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Accomplishments

GMP Quality System Design

Quality System Improvement

Regulatory Affairs

Training and Instruction

GMP Quality System Design

• Directed the design, staffing and implementation of companies such as:

  • startup combination medical device & pharmaceutical manufacturing and packaging operation

  • active pharmaceutical ingredient and a drug product manufacturing facility    

  • virtual biotech company

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Quality System Improvement and Remediation

• Reconstructed the quality system of a medical device contract manufacturing site

• Recommended and implemented solutions to compliance issues resulting from a consent decree and/or warning letters

• Designed & implemented supplier & outsourcing programs

• Guided the restructuring of material flow that reduced scrap 30% and labor 20%, thereby increasing overall productivity by 20%

• Streamlined the fabrication, assembly, and packaging of medical devices that reduced labor by 20% and increased output by 15%

• Initiated quality planning system for new product development that tracked design, development, prototype, scale-up and validation.

• Led a cross functional team to qualify a monoclonal antibody (MAB) contractor for a life-sustaining biological

• Initiated a corporate-wide statistical process control for an international corporation

• Assisted in leading an ad hoc quality group to establish a corporate quality facilities management function

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Regulatory Affairs

• Successfully submitted pharmaceutical and medical device submissions to FDA & Health Canada

• Persuaded FDA to reclassify a product from drug to medical device and guided efforts to obtain approval via the 510K route

• Successfully petitioned NRC medical committee to amend regulations adding palladium as a standard radioisotope for medical use

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Training & Instruction

• Directed the training for personnel in a combination medical device and drug facility to include on-the- job and GMP training.

• Assisted in leading a large pharma’s ad hoc GMP Training Improvement team to improve introductory GMP training

• Instructed GMP classes for a large pharma company and received very high class evaluations.

• Developed GMP training courses based on CFR Parts 210 & 211 and Part 820

• Assisted division of a large pharma manufacturer to establish an effectiveness based training program

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