Course Description:

Validation of laboratory systems, manufacturing facilities, manufacturing equipment, computer systems and analytical test methods may be nice to have in some businesses, but is an essential regulatory requirement for regulated companies.

This workshop is designed to give attendees basic training in the principles and practices of validation, using your own systems as examples in our workshops of what to do, what not to do and how to document validation for inspection.

In this two day workshop conference:

  • You will learn the different global agencies expectations of validation for pharmaceutical manufacturers or contract organizations supporting GMP/GLP/GCP operations
  • We will focus primarily on drugs and devices, and will tailor the course to the specific needs of the attendees using case studies from both our own and attendees experience (within limits of confidentiality)
  • You will earn the underlying regulations and the current industry practices for risk-based validation, with take-away lessons and learning you can apply to be more efficient and effective back on the job
  • We will make available workshop materials including templates for various types of validations, and complete several in-session using real-life working examples
  • We will facilitate both public and private review sessions where confidentiality must be maintained
  • Upon registration attendees will receive some advance conference materials to gather information to use in their own workshop and private sessions.

Learning Objectives:

Upon completing this course participants should:

  • Know the domestic and foreign regulations requiring validation
  • Understand the principles of validation
  • Be able to design a risk-based validation plan which can significantly reduce validation effort and documentation
  • Understand the relationship between specifications and verifications
  • Know which validation documents are critical for inspection
  • Design a validation plan and qualification protocols for their own systems
  • Be able to effectively present validation documentation for inspection

Who will Benefit:

This course is designed for people responsible for the validation of equipment, facilities, computer systems and test methods used in GMP facilities. This includes the end users, scientists, chemists, engineers, quality assurance and system administrators working in drug, device, pharmaceutical companies, as well as their counterparts in contract research, contract manufacturing and contract analytical testing organizations.

Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Quality Control chemists

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

Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  1. Attendees goals for the conference
    1. setting priorities
    2. Areas of emphasis for conference and workshop
  2. Regulations requiring validation
    1. FDA
    2. EMA, EU
    3. EPA
    4. ICH
  3. Principles of Validation
    1. The V-Model
    2. Traceability
    3. Validation documentation
    4. Specifications
    5. URS, FRS, SDS
    6. Qualifications
    7. IQ, OQ, PQ, UAT
  4. Workshop
  5. Computer Systems Validation
    1. Enterprise applications
    2. LIMS
    3. Electronic Document Management
    4. Clinical data systems
    5. Manufacturing controls
    6. Environmental monitoring
    7. Case studies
  6. Workshop
  1. Facility Qualification and Validation
    1. Relationship of commissioning, qualification and validation
    2. ISPE guidance
    3. Case studies
  2. Risk-based equipment qualification and validation
    1. Use of vendor documentation vs. custom scripting
  3. Analytical test method validation
    1. Data acquisition and LIMS integration
  4. Workshop

Meet Your Instructor

Dr. Richard Poser
President, First Quality Inc.

Dr. Richard Poser has been both receiving and conducting audits in drug, laboratory, device, software and manufacturing environments for over 25 years and teaches from personal experience. He has been Director of Laboratories in both R&D, clinical phase and commercial operations in drugs and medical devices, and has been a consulting quality systems advisor or auditor to dozens of diagnostic, biologics, pharmaceutical and medical device manufacturers including many of the Fortune 500. Following many inspections he has been retained to design remediation and corrective actions to attain regulatory compliance. Dr. Poser is President and Lead Auditor for First Quality Inc., a consulting firm which has conducted hundreds of 3 rd -Party audits for laboratories, data systems and manufacturing operations. He has special expertise in data systems and 21CFR Part 11 compliance, and has worked with dozens of companies to validate systems used in regulated laboratories.

Register Now

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Seminar One Registration

October 8-9, 2015, San Diego, CA

$10,194.00 (23%)*

Save $2,395.00

Special Group Discount Register for Six attendees

October 8-9, 2015, San Diego, CA
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left

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Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

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After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

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Media Partners


Media Partner Benefits
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  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
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  • 10% discount to media partner's subscribers.

Media Partner To Do
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  • Announcement article of the conference on the magazine and/or website.
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  • Article on the magazine and/or website after the conference.

Local Attractions

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In Spanish, La Jolla means "the jewel," an apt name for a pretty, Mediterranean-style seaside town - sitting on cliffs flanking the ocean.
La Jolla visitors like to shop and eat in the nice restaurants, some of them with lovely ocean views. There's a lot for the active visitor, too, including ocean kayaking, tide pool-hopping, surfing at Windansea Beach, biking or running along the waterfront.

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