Windshire Consulting is thrilled to share that our esteemed President, Dr. James Blackwell, has joined The Center for Professional Innovation & Education (CfPIE) as one of their expert educators. March 11-14 2024
Dr. Blackwell will be leading two highly anticipated courses this year, catering to professionals in the life sciences industry:
- CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines
- CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies, & Biosimilars
These courses offer invaluable insights and strategies essential for navigating the regulatory landscape of these cutting-edge fields. Whether you’re involved in cell and gene therapy medicines or the manufacturing of recombinant proteins, monoclonal antibodies, and biosimilars, Dr. Blackwell’s expertise will provide you with the knowledge and skills needed to excel in your role.
For more information on these courses and to secure your spot, please visit the following links:
CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines
CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies, & Biosimilars
Don’t miss this incredible opportunity to learn from Dr. James Blackwell and elevate your expertise in the life sciences field! Secure your spot today and embark on a journey of professional growth and development.
For more information, please contact The Windshire Group at (+1) 844-686-5750, by email info@windshire.com, or visit our website at www.windshire.com.
Windshire Consulting is thrilled to share that our esteemed President, Dr. James Blackwell, has joined The Center for Professional Innovation & Education (CfPIE) as one of their expert educators. March 4-7 2024
Dr. Blackwell will be leading two highly anticipated courses this year, catering to professionals in the life sciences industry:
- CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines
- CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies, & Biosimilars
These courses offer invaluable insights and strategies essential for navigating the regulatory landscape of these cutting-edge fields. Whether you’re involved in cell and gene therapy medicines or the manufacturing of recombinant proteins, monoclonal antibodies, and biosimilars, Dr. Blackwell’s expertise will provide you with the knowledge and skills needed to excel in your role.
For more information on these courses and to secure your spot, please visit the following links:
CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines
CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies, & Biosimilars
Don’t miss this incredible opportunity to learn from Dr. James Blackwell and elevate your expertise in the life sciences field! Secure your spot today and embark on a journey of professional growth and development.
For more information, please contact The Windshire Group at (+1) 844-686-5750, by email info@windshire.com, or visit our website at www.windshire.com.
For Immediate Release – Thursday, September 1, 2016
The Windshire Group, LLC Launches New CMC Information-Related Website
(Woburn, MA) The Windshire Group, LLC announced today the launch of its new CMC-information related website. “The focus of the website is for it to become an information destination for Chemistry, Manufacturing and Controls (CMC)-related topics for Quality professionals,” said James Blackwell, Ph.D, M.B.A., Founder and President. “We believe there is a significant need to educate professionals on CMC-related topics and to share information in a public forum,” he said.
The website will include a weekly blog. “The first published blog is entitled “What Does CMC Mean.” We also expect our website’s content to include on demand webinars, presentations, whitepapers, SOP templates and much more for today’s busy professional,“ he said.
What Makes The Windshire Group Different?
“Our niche is comprehensive CMC and related management consulting,” Dr. Blackwell said. “The Windshire Group’s consultants, products and solutions deliver best in class results. We are tenaciously committed to the success of our clients who develop, manufacture, deliver, and invest in medicines, treatments, and other products in regulated life science industries,” he said.
For more information, please contact The Windshire Group at (+1) 844-686-5750, by email info@windshire.com, or visit our website at www.windshire.com.
The Windshire Group Launches StabilityshireSM
NEEDHAM, MA–(Marketwired – Sep 4, 2015) – The Windshire Group, LLC, a global consulting group providing comprehensive consulting services to biopharmaceutical, pharmaceutical, medical device, cell therapy companies and industry investors, today announced the launch of Stabilityshire(SM), a drug stability and shelf-life data analysis, assessment, reporting and management service. The service allows organizations to supplement internal capabilities, or to completely outsource their stability data management and analysis requirements, while accessing world-class expertise.
The StabilityshireSM service evaluates stability data to determine the appropriate shelf-life for new drugs, and to monitor ongoing stability performance. The service is fully compliant and based on a cGMP quality system, and uses fully validated trend analysis software that is compliant with cGMP, ISO and ICH Q1E requirements. It produces stability reports, including trend analysis, and provides authorship of the stability sections of regulatory submissions — such as INDs, IMPDs and NDAs. The service can manage entire stability programs, including outsourcing and stability testing at CROs and CMOs. For current or ongoing stability programs, StabilityshireSM can also assess these for cGMP and ICH compliance.
“We have been very pleased with our clients’ response to the StabilityshireSM service offering,” said James Blackwell, Ph.D., President and Principal Consultant, The Windshire Group. “It is an excellent complement to our comprehensive consulting services and increases our ability to meet our clients’ drug development and compliance needs. It also fits our long term strategy to offer industry leading comprehensive data analysis and management services, such as our Continued Process Verification offering for ongoing process and manufacturing data analysis and management”
For more information, please call +1-844-686-5750 or email info@windshire.com