Specialist in Pharmaceutical GMP Compliance Training Consultation

Executive Director John Y. Lee
Mr. Lee is a former FDA Investigator. His area of expertise includes pharmaceutical and API GMPs, pre-approval inspections and sterile products. He specializes in the development of practical GMP training courses and workshops.

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About Pharmaceutical Compliance Associates

Pharmaceutical Compliance Associates (PCA) specializes in compliance consultation relating to current Good Manufacturing Practice (GMP) regulations and Food & Drug Administration (FDA) requirements. Services offered by PCA include compliance audits and mock FDA inspections, establishment and implementation of quality assurance programs, development and review of validation studies, investigation and resolution of compliance and quality problems, compliance review of facilities and equipment design, and development and presentation of employee training programs.

PCA's consultation and training services are conducted by professionals with extensive compliance experience including prior employment with the FDA.

Services

On-Site GMP Training for PharmaNet

Compliance & Technical Audits: Internal GMP Audits | Mock FDA Inspections | Pre-approval (PAI) Inspection Audits| Contractor Audits | Audit Program Development | GMP Compliance Evaluation | Research and Development Compliance Programs

Quality Assurance: Change Control System | Quality Assurance Programs | Document Control System | Product Annual Preview Program | GMP & Technical Training Programs | Batch Record Review System | Process Deviation Investigations | Product Failure Investigations | Batch Release/Rejection Evaluation

FDA Compliance: Responses to FDA Letters & FD-483's | Responses to FDA Regulatory Actions | Correction of FDA Observations | Representation at FDA Meetings

Validation: Design of Validation Studies | Review of Validation Protocols & Reports | Validation Data Review

Facilities: Compliance Review of Facilities & Equipment Design | Coordination for FDA Review & Approval