The results should be accurate and understandable to the audience. The results should define how any bias or limitations in the data have been reduced or excluded. The quality department management should initiate and.relay the results electronically with return receipt marked as important. This communication process should be implemented and effective. A meeting should be scheduled ASAP.

  Patrick Stone contributed 7 months ago Upvote

Activity

• Got a chance to interview Rossmeri Montalvo and Judy Galindo at ACRP this month. TONS of content from this conference about to drop on my YouTube…

  

  Got a chance to interview Rossmeri Montalvo and Judy Galindo at ACRP this month. TONS of content from this conference about to drop on my YouTube…

  Liked by Patrick Stone

• “Around 300 distinct types of bacteria were isolated across the Roman Baths site—among them the key candidate groups, Actinobacteria and Myxococcota,…

  

  “Around 300 distinct types of bacteria were isolated across the Roman Baths site—among them the key candidate groups, Actinobacteria and Myxococcota,…

  Liked by Patrick Stone

• Great ! ✨🙇‍♀️

  

  Great ! ✨🙇‍♀️

  Liked by Patrick Stone

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• Bubble Gum Badge an FDA His-Story

  Xlibris Publishing July 27, 2011

  This manuscript is a glimpse of what the USFDA does well and what it needs to improve on according to audit reports from the Health and Human Services (HHS) Office of Inspector General (OIG). Here, Stone shares about the documented regulatory affairs 21 CFR compliance experience and advocate for human subject protection and his twelve years of U. S. Food and Drug Administration experience. The book discusses specialized clinical trial regulatory review strategy for oncology therapies…

  This manuscript is a glimpse of what the USFDA does well and what it needs to improve on according to audit reports from the Health and Human Services (HHS) Office of Inspector General (OIG). Here, Stone shares about the documented regulatory affairs 21 CFR compliance experience and advocate for human subject protection and his twelve years of U. S. Food and Drug Administration experience. The book discusses specialized clinical trial regulatory review strategy for oncology therapies (vulnerable patient populations included), cardiovascular disease, HIV, vaccine studies, pain management, and other related health care product subjects.

  See publication

• Black Diamond Network

  Jun 2015

  Clinical Trial GCP, Trial Master File readiness for CMCs & biologics, Gap remediation (GCP/GMP), and Pharma cGMP Quality Assurance projects for Patient Safety in FDA regulated industry (BIMO & GMP including sterile dosage forms).

  Other creators

  See project

• Becker & Associates Consulting an NSF International Company

  Jan 2013 - Present

  A prominently recognized life sciences and FDA regulatory consulting firm specializing in innovative healthcare products.

  Other creators

  See project

• FDA Quality and Regulatory Consultants

  Apr 2012

  International cGMP drug product mock audits (including sterile formulations) and various pipeline GCP phase I-IV projects including TMF readiness PAI. Vendor qualifications for GCP and cGMP.

  Other creators

  See project

• English

  Full professional proficiency

• Spanish

  Professional working proficiency

• Portuguese

  Elementary proficiency

• SQA

  Regional Member Rocky Mountain

  Sep 2001 - Present

  I was a GOV courtesy member as a CSO for FDA. GCP inspections from 2000 until April 2011. https://www.sqa.org/

• Rovia Dream trips

  Travel Executive

  Apr 2011 - Dec 2020

  http://tradestonetravel.rovia.com/rovia/home

• PDA

  Texas Chapter

  http://www.pda.org/

• Kara Lemons Harrison, MS, RAC-US, RQAP-GCP “I have known Patrick since early days at FDA. I have also hired him as a consultant several times since and highly recommend his work. I have always been impressed by his knowledge and understanding of the regs and how they play out in real life. He really understands subject safety, data integrity, and the impact each has on development success.”
• Sara Cordaro-Phillips “I have had the pleasure of working with Patrick on multiple audits of business partners contractors for GCP compliance. He is an expert in FDA/CVM guidances and regulations and willingly shares his knowledge in a polite and professional manner. He delivers high quality results on time and meets or exceeds all expectations set by his clients. I highly recommend Patrick to any company that requires FDA/CVM auditing services.”

• Too busy to make a video today and this is where I am supposed to drop a kindle sized post to: humble brag, elevate my brand, farm for engagement, or…

  

  Too busy to make a video today and this is where I am supposed to drop a kindle sized post to: humble brag, elevate my brand, farm for engagement, or…

  Liked by Patrick Stone

• Respect the fundamentals https://lnkd.in/ggEvhQd7

  

  Respect the fundamentals https://lnkd.in/ggEvhQd7

  Liked by Patrick Stone

• Thanks Gayna B. Whitaker, MBA for sharing your career experiences with Guru Nation. Site and patient advocacy go hand in hand, and the industry is a…

  

  Thanks Gayna B. Whitaker, MBA for sharing your career experiences with Guru Nation. Site and patient advocacy go hand in hand, and the industry is a…

  Liked by Patrick Stone

• https://lnkd.in/gbWt9Tqh

  

  https://lnkd.in/gbWt9Tqh

  Liked by Patrick Stone

• Happy Memorial Day! Felt like putting together some career and site owner FAQs https://lnkd.in/gEvy9Bf3

  

  Happy Memorial Day! Felt like putting together some career and site owner FAQs https://lnkd.in/gEvy9Bf3

  Liked by Patrick Stone

• Liked by Patrick Stone

  

  Liked by Patrick Stone