Auditing and Validation Services for FDA Regulated Industry

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  • Includes Correlation to ISO 13485, ICH Q7 APIs and US Predicate Rules
  • Master GMP Boot Camp for Drug, Device, and Combination Products
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  • Group Discounts are available!
3-Day Master GMP Boot Camp - November 6th, 7th & 8th.
"From the Auditor's Perspective"
Scroll down for Course Agenda

SpringHill Suites New Orleans Downtown/Convention Center
Call 800-321-2211 (Block Rooms - GMP Boot Camp Block)

Per Seat at $1,495.00 Each Group Discount - 5 Seats at $995.00 each

 
 
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SUMMARY:

Download the Agenda Here
- GMP 101 - The Basics
- Electronic Systems and 21 CFR Part 11 Compliance
- Drug GMPs in accordance with 21 CFR Parts 210/211 and ICH Q7
- Medical Device GMPs in accordance with 21 CFR Part 820 and ISO 13485
- Combination Products GMPs (Drug/Device & Biologics/Device)
- Validation and Qualification
- The Quality Management System overview
Who Will Benefit:

Companies who:
• Develop,
• Manufacture,
• Package and/or
• Distributing

Products or Services Supporting:
• Pharmaceuticals,
• Dietary Supplements,
• Biologics,
• Medical Devices or
• Combination Products

Employees:
• Quality Assurance
• Quality Control
• Industrial/Process Engineers
• Training Managers and Coordinators
• Operations and Manufacturing
• Compliance and Regulatory Affairs
• General/Corporate Legal Counsel

Companies preparing for:
• PAI and Mock FDA Audits
• Site Remediation
• Customer/Client GMP Requirements

About the Speaker

John Cuspilich, Sr. SME GMP Auditor / Instructor
Owner - The Auditing Group, Inc. and GMP Publications and Sr. Editor for GXPNews.
John has conducted more than 1400 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. Published, co-sponsored and conducted 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. With 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.

GMP Publications
http://www.auditing.com
GXP News for the Regulated Industry Whats new with the FDA
Day 1 Course Agenda

Download the Agenda Here

- GMPs 101 – The basic overview of general GMP Concepts - a 2.5 hour full cGMP Basics overview for beginners to the most experiance of cGMP professionals. Satisfies the annual cGMP Training requirement for all employees.

- 2 Hour 21 CFR Part 11 / Annex 11 Electronic Systems – The Basic Overview - a 2 hour in-dept discussions on meeting the Federal Requirements for Electronic Systems.

  • 21 CFR Part 11 Definitions, System Types and Classifications
  • Real World Systems Considerations
  • 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
  • Protection of Systems – Passwords and Security Measures

- 21 CFR Parts 210/211 Drug GMPs (With correlations to ICH Q7) – The Basics

  • Organizational & Management Responsibilities
  • Document Control Program
  • Employee Orientation, Quality Awareness, and Job Training
  • Plant Safety and Security
  • Internal Quality/GMP Training
  • Facility Design and Layout - Basis of Design and Utilities
  • Environmental Control Program
  • Facility Maintenance and Good Housekeeping Program
  • Equipment Design, Placement, Equipment Identification, Maintenance & Cleaning
  • Measurement Equipment Calibration Program
  • Equipment Qualification Program
  • Material/Component Specification and Purchasing Control
  • Material/Component Receipt, Inspection, Sampling, Testing, Storage and Handling
  • Inventory Control Program Vendor (Supplier) Control Program
  • Material/Component/Label Verification, Storage, and Handling
Day 2 Course Agenda

- 21 CFR Parts 210/211 Drug GMPs (With correlations to ICH Q7) – The Basics (Cont.)

  • Equipment/Line/Area Cleaning, Preparation, and Clearance
  • 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
  • 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

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

  • 21 CFR Parts 820 and ISO 13483 Overview
  • 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 (CAPA)
  • Device labeling
  • Device packaging
  • Handling, Storage and Distribution
  • Installation
Day 3 Course Agenda
- 21 CFR Part 820 Medical Device GMPs (With correlations to ISO 13485) (Cont.)
  • Records - General requirements
  • Records - Device master record (DMR and what goes into the files)
  • Records - Device history record (DHR and what goes into the files)
  • Records - Quality system record
  • Records - Complaint files
  • Servicing
  • Statistical Techniques (Different systems, software and qualifications)
  • Recall and Traceability
  • Corrective and Preventive Actions (CAPA)
- Systems Validation
  • 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)
- Combination Devices – The Basics
  • Product Jurisdiction – 21 CFR Part 3
  • Regulation of Combination Products – 21 CFR Part 4: Scope
  • General Considerations for cGMP Compliance for Single Entity Products
  • 211 and 820 applicability – A Risk Based Approach
  • Streamline Approach
  • Post Marketing Requirements
  • Questions to the Agency

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