Taught by Auditing SMEs 'From the Auditor's Perspective'
Your annual cGMP Training at home, at your convenience.
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Download the Brochure and Agenda
8-hour cGMP Boot Camp 101 focuses on;
- The cGMP Basics 101
- Part 11 Electronic Records; Electronic Signatures
- The Auditor's Basics
- The QMS Requirements
- The 11 General Orders
* Presentation and Certificates will be emailed
** Verification will be performed using GoToWebinar Analytics.
Course Agenda Download the Brochure and Agenda - please see brochure for times.
GMP QMS 101 The Basics - The required GMP / QMS Training for all employees!
- GMP - What is cGMP and the GMP Lifestyle?
- The History of GMP, the Agency Inspections and 483s
- Warning Letter Reviews (Review of actual 483 violations and warning letters)
- The 11 General Orders or Principals of GMP
- Writing Procedures (with template examples)
- Following Procedures (and the failures that occur)
- Documentation (Rationale, Requirements and the Regulations)
- Validation (Concepts, and basic process requirements)
- Design/Build Facilities and Equipment (In depth look into a GMP facility requirement)
- Maintain Facilities and Equipment (The Maintenance, Calibration, Use and Cleaning of Facilities and Equipment
- Competency (The Training Requirements)
- Sanitation and Good Housekeeping Practices (General requirements for all facilities)
- Control for Quality (from Materials Receipt, Production, Packaging and Distribution)
- Audit for Compliance (Basic Audit Concepts)
- Prepare for BATTLE! - The Traceability Audit!
Good Auditing Practice
- The Auditor's Basics 101 'From the Auditor's Perspective'
- The 5 Basic Binders
- The Quality Manual
- IT Strategy Plan
- Standard Operating Procedures
- Validation Documentation
- Drug/Device Documentation
The QMS Basics
- CAPA - Everything you wanted to know about CAPA,
- Non-Conformance - From Materials Supply, to Production to End of Use Complaints,
- Change Control - Documentation, Engineering, Production and Distribution,
- Deviations - Proper deviation management is essential for every company,
- Out of Specifications / Out of Trend - Correct Management of OOS and OOT for regulated industry,
- Complaints - Receipt, Qualifications, Risk Assessments and Remediation/Resolution,
- Recalls - The process, and rationale for success, and indications of failures,
- Product Traceability - The most under-rated requirement in the industry today,
- Audit - Internal, Agency, Customers and External Audit - Receiving, Conducting, and Self Assessments,
- Vendors, Suppliers, Contractors and Consultants - The Qualification Process explained. The Quality Agreements,
21 CFR Part 11 Electronic Records
- 21 CFR Part 11 Basic Overview
• 21 CFR Part 11 Definitions, System Types and Classifications
• 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
• Part 11.10 Sections a) - k)
- - Validation
- - Copies of records
- - Protection of records
- - Limiting system access
- - Audit trails
- - Operational system checks
- - Authority checks (h) Device checks
- - Education, Training, Experience
- - Policies and Procedures
- - Systems documentation
• Scope and Application Risk Analysis - Determine Which Systems Need to be Validated
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