2-Day In-Person Seminar (Code – SEM9047)
Analytical Instrument Qualification and Validation – Understanding Use of Excel and FDA Audit Preparation
Joy McElroy
Richmond, VA, USA
February 21 – 22, 2019
1 DELEGATE |
3 DELEGATES |
5 DELEGATES |
(Save $ 300) FEBRUARY 5, 2019 Regular Price: $ 1500 (Save $ 1260) Get 10% Discount on Early Bird Offer (Save $ 2700) Get 20% Discount on Early Bird Offer |
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.
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
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.
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 FEBRUARY 5, 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
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.
Courtyard by Marriott Richmond Airport
Richmond, VA, USA | February 21 – 22, 2019