Analytical Instrument Qualification and Validation – Understanding Use of Excel and FDA Audit Preparation


2-Day In-Person Seminar, from COMPLIANCE TRAININGS (Code – SEM9012)

Analytical Instrument Qualification and Validation – Understanding Use of Excel and FDA Audit Preparation

JOY MCELROY

Maynard Consulting Company

April 19 – 20, 2018

Raleigh, NC, USA

 

Why You Should AttendAgendaSpeakerPricingVenue
In this two day workshop conference you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors.

The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility? This seminar will help attendees understand the instrument qualification and system validation processes and will provide instruction on how to prepare for FDA audits and how to become part 11 compliant.


Seminar Fee Includes:
Training
Lunch
AM-PM Tea/Coffee
Seminar Materials
USB with Presentation Handout
Attendance Certificate
Networking Sessions
$100 Gift Voucher for next seminar

Areas Covered :

  • Learn about the regulatory background and requirements for laboratory instrument qualification and system validation
  • Understand the logic and principles of instrument qualification and system validation from validation planning reporting
  • Understand and be able to explain your company’s qualification and validation strategies
  • Be able to independently prepare and execute test protocols, this includes setting specifications and acceptance criteria
  • Understand how to review and approve qualification and validation protocols
  • Understand Validation and Use of Excel in the QC Laboratory
  • Learn about Handling raw data and other laboratory records
  • Be able to develop inspection ready qualification and validation deliverables
  • Learn how to avoid and/or respond to FDA inspectional observations and warning letters

Who Should Attend :

This seminar will be beneficial personnel in pharmaceutical development and quality control laboratories and contract testing laboratories as well as Individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment and processes. Following personnel will benefit from the course:

  • Laboratory managers, supervisors and analysts
  • IT managers and staff
  • Consultants
  • Laboratory suppliers of material, equipment and services
  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Validation engineers
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Quality engineers
  • Quality auditors

DAY 1 (9 AM – 6 PM):

Registration Process – (9:00 AM – 9:30 AM)

Lecture 1 –

  • Requirements and approaches for Analytical Instrument Qualification
  • Going through the qualification phases

Lecture 2 –

  • Testing and deviation handling
  • Retrospective qualification and Requalification

Lecture 3 –

  • Equipment Maintenance and Change control
  • Type and extend of qualification for USP Instrument Categories

Lecture 4 –

  • Requirements and approaches for Laboratory Computer Systems
  • Examples for risk assessment of computer systems

DAY 2 (9 AM – 6 PM):

 

Lecture 5 –

  • Validation of Laboratory Computer systems
  • Preparing inspection ready validation documentation

Lecture 6 –

  • Validation and Use of Excel in the QC Laboratory
  • How to ensure spreadsheet and data integrity

Lecture 7 –

  • Periodic review and revalidation of chromatographic data system
  • Handling raw data and other laboratory records
  • Ensuring Integrity and Security of Laboratory (Raw) data

Lecture 8 –

  • Auditing Laboratory Computer Systems and records for FDA Compliance
  • Learn how to avoid or respond to FDA 483s and warning letters
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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 – $ 1400 (Save $ 200 on Early Bird Discount)
Regular Price – $ 1600

Group of 3 Delegates – Get 10% Discount (Save $ 1020)
Group of 5 Delegates – Get 20% Discount (Save $ 2400)

EARLY BIRD OFFERS CLOSES ON MARCH 20, 2018
 
 
 
 
Early bird seats are limited and based on first-come, first-serve..(Only 5 Remaining)
 

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

 
REGISTER NOW


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
    5969, 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.

Raleigh, NC, USA

(Venue to be announced shortly)
April 19 – 20, 2018
  

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

  

REGISTER NOW