FDA and EU Process Validation and Equipment Qualification


2-Day In-Person Seminar, from COMPLIANCE TRAININGS (Code – SEM9059)

FDA and EU Process Validation and Equipment Qualification


   


      Joy McElroy

    New Jersey, NJ, USA

 


    April 25 – 26, 2019

1 DELEGATE

3 DELEGATES

5 DELEGATES

$ 1200

(Save $ 300) 🛈

$ 1080 / Delegate

(Save $ 1260) 🛈

$ 960 / Delegate

(Save $ 2700) 🛈

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Seminar DescriptionAgendaSpeakerPricingVenue

The FDA’s Quality System Regulation (QSR) is clear on the importance of equipment controls – you must have and follow procedures for installing, operating and maintaining all equipment used in your manufacturing processes. And that includes any ancillary equipment that affects production, such as environmental systems and contamination controls.

This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.

Who Should Attend:

Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.

  • Quality Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • Engineering Departments
  • Manufacturing Departments
  • Production Departments
  • Operations Departments
  • Validation Teams
  • Design Engineers
  • Process Owners
  • Internal Auditors

Why Should you Attend:

Participants will gain:

  • An understanding of what the global expectations are for equipment qualification and validation
  • An understanding of the documents required for equipment qualification and process validation and how to manage documents appropriately
  • Understand and know how to write and maintain a Validation Master Plan
  • Better writing and execution skills for sound protocols for equipment qualification (IQ, OQ, PQ) and process validation
  • Ability to qualify already existing systems more effectively and efficiently and to execute requalification’s more effectively
  • Ability to collect data, conduct tests, and obtain all necessary documents
  • An understanding of the different types of validation
  • An understanding of performance validation
  • Knowledge of the guidelines on validating analytical methods and processes
  • Ability to support equipment qualification and validation through the quality management system, risk analysis, calibration and maintenance, and change control
  • An understanding and knowledge of the principles of auditing the equipment qualification and validation
  • An understanding of external qualifications and validations from a contract manufacturer, and qualifications and validations by a supplier
  • Ability to investigate true root causes of problems and to evaluate and prioritize solutions
  • Ability to develop effective problem solving methods to help you asses which is best for your situation
  • Ability to develop successful implementation plans
  • Ability to perform risk assessments effectively

Areas Covered:

Regulatory Requirements and Expectations for Equipment Qualification

  • Europe
  • FDA
    • Global harmonization and expectations
    • Management of Documents, Documents Required
  • Validation policy
    • Validation Master Plan (VMP)
    • Documents equipment qualification
    • SOPs
    • Responsibilities
    • Validation team
  • Presumption for qualification/validation

General Aspects of Qualification

  • Qualification phases, DQ, IQ, OQ, PQ
  • Qualification of existing systems and equipment
  • Requalification/validation

Performance Qualification and Process Validation

  • SOPs
  • Writing a qualification protocol, content
  • Executing a qualification
  • Tests and data
  • Documents
  • Writing a qualification final report

DAY 1 (8.30 AM – 4.30 PM):

Registration Process – (8.30 AM – 9:00 AM)

Regulatory Requirements and Expectations for Equipment Qualification
– Europe
– FDA
– Global harmonization and expectations
– Management of Documents, Documents Required

Validation policy
– Validation Master Plan (VMP)
– Documents equipment qualification
– SOPs
– Responsibilities
– Validation team

General Aspects of Qualification

Qualification phases, DQ, IQ, OQ, PQ
– Design Qualification
– Installation Qualification
– Operational Qualification
– Process Qualification
– Performance Qualification

Questions / Comments / Discussion

DAY 2 (8.30 AM – 4.30 PM):

 

Operational Qualification of existing systems and equipment
– Requalification/validation

Performance Qualification and Process Validation

Writing SOPs
– Writing a qualification protocol, content

Executing a qualification

Tests and data

Documents and writing a qualification report

Final Questions / Comments / Discussion


Joy McElroy

Co-Owner of Maynard Consulting Company


 

Joy McElroy offers 14 years of experience as a consultant and over 20 years’ total experience in the pharmaceutical and biotech industries in quality control, clinical settings, good manufacturing practice (GMP) auditing as well as validation engineering. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, GMP and good laboratory practice training. She has written and executed equipment qualification and validation protocols for numerous companies. Joy is co-owner of Maynard Consulting Company.

PRICING OPTIONS
For Single Delegate – $ 1200 (Save $ 300 on Early Bird Discount)
Regular Price – $ 1500

Get 10% Discount on Group of 3 Delegates – $ 1080 / Delegate on Early Bird Offer (Save $ 1260)
Get 20% Discount on Group of 5 Delegates – $ 960 / Delegate on Early Bird Offer (Save $ 2700)

EARLY BIRD OFFERS CLOSES ON   APRIL 11, 2019
 
 
 
 
Early bird seats are limited and based on first-come, first-serve.
 

For discounts on multiple registrations, contact customer care at +1-416-915-4458

 
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Payment Options

Register Online:

  • Make Secure Payment using Credit Card
  • Click on Register Now, and you will be redirected to Payment Options page.
  • Please choose your option (No. of delegates) from the drop down and click on Add to basket
  • Click on Proceed to Checkout on the Cart Page, and complete the registration.
  • Once the payment is completed, you will be receiving a Form to fill up the Delegates Information
  • An electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date.
  • Please bring the respective passes to the event venue.


Pay by Wire:

  • Please contact our support to assist you with registration by Wire
  • Support Number: +1-416-915-4458
  • E-mail: info@webinarcompliance.com

By Check:

  • Pay your check to (payee name) “FutureCorp Consulting Inc” our parent company
  • Please send the Scanned copy of the check to info@webinarcompliance.com
  • Mail the check to:
    FutureCorp Consulting Inc
    5939, Candlebrook Ct.,
    Mississauga, ON L5V 2V5,
    Canada
  • Once we receive the check, you will be receiving a Form to fill up the Delegates Information
  • After payment receipt, from the registered attendee, an electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date. Please bring the respective passes to the event venue.
 

Hilton Newark Airport

Newark, NJ, USA | April 25 – 26, 2019


Call for Assistance: +1-416-915-4458   Register Now