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2-day In-person Seminar

Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach


December 3rd & 4th, 2015

Time: 9:00 AM to 6:00 PM

St. Petersburg, FL

Venue: Courtyard St. Petersburg Downtown


Director : Jonathan M. Lewis
  Price: $1,295.00
(Seminar Fee for One Delegate)
Register now and save $200. (Early Bird)
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    • Until November 15, Early Bird Price: $1,295.00 From November 16 to December 01, Regular Price: $1,495.00


**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

Course "Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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

  • Company has expertise in its process validation program but can never quite get is 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?
    Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.

Why should you attend:

Attend this FDA validation seminar to get deep knowledge about:

  • How to define a Sustainable Structure of a Firm's Validation Program
  • Understand How Change Control and Other Quality Programs Feed Into the Validation Program
  • Offer Usable Protocol and Other Validation Program Document Templates
  • 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

Areas Covered in the Session:

  • Basics Of Validation
  • The Components of a Sustainable Validation Program
  • Other Programs that Feed the Validation Program (1 Hour)
  • Equipment, Utility, and Facility Qualification
  • Process Validation
  • Software Validation
  • Time and Costs of Validation
  • Responding to Validation and Other Related Audit Findings

Who Will Benefit:

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

Day 1 Schedule


Lecture 1:

Understanding the Basics Of Validation

  • Regulatory References
  • Validation Terminology

Lecture 2:

The Components of a Sustainable Validation Program

  • Design Qualification
  • FATs and SATs
  • Commissioning
  • The Validation Master Plan
  • The Validation Project Plan
  • Standard Operating Procedures (SOPs)
  • Protocols
  • Reports
  • Additional Software Validation Documents

Lecture 3:

Other Programs that Feed the Validation Program

  • Change Control
  • Complaint Handling
  • CAPAs
  • Deviation Management
  • Maintenance
  • Sales

Lecture 4:

Equipment, Utility, and Facility Qualification

  • The SOP
  • Protocol Template
  • Minimal Testing and Verifications for IOQ
  • Minimal Testing and Verifications for PQ
  • Facility Qualification
  • Execution of Protocols
  • Report Generation

Lecture 5:

Process Validation

  • The SOP
  • Protocol Template
  • Minimal Testing and Verifications
  • Execution of Protocols
  • Report Generation

Lecture 6:

Software Validation

  • The SOP
  • Protocol Template
  • Additional Software Validation Document Templates
  • Minimal Testing and Verifications
  • Execution of Protocols
  • Report Generation

Lecture 7:

Time and Costs Associated with Validation

  • 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

Lecture 8:

Responding to Audit Findings Associated with Validation

Day 2 Schedule


Lecture 9:

Welcome and Day 1 Reinforcement


Lecture 10:

Practical Application # 1 -Equipment Qualification


Lecture 11:

Practical Application # 2 -483 Response


Lecture 12:

Closing Comments


Individual/Open Q&A Session

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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

Jonathan M. Lewis

Principal, Advanced Biomedical Consulting (ABC), LLC

Jonathan M. Lewis Founding Partner, Reliant FDA Experts®...a Division of Advanced Biomedical Consulting, LLC, has over twenty-three years' experience in the areas of quality control/quality assurance (QA/QC), regulatory affairs, manufacturing, validation, project management, and executive management in both industry and 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 an 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, in Sterility Assurance.

Location: St. Petersburg, FL Hotel: Courtyard St. Petersburg Downtown   300 4th St N, St Petersburg, FL 33701, United States

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