​FDAWEBTRAINING.COM is a subsidiary of Guerra Consulting Group, Inc.™ (GCGI™). GCGI™, established since 1999, provides full time regulatory services to the Pharmaceutical, Active Pharmaceutical Ingredient (API), Biotechnology, Medical Device, Discovery Work and R/D industries in USA, Canada, Europe, China, Korea, India, Japan and other countries.

FDAWEBTRAINING.COM services are conducted by Johnny Guerra, drawing from “20 Years of FDA Experience and Knowledge™”, and additional 22 Years of International Consultancy offering excellency on client needs, task execution, problem solving and timely completion of studies, analysis, projects and presentations.

Before accepting a web-based project, FDAWEBTRAINING.COM will confer with the client in sufficient detail to understand its scope. The recommendations are performed on an individual basis and developed specifically for the practical solution of each client’s problem. 

FDAWEBTRAINING.COM provides FDA-oriented regulatory web consulting, web training and
web hosting moderator services to Manufacturing, Laboratory, Technical Service, Engineering, Validation, IT, QA, Training, Calibration and Process Excellence Departments in the following areas:

  • Response to FDA-483s.
  • Response to FDA Warning Letters.
  • Failure Investigations, Root-Cause-Analysis (RCA) and Problem-Solving Techniques (PST).
  • Evaluation of Corrective and Preventive Action Plans (CAPA).
  • Human Error Detection, Correction and Prevention’s Program.
  • Laboratory CGXP and Manufacturing CGMP Controls.
  • Data Integrity in Laboratory and Manufacturing Operations.
  • Line Clearance, Mix-Ups, Mix Labels, Short Fill and Complaint Events.
  • Master Certification Plan for Laboratory Analysts (MCPLA).
  • Master Certification Plan for Manufacturing Personnel (MCPMP).
  • Master Computer Systems Validation (CSV) Certification Program.
  • Master Validation Plans and Change Control Program.
  • Process Analytical Technology (PAT) and Vendor Audits.
  • Electronic Records; Electronic Signatures (21 CFR Part 11).
  • Cleaning Validation Program.
  • Drug Master Files (DMF) and NDAs.
  • Mock Pre-Approval Inspections (PAI) and Facilities Planning and Design.

Tel: +1 (833) FDAWEBS        +1 (833) 332-9327

email: info@fdawebtraining.com

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