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Taught by Auditing SMEs 'From the Auditor's Perspective'
Your annual cGMP Training at home, at your convenience.
Sign up today to secure your seat! |
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.
*** Includes Travel (US Only), Workbooks and Certificates |
GMP Workbook

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Course Agenda:
please see brochure for times
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 Predicate Rules
- The History of GMP, the FDA Agency, Agency Inspections, Warning letters and 483s
- Warning Letter Reviews (Review of actual violations)
- Quality Terminology
The QMS Basics
- CAPA - Everything you wanted to know about CAPA,
- Non-Conformance - From Materials Supply to Production,
- Deviations - Deviation management is essential for every company,
- Change Control - Documentation, Engineering, Production and Distribution,
- Out of Specifications / Out of Trend - Correct Management of OOS and OOT for regulated industry,
- Complaints - Receipt, Qualifications, Risk Assessments and Remediation/Resolution,
- Product Traceability - The most under-rated requirement in the industry today,
- Recalls - The process, rationale for plan for success,
- Quality Review and Management Review - Processes for meeting the requirements for annual reviews,
- Vendors, Suppliers, Contractors and Consultants; The Qualification Process explained. The Quality Agreements,
- The 11 General Orders / Principals of GMP
- Writing Procedures (with template examples);
- Following Procedures (and the failures that occur);
- Documentation (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 (Maintenance, Calibration, Use and Cleaning of Facilities/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 Requirements
- 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)
- Validation
- Copies of records
- Protection of records
- Limiting system access
- Audit trails
- Operational system checks
- Authority checks
- Device checks
- Education, Training, Experience
- Policies and Procedures
- Systems documentation
- Microsoft Excel
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