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José García Consulting LLC

Training

Effective compliance training must connect regulatory requirements with the decisions employees make every day.

GMP

Good Manufacturing Practice

Core GMP expectations for the people who make, package, test, and release product.

GDP

Good Documentation Practice

Accurate, attributable, contemporaneous records, including corrections, dates, and witnessing.

DI

Data Integrity

ALCOA+ principles, audit trails, and user access across paper and electronic records.

QC

QC Laboratory Equipment Coaching

Hands-on coaching for analysts in operating and troubleshooting laboratory equipment.

Customized to your site. Programs can be built around your SOPs, FDA observations, Warning Letter themes, Data Integrity findings, CAPA programs, and site-specific documentation practices.

Participants gathered after an on-site GMP, GDP, and Data Integrity training session
An on-site GMP, GDP, and Data Integrity training session.

900+

Personnel Trained

During a single on-site GMP, GDP, and Data Integrity compliance initiative across multiple operational shifts.

  • 24Training Sessions

Need Practical GMP and Data Integrity Training?

Tell us about your site, your procedures, and your objectives, and we will shape a program around them.

Discuss Your Compliance Needs