Auditing and Validation Services for FDA Regulated Industry

Tel: 609-526-3464 - info@gmpbootcamps.com

 

 

 

 P FDA.COM Information PortalAud

8-hour cGMP Boot Camp 102 focuses on;
- The cGMP Basics 101
- Part 11 Electronic Records; Electronic Signatures
- The Auditor's Basics
- The QMS Requirements
Includes:
- - Binders (shipped free for US Customers)
- - Handbooks
- - Certificate of Attendance (Completion)

Next Available Dates:

 

- - August 27, 2020

 

- - September 28, 2020

 

- - October 26, 2020

Taught by Auditing SMEs 'From the Auditor's Perspective'

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Course Agenda

GMP QMS 101 The Basics - The required GMP Training for all employees who operate under Title 21 Compliance Requirements.

  • GMP - What is cGMP and the GMP Lifestyle?
  • The Agency History and Objectives
  • Roles and Responsibilities
  • The 10 Principals of GMP
  • Good Documentation Practices (GDocP)
  • Facility Management
  • The History of GMP, the Agency Inspections and 483s
  • Warning Letter Reviews

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
    • Steering Committee and Part 11 Initiatives

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
- - Non-Conformance
- - Change Control
- - Deviations
- - Out of Specifications / Out of Trend
- - Complaints
- - Recalls
- - Product Traceability
- - Audit - Internal, Agency, Customers and External Audit
- - Vendors, Suppliers, Contractors and Consultants
- - Basic Risk Management
- - Training Program

Questions and Answers


Presenter / Auditor
Mr. John F. Cuspilich, Sr. Instructor
CEO of GMP Publications - The Auditing Group and The Validation Group

John is the CEO and Senior Auditor for The Auditing Group, Inc. (www.auditing.com).

John also serves as the Senior Editor at GMP Publications, Inc. and the CEO of The Validation Group.

John has conducted more than 1200 GxP audits, Gap Analysis and remediation projects world-wide, with over 35 years, hands-on technical and management level experience within the Pharmaceutical, Biotechnology, Medical Device, Petrochemical, Validation, and regulated industries.

John has conducted hundreds of speaking engagements, seminars and bootcamp style training seminars world-wide.

Published, cosponsored and audit reviews of thousands of technical and professional papers, journals and books for hundreds of Companies in the regulated industry.

John has assisted hundreds of companies in meeting and exceeding regulatory compliance, pertaining to ‘for-cause’ or ‘due-diligence’ initiatives. Assisting companies to achieve, resolve, remediation and exceed regulated industry requirements, mandates, ‘for-cause’ and ‘due-diligence’ priorities with the technique of promoting GxP standards and practices through interactive hands-on training.

John has extensive knowledge in industry standards; FDA (CDER, CBER, CDRH, CVM, CFSAN), cGMP, GLP, ICH, OECD, GAMP, ISO, OECD, OSHA, HACCP, HIPPA, EPA and GCP regulations and thorough knowledge in the process of implementation of these standards.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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