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July 7th, 2022 - FREE GMP QMS 8-Hour Webinar

Download the Brochure and Agenda

Get an All- Inclusive 'On-Site' 8-Hour GMP/QMS Bootcamps for $4,995.00! Up to 20 Attendees***

*FREE Seat Registration

*Due to limited seats a $29.95 Registration Fee will be charged to ensure against 'No-Show' Registrations.

*The $29.95 Registration Fee will cover the 300+ Slide and e-Workbook. In addition, the **Certificate of Attendance.

 
Full Presentation - $495.00
Includes:

Register for the Webinar Here

Register Now
 
 Group Registration Options:
Select Multiple Seats Below:

Register Full Packet Here

Select Your Date Below:

 

New Dates:
  - - Register for June 2
  - - Register for July 7
  - - Register for August 4
   
   

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

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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