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Hugh G. Grimes
 

hggrimes@cGxP.com

http://www.cGxP.com

25 Harbor Drive., Suite101

Vernon Hills, IL, 60061

Practical Compliance Solutions

 (847) 549- 0626 ext.111

 

Mr. Grimes has been actively involved in drugs, medical devices, and biologics for twenty-four years. His work experience includes the research, development and manufacture of same as well as extensive management responsibility for validation, quality systems and regulatory affairs.  His twelve years of independent consulting have involved him in the strategic development of GMP/GLP/GCP/ ISO quality systems, training in all facets of academic/compliance topics, and product approval submissions.    Mr. Grimes specializes in the development of all facets of the quality system including test method and process validation for both domestic and international manufacturers particularly in response to FDA/EU actions/observations.  As such, Mr. Grimes bridges the gaps between Management, Quality/Regulatory Compliance, and Technical Expertise.

Emphasis has been on the technical aspects of chemical, biological, and microbiological test methods and processes.  This included design and process validation along with analytical method validations and characterizations including test methods, compendial methods, and immunochemistry. Assisted in the development of appropriate quality systems, as determined by audit or in response to regulatory actions. International in scope and providing FDA quality systems and regulatory support from start-ups to the largest healthcare corporations.

         Develop master validation plans and validation master plans for all aspects of the device pharmaceutical manufacturing operation.

         Review, audit and help prepare FDA/CE/USP submissions, i.e., NDA, aNDA, 510(k), PMA, CE Mark.

         Develop site-specific training for design controls, risk assessment, design of experiments, executive level training to the Quality System Regulations [21 CFR Parts 211 and 820]

         Develop procedures for general laboratory and microbiological controls for the pharmaceutical and device quality laboratory.

         Develop procedures for method characterization, validation, and method transfer consistent with compendial and non-compendial test methods.

         Design Validation and Verification protocol development and execution

         Test Method, Process, and Cleaning validation protocol development and execution.

         Develop and implement Clinical protocols.

         Instrument/Equipment/ Facilities/ Utilities Characterization and Qualification.

         In general, led assessment, negotiation, development, implementation of Quality System Improvement Plans (QSIP), and managed the execution of highly acclaimed adult-based training for numerous corporations.

 

 

Mr. Grimes has a Bachelors in Chemistry from the Texas A&M University.  Mr. Grimes has completed requirements for a Ph.D. in Medicinal Chemistry.

 

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