Course Description:

Companies face many common issues and confusion when creating or revamping their validation programs. Some of them include:

  • While an organization has ample experience in perfecting its process validation program, it may not be able to get its arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ).
  • Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the customer.
  • For systems that employ software and hardware, how does the company manage the validation activities, i.e. through the software validation effort or through the equipment qualification program?

The answers to these and many more typical questions and scenarios will be detailed in this training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.

Learning Objectives:

This FDA validation seminar will instruct attendees on:

  • How to Define a Sustainable Structure of a Firm’s Validation Program
  • Understanding How Change Control and Other Quality Programs Feed Into the Validation Program
  • Analyzing Usable Protocol and Other Validation Program Document Templates
  • How to Define Minimal Recommended Tests and Verifications for
    • Equipment Qualification
    • Process Validation
    • Software Validation
  • Common Pitfalls to Avoid When Executing Validation Protocols
  • How to Estimate Costs and Time Associated with Validation
  • How to Respond to Customer and Regulatory Audit Observations Associated with Validation

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will benefit:

This seminar will help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program. The following job titles/ positions will benefit from attending:

  • Internal Auditors
  • Regulators
  • Legal Department Personnel
  • Compliance Officers
  • Validation Managers
  • QA/QC Managers
  • Facilities and Engineering Department Staff

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 12:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Welcome and Introductions (15 Minutes)

  1. Understanding the Basics Of Validation (45 Minutes)
    • Regulatory References
    • Validation Terminology
  2. The Components of a Sustainable Validation Program (30 Minutes)
    • Design Qualification
    • FATs and SATs
    • Commissioning
    • The Validation Master Plan
    • The Validation Project Plan
    • Standard Operating Procedures (SOPs)
    • Protocols
    • Reports
    • Additional Software Validation Documents
  3. Other Programs that Feed the Validation Program (1 Hour)
    • Change Control
    • Complaint Handling
    • CAPAs
    • Deviation Management
    • Maintenance
    • Sales
  4. Equipment, Utility, and Facility Qualification (1 Hour)
    • The SOP
    • Protocol Template
    • Minimal Testing and Verifications for IOQ
    • Minimal Testing and Verifications for PQ
    • Facility Qualification
    • Execution of Protocols
    • Report Generation
  5. Process Validation (1 Hour)
    • The SOP
    • Protocol Template
    • Minimal Testing and Verifications
    • Execution of Protocols
    • Report Generation
  6. Software Validation (1 Hour)
    • The SOP
    • Protocol Template
    • Additional Software Validation Document Templates
    • Minimal Testing and Verifications
    • Execution of Protocols
    • Report Generation
  7. Time and Costs Associated with Validation (1 Hour)
    • Estimating Time Associated with Each Deliverable
    • Hidden Costs of Validation
    • Estimating Costs of Using Validation Consultants
    • How to Recoup Costs Associated with Validation for Contract Manufacturers
  8. Responding to Audit Findings Associated with Validation (1 Hour)
  9. Day 1 Closing Comments and Questions (30 Minutes)

Welcome and Day 1 Reinforcement (15 Minutes)

  1. Practical Application # 1 – Equipment Qualification (1.5 Hours)
  2. Practical Application # 2 – 483 Response (1.5 Hours)
  3. Closing Comments (15 Minutes)
  4. Individual/Open Q&A Session (30 Minutes)

Meet Your Instructor

Jonathan M. Lewis
Founding Partner, Reliant FDA Experts™…a Division of Advanced Biomedical Consulting, LLC

Jonathan M. Lewis, founding partner, Reliant FDA Experts™ - a division of Advanced Biomedical Consulting, LLC, has over nineteen years’ experience in the areas of quality control/quality assurance (QA/QC), regulatory affairs, manufacturing, validation, project management, and executive management in both the industry and in consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal food industries.

Prior to founding Reliant FDA Experts™, Mr. Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level validation engineer to the associate director of consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/validation manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, as a sterility assurance laboratory technician.

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