Auditing and Validation Services for FDA Regulated Industry

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

 
   

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All Boot Camps Conferences Includes:
  • GMP Seminar Binders
  • Handbooks
  • Certificates of Attendance
  • Lunch and Refreshments

$995.00 USD Each - Sign-up Today!

Courtyard by Marriott Atlantic City
1212 Pacific Ave
Atlantic City, NJ 08401

2 Day Drug cGMP Boot Camp
21 CFR Part 211 Drug GMPs / ICH Q7 API

 


 

2 Day Medical Device Boot Camp
US FDA Part 820 / ISO 13485 & Validation

5 - 6 November, 2018
Atlantic City, New Jersey

'From the Auditor's Perspective'

$995 for 2 Days

8 - 9 November, 2018
Atlantic City, New Jersey

'From the Auditor's Perspective'

$995 for 2 Days

Drug GMP - Day 1 Topics Medical Device - Day 1 Topics

- Breakfast and Opening Introductions

- GMP 101 The Basics (Satisfies the annual GMP Training Requirements)

- 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 Parts 210/211 Drug GMPs -
(with ICH Q7 - API Correlations)

  • GMPs - The Basics - Quality Definitions, CAPA, Deviations, Non-Conformance
  • Organizational & Management Responsibilities
  • Document Control Program
  • Employee Orientation, Quality Awareness, and Job Training
  • Plant Safety and Security
  • Internal Quality/GMP Training Session Program
  • Quality Cost Program
  • Design Control
  • Facility Design and Layout
  • Environmental Control Program
  • Facility Maintenance and Good
  • Housekeeping Program
  • Outside Contractor Control Program
  • Equipment Design and Placement
  • Equipment Identification
  • Equipment Maintenance & Cleaning
  • Measurement Equipment Calibration Program
  • Equipment Qualification Program
  • Material/Component Specification and Purchasing Control
  • Material/Component Receipt, Inspection, Sampling, and Laboratory Testing
  • Material Component Storage and Handling
  • Inventory Control Program Vendor (Supplier) Control Program
  • Material/Component/Label Verification, Storage, and Handling
  • Equipment/Line/Area Cleaning, Preparation, and Clearance
  • Operational Process Validation and Production Change Order Control


- 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 ISO 13485)

  • 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


Drug GMP - Day 2 Topics Medical Device - Day 2 Topics

- 21 CFR Parts 210/211 Drug GMPs (Cont.)

  • In-Process Inspection, Sampling, and Laboratory Control
  • Reprocessing/Disposition of Materials
  • Finished Product Verification, Storage, and Handling
  • Finished Product Inspection, Sampling, Testing, and Release for Distribution
  • Complaint Handling and Customer Satisfaction Program
  • Operational Process Validation and Production Change Order Control
  • In-Process Inspection, Sampling, and Laboratory Control
  • Reprocessing/Disposition of Materials
  • Finished Product Verification, Storage, and Handling
  • Finished Product Inspection, Sampling, Testing, and Release for Distribution
  • Distribution Controls
  • Marketing Controls

- Lunch

- Recall and Traceability

- cGMP for Sterile Drug

- ICH Q7 FAQ

- ICH Q9 Quality Risk Management

- ICH Q10 Pharmaceutical Quality System

- cGMP for Phase 1 Clinical

- Process Validation

- Questions and Answers

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

  • Definitions
  • Quality Management System
    • Quality Manual
    • Medical Device File
    • Control of Documents
    • Control of Records
  • Management Responsibilities
    • Management Commitments
    • Quality Policy
    • Planning
    • Responsibilities, Authority and Communications
    • Management Review
  • Resourse Management
    • Provision of Resources
    • Human Resources
    • Infrastructure
    • Work Environment and Contamination Control
  • Product Realization
    • Planning of Product Realization
    • Customer Related Processes
    • Design and Development
    • Purchasing
    • Production and Service Provision
    • Control of Monitoring and Measuring Equipment
  • Measurement, Analysis and Improvement
    • Monitoring and Measurement
    • Control of Non-Conforming Product
    • Analysis of Data
    • Improvements

- Lunch

- Validation and Qualification (Electronic Systems)

  • 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
Presenter / Auditor

Mr. John F. Cuspilich, Sr. Instructor
CEO of GMP Publications - The Auditing Group and The Validation 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, hands-on technical and management level experience within the Pharmaceutical, Biotechnology, Medical Device, Petrochemical, Validation, and regulated industries.

Over the past 30 years, 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.

 

 

 

Training Boot Camp Seminars: - Mix and Match - Customize your own training!

 
  • Enhance and supplement your training requirements
 
  • Expand your understanding of the GMP Life Style Concepts
 
  • Understand your roles and responsibilities within your industry
   
 

There are many reasons to advance your training requirements, now, learn from the experts at GMP Boot Camps. Taught by the experts in the field, boots on the ground, hands-in real-world experience.
Learn from the professionals.

   
 

The Mission…
To help companies, organizations and individuals successfully manage, control and continuously improve performance by integrating GMP initiatives of productivity, quality, health and safety, and to ensure regulatory compliance into a proactive “Lifestyle” concept.

The Commitment…
To help make compliance and performance the personal responsibility and shared commitment of individuals working in the Food, Drug, Medical Device, Cosmetic and Healthcare Industries.

 

 


 

 

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