Thursday September 20, 2012 7:30-8:30 P.M. Main Presentation: FDA Mandated Quality Management Systems: Implementation and Challenges, Hugh G. Grimes and Dr. James Capone

Joseph M. Juran in 1987 published the “Cost of Poor Quality” and developed “Juran’s trilogy,” an approach to cross-functional management that is composed of three managerial processes: quality planning, quality control and continuous quality improvement. These functions constitute a Quality Management System (QMS).

In the early 1990s, many ISO industries adopted the QMS approach to meet the needs of their customers.  Whether you work in a regulated or non-regulated industry, effective use of a QMS helps conduct business in a smooth and efficient manner. Come hear answers to the following questions:  When building a quality management system, what are the essential elements, and how do you make these elements connect in a meaningful way?  How does an effective quality system interact with business functions outside its scope?  What are the common gaps in a quality system, and how are they minimized?

Mr. Grimes and Dr. Capone were part of and assisted companies regulated by FDA CDRH when this was mandated for implementation by 21 CFR Part 801 in 1997.  Ten years later, in 2007, FDA mandated (by ICH Q10 guideline) the implementation of QMS for Pharmaceuticals, drug substances, drug products including biotechnology and biological products, i.e. companies regulated by CDER/CBER/CVM.  Now all FDA regulated companies are required to embrace these fundamental principles in one form or another. They will discuss their experiences in the implementation of these QMS and some of the challenges we encountered along the way.

Hugh G. Grimes

Mr. Grimes is a consultant with cGXP Consulting.  He has been actively involved in drugs, medical devices, and biologics for thirty-two 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.

James J. Capone, Ph.D.

Dr. Capone has been actively involved in drugs, medical devices, and biologics for over thirty years. His work experience includes the research, development and manufacture of same as well as extensive management responsibility for microbiology, quality systems and regulatory affairs.  His fifteen years of independent consulting have involved him in the strategic development of quality systems and product approval submissions.    Dr. Capone 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 actions.

Emphasis on the technical aspects of microbiology and sterilization, design, and process validation along with analytical method validations and characterizations including test methods, compendial methods, and immunochemistry. Assists in the development of appropriate quality systems as determined by audit or in response to a regulatory action. International in scope and providing FDA quality systems and regulatory support from start-ups to healthcare corporations with sales in excess of $ 7 Billion annually.

  • Develop master validation plans and validation master plans for all aspects of the device pharmaceutical manufacturing operation.
  • Review, audit and help prepare FDA submissions, i.e., NDA, aNDA, 510(k), PMA.
  • Develop site-specific training for design controls, risk assessment, design of experiments, executive level training to the Quality System Regulations [Parts 211 (Drugs) and 820 (Devices)]
  • 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
  • Process validation protocol development and execution.