GMP Boot Camp Training Certificate and GMP Handbook

3 popular regulations in an easy to carry pocket handbook.

US FDA Title 21 CFR Part 11 Electronic Records; Electronic Signatures and includes Scope and Application 2003 - FDA Interpretation of Part 11 Requirements.

US FDA Title 21 CFR Parts 210/211 Good Manufacturing Practices - The regulations set forth in parts 210/211 contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug product.

US FDA Title 21 CFR Part 820 Quality Systems Regulation The methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

Training Curriculum:

Course Agenda

GMP QMS 101 The Basics - The required GMP Training for all employees who work in regulated industry.

• GMP and the GMP Focus and the GMP Lifestyle
• The FDA Agency, Inspections, Warning letters and 483s
• Quality Terminology

The QMS

• The Basics of QMS
• CAPA - The basics about Corrective and Preventive Actions;
• Non-Conformance - Materials, Specifications, and Quality;
• Change Control - Documentation, Engineering, Production and Distribution;
• Deviations - Deviation management essentials;
• Out of Specifications / Out of Trend - Management of OOS and OOT;
• Complaints - Receipt, Qualifications, Risk Assessments and Remediation/Resolution;
• Recalls - The process, and indications of failures;
• Product Traceability;
• Audit - Internal, Agency, Customers and External Audit;
• Vendors, Suppliers and Contractors - Quality Agreements;
• The Meetings - Management and Quality Meetings;
  
  
• The 11 General Orders / Principals of GMP
  1. Writing Procedures (with template examples);
  2. Following Procedures (and the failures that occur);
  3. Documentation (Requirements, and the Regulations);
  4. Validation (Concepts, and basic process requirements);
  5. Design/Build Facilities and Equipment (In-depth look into a GMP facility requirement);
  6. Maintain Facilities and Equipment (Maintenance, Calibration, Use and Cleaning of Facilities/Equipment);
  7. Competency (The Training Requirements);
  8. Sanitation and Good Housekeeping Practices (General requirements for all facilities);
  9. Control for Quality (from Materials Receipt, Production, Packaging and Distribution);
  10. Audit Requirements
  11. Prepare for Battle! The Traceability Process;

21 CFR Part 11 Electronic Records

• 21 CFR Part 11 Basic Overview
• Definitions, System Types and Classifications
• 21 CFR Part 11 – Predicate Rule
• Part 11.10 Sections a) - k)
• Microsoft Excel

**Must satisfy 7-hours on-line attendance to receive Certificate of Attendance