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2 Day Device (ISO 13485 / FDA 21 CFR Part 820 QSR) GMP Conference

cGMP Training from the Auditor's Perspective

20 - 21 June, 2018 - Atlantic City, New Jersey

(Looking for the Drug GMP Conference? - Click Here)


All Boot Camps Includes:

  • GMP Seminar Binders,
  • Handbooks
  • Certificates of Attendance
  • Breakfast & Lunch (both days)

$995.00 USD Per Person

 

Sheraton Atlantic City Convention Center Hotel
2 Convention Boulevard, Atlantic City, NJ 08401

www.sheratonatlanticcity.com

 

Day 1 Topics

- Breakfast and Opening Introductions

- GMP 101 The Basics

- 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)
    • (a) Validation
    • (b) Copies of records
    • (c) Protection of records
    • (d) Limiting system access
    • (e) Audit trails
    • (f) Operational system checks
    • (g) Authority checks (h) Device checks
    • (i) Education, Training, Experience
    • (j) Policies and Procedures
    • (k) Systems documentation
  • Risk Analysis - Determine Which Systems Need to be Validated
  • Steering Committee and Charters

- Lunch

- 21 CFR Part 820 Device GMPs (With correlations to QSIT and ISO 13485)

  • GMP Basics 101
  • Part 11 Overview
  • Scope and Definitions
  • Quality System Requirements
  • Management responsibility
  • Quality audit
  • Personnel
  • Design Controls
  • Document Controls
  • Purchasing Controls
  • Identification and Traceability
  • Production and process controls
  • Inspection, measuring, and test equipment
  • Process validation
  • Acceptance Activities
  • Receiving, in-process, and finished device acceptance
  • Acceptance status
  • Nonconforming product
  • Corrective and preventive action
  • Device labeling
  • Device packaging
  • Handling
  • Storage
  • Distribution
  • Installation
  • Records - General requirements
  • Records - Device master record
  • Records - Device history record
  • Records - Quality system record
  • Records - Complaint files
  • Servicing
  • Statistical Techniques


Day 2 Topics

- Breakfast

- ISO 13485:2016 (with Comparisons with ISO 13485:2003 and 21 CFR Part 820)

  • Terms and definitions
  • Quality management system
  • General requirements
  • Documentation requirements
  • Management responsibility
  • Management commitment
  • Customer focus
  • Quality policy
  • Planning
  • Responsibility, authority and communication
  • Management review
  • Resource management
  • Provision of resources
  • Human resources
  • Infrastructure
  • Work environment and contamination control
  • Product realization
  • Planning of product realization
  • Customer-related processes
  • Purchasing
  • Production and service provision
  • Control of monitoring and measuring equipment
  • Measurement, analysis and improvement General
  • Monitoring and measurement
  • Control of nonconforming product
  • Analysis of data
  • Improvement

- Lunch - Warning Letters

- Validation and Qualification

  • Definitions
  • GAMP Overview
  • Risk Analysis - Determine Which Systems Need to be Validated
  • Software / System Development Life Cycle (SDLC)
  • Compiling the Validation Master Plan (VMP)
  • Project Plan (PP) Development
  • User Requirement Specifications (URS)
  • Functional Requirement Specifications (FRS)
  • Design Specifications / Design Qualifications (DQ)
  • Installation Qualifications (IQ)
  • Operational Qualifications (OQ)
  • Performance Qualifications (PQ)
  • Auditing GxP Computer Systems
The Speaker

Mr. John F. Cuspilich, Sr. Auditor - Sr. Instructor
GMP Publications & The Auditing Group

John is the CEO of 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 30 years of 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, remediate 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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