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2 Day Drug and Dietary Supplement GMP Conference

'cGMP Training from the Auditor's Perspective'

18 - 19 June, 2018 Atlantic City, New Jersey

(Looking for the Medical Device - FDA/ISO13485 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 (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
  • The Predicate Rules - Basics
  • Attitudes and Behavior Patterns
  • 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
Day 2 Topics

- Breakfast

- 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
  • Distribution Controls
  • Marketing Controls
  • 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

- Complaint Handling and Customer Satisfaction Program

- cGMP for Sterile Drug

- ICH Q9 Quality Risk Management

- ICH Q10 Pharmaceutical Quality System

- cGMP for Phase 1 Clinical

- Questions and Answers

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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