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