Kelly Brogan is a reliable, well-organized consultant/facilitator with more than 20 years experience in the pharmaceutical industry. Her responsibilities have included manufacturing, packaging, QC/QA, materials management, Standard Operating Procedure (SOP) writing and training, and GMP compliance.

Focused and thorough, Kelly advances task completion while ensuring that methodology is sound and results are accurate. Her wide-ranging pharmaceutical experience, her strong coaching skills, her friendly nature, and her scrupulous attention to detail make Ms. Brogan a valuable addition to any team.

Technical Writing

• Responsible for development and streamlining of over 150 SOPs for an innovative mid-sized pharmaceutical company, ensuring FDA and Health Canada (HPFBI) regulatory requirements were met. Other tasks included ensuring currency of existing SOP manuals and development of a database for safety, SOP, equipment, and process training materials.
• Coordinated development and writing of SOPs for major pharmaceutical manufacturers, ensuring compliance with GMPs and cGMPs. Developed associated training.
• Produced documentation and SOPs for a medical device importer and distributor, drug fabricator, packager, testing laboratory, importer, distributor, and wholesaler.

Quality Assurance/Quality Control Officer (QCO) Services

• Completed deviation/investigation and change control reports for numerous large and small pharmaceutical companies; provided batch documentation review; wrote manufacturing and packaging directions ensuring adherence to GMPs, SOPs, and safety procedures.
• Set up quality assurance systems for several importers/distributors.
• Prepared and maintained Site Reference Files.
• Coordinated product testing.
• Handled correspondence and communication with Health Canada.
• Hosted numerous successful HPFBI audits.

cGMP Training

• Developed and delivered GMP Fundamentals, Deviation, Hygiene, and Sanitation OOS training programs to over 1,500 employees of large pharmaceutical manufacturer.
• Delivered SOP, GMP, on-the-job, and safety training to employees at several major pharmaceutical manufacturers and several importers/distributors.
• Developed Good Quality Practices training course for medical device company.
• Developed and delivered a GMP training course for a major herbal company to NNFA specified standards.

cGMP Auditing

• Provided auditing services for numerous large and small pharmaceutical companies and API suppliers; performed self-inspections, hosted successful Health Canada audits.
• Participated in FDA audit of a large Canadian pharmaceutical fabricator.
• Performed gap analyses of foreign fabricators to Canadian GMP standards.

Consulting

• Experienced in a range of situations, including the following:
  • Design of new manufacturing facility.
  • Importation of pharmaceuticals from international suppliers.
  • Coordination and supervision of third-party product suppliers.
  • Leadership of process re-engineering team.

• Food and Drug Technology (3-year program), Durham College

• Advanced GMP Auditing
• Audit Skills
• Clinical Trial Overview/Introduction to Quality Assurance
• Deviations and Change Control
• Drug System Setup (Importer)
• Fundamentals of Regulatory Affairs, CanReg
• GMP for Importers/Distributors, Q&C
• GMP for Wholesalers, Q&C
• GMP Guidelines 2002 Edition workshop
• HPFBI Audit Management
• ICH Stability Guidelines
• Industrial Drug Legislation, Seneca College
• Introduction to Clinical Quality Assurance, PSG
• Introduction to ISO 9001:2000, Q&C
• Langevin Training Generalist Certificate
• Level I Certificate of Achievement, PSG
• Looking Through the Glass Into Our Changing Future, PSG
• Pharmaceutical Label Review, CanReg
• Product Disposition, Q&C
• QMI Internal Auditor for Manufacturing
• Review of Changes to Risk Classification for GMP Observations, Q&C
• SOP Writing
• Technical Writing Course, Q&C
• Total Quality Advantage Facilitator Course, ODI, Boston
• Training Needs Analysis Workshop