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WR Tolbert & Associates, LLC
William Tolbert
11483 Cy●●●●●●●●ds Drive
San●●●ego , CA, 92131-3535
UNITED STATES
View this contact
WR Tolbert & Associates, LLC
William Tolbert
11483 Cy●●●●●●●●ds Drive
San●●●ego , CA, 92131-3535
UNITED STATES
View this contact
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cGMP/QRS/GLP Consulting | wrtolbert.com Reviews
https://wrtolbert.com
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wrtolbert.com
Manufacturing
http://www.wrtolbert.com/manufacturing.htm
Our firm has extensive experience in research, development and production of products derived from mammalian cell substrates, e.g. monoclonal antibodies and recombinant proteins. We also have experience with cell and gene therapy modalities. W. Tolbert is an inventor on 26 US Patents related to cell culture technology. And to cell derived products. For 10 years he held vice president positions.
Audit
http://www.wrtolbert.com/audit.htm
Auditing functions are the responsibility of the Quality organization. Our firm provides assistance in the following areas:. Contractor and vendor audits. Preparation of a pre-audit questionnaire to request specific information from the contractor or vendor. Preparation of an audit report including any negative observations or audit findings. The report will contain a summary evaluation of the contractor or vendor's compliance status and recommendations. Preparation for a regulatory inspection. On-site m...
Services
http://www.wrtolbert.com/services.htm
Our firm provides a number of consulting services, which are described in detail under the WebPages shown above. A short description of each is listed below:. Our firm has completed conceptual facility design plans for 40 manufacturing facilities, including 30 facilities for cell and gene therapy products. We work with our clients to define their specific needs and to provide a facility design optimized for those needs that also meets FDA cGMP/QSR/GTP requirements, as appropriate. CGMPs, GTPs, QSRs and G...
About Us
http://www.wrtolbert.com/about_us.htm
William R. Tolbert, President of WR Tolbert and Associates, LLC has been an independent consultant in cGMP manufacturing, specializing in cell-derived biopharmaceuticals for over a decade. His corporate experience includes 10 years in executive positions at Invitron, Centocor and Advanced Tissue Sciences with responsibility for. Earlier he held the position of Monsanto Fellow associated with the Monsanto/Harvard University research project on tumor angiogenesis. In addition to the biographical informatio...
Quality Services
http://www.wrtolbert.com/quality.htm
An independence Quality organization. Is a fundamental requirement for regulatory compliance under cGMPs, QSRs, GTPs and GLPs. We assist in the development and review of our clients' quality organizations and participate in preparation of suitable documents and document control systems. The quality organization must have the authority to fulfill the following regulatory tasks and responsibilities:. Approve or reject all bulk substance (active pharmaceutical ingredient - API) and final products. Documente...
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cGMP/QRS/GLP Consulting
CGMP / GTP / QSR / GLP Consulting. Our firm helps commercial and academic organizations navigate their course through the FDA laws, regulations and guidelines that are required for success within this highly regulated and challenging environment. We specialize in the manufacture of products made or associated with cell-based technology:. Gene Therapy and Cell Therapy. This website includes information about our consulting services. The Federal Food Drug and Cosmetic (FDC) Act (1938 - Drugs and Biologics).
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W R Toole Engineers - Civil Engineering Planning
