2-days workshop on
Equipment Qualification and Validation of Processes
Date: Thursday, 13 September 2018 - Friday, 14 September 2018 | Location: Raleigh-Durham, NC, USA | Download Workshop Brochure
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.

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
Who will Benefit
  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Validation engineers
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Process owners
  • Quality engineers
OnlineCompliancePanel
Agenda

Day One:(8:30 a.m - 4:30 p.m)

(8:30 a.m. - 9:00 a.m.: Registration and Breakfast)

Speaker and Participant Introductions(9:00 a.m. - 9:15 a.m.)

Regulatory Requirements and Expectations for Equipment Qualification(9:15a.m. - 9:45a.m.)
  • Europe
  • FDA
  • Global harmonization and expectations
  • Management of Documents, Documents Required
Validation policy(9:45a.m. - 10:30a.m.)
  • Validation Master Plan (VMP)
  • Documents equipment qualification
  • SOPs
  • Responsibilities
  • Validation team
Break/networking(10:30a.m. - 10:45a.m.)

General Aspects of Qualification(10:45a.m. - 11:00a.m.)
Qualification phases, DQ, IQ, OQ, PQ(11:00 a.m. - 12:00 p.m.)

Lunch and networking(12:00p.m. - 1:00p.m.)

Design Qualification (1:00 p.m. - 1:30 p.m.)
Installation Qualification(1:30 p.m. - 2:00 p.m.)
Operational Qualification(2:00 p.m. - 2:30 p.m.)
Process Qualification(2:30p.m. - 3:00p.m.)

Break/networking(3:00p.m. - 3:15p.m.)

Performance Qualification(3:15p.m. - 4:15p.m.)
Final questions/ Comments/Discussion(4:15p.m. - 4:30p.m.)

Day Two:(8:30 a.m - 4:30 p.m)

(8:30 a.m. - 9:00 a.m.: Networking and Breakfast)

Operational Qualificationof existing systems and equipment(9:00a.m. - 10:00a.m.)
  • Requalification/validation
(10:00a.m. - 10:15a.m.)Break/networking

Performance Qualification and Process Validation(10:15a.m. - 11:15a.m.)


(11:15a.m. - 12:0p.m.)
  • Writing SOPs
  • Writing a qualification protocol, content
(12:00p.m.- 1:00p.m.)Lunch/networking

Executing a qualification(1:00p.m. - 2:00p.m.)
Tests and data(2:00p.m. - 3:00p.m.)

(3:00pm - 3:15pm)Break and networking

Documents and writing a qualification report(3:15p.m. - 4:15p.m.)
Final questions/Comments/Discussion(4:15p.m. - 4:30p.m.)












Joy McElroy - Principle Consultant, Maynard Consulting Company


Upon earning a degree in Zoology from North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.

Price/Register

Register yourself for this brainstorming session Now . You can do single registration or group or register via P.O/Check or Wire.

Register Online
Single Registration
Regular Price : $1,550.00
Special Price : $1,200.00
save $350.00 on Early Bird Discount
Special Group Discount
$1,080/attendee - Register for 2 attendees and get additional 10% discount
save $940 on Early Bird Discount
$960/attendee - Register for 3 - 5 attendees and get additional 20% discount
save $1770 on Early Bird Discount
$840/attendee - Register for 5 + attendees and get additional 30% discount
save $3550 on Early Bird Discount
Early Bird Discount ends 2 weeks before scheduled event
Your registration fee includes the workshop, all course materials and lunch.
Register by P.O. / Check / Wire Transfer
Excited to join the workshop on "Equipment Qualification and Validation of Processes" then register for the same by P.O. / Check / Wire Transfer. Call us Toll Free at (510)-857-5896 for any registration related assistance.

If you are Paying by Check:
Checks should be payable to Holkoi LLC and mailed to:
38780 Tyson Lane Suite 210 Fremont
California 94536, USA

Wire Transfer:
If you wish to pay by wire transfer. Call us toll free on 510-857-5896
Note
If you have a group of more than five people or If you plan on registering a corporate team, please feel free to contact our customer support team at (510)-857-5896 or send an email to customersupport@onlinecompliancepanel.com for a special discount.
Need Help!
In case you find difficulty in registering, availing the discount or need further information regarding the workshop, please feel free to contact our customer support team at (510)-857-5896 or send an email to customersupport@onlinecompliancepanel.com. We will help you.
Terms & Conditions to Register for the Workshop
Your registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for the workshop call us at (510)-857-5896 or email us at customersupport@onlinecompliancepanel.com

Payment Process
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to HOLKOI LLC. (our parent company)

If you are paying by check, the check should be payable to HOLKOI LLC and mailed to: 38780 Tyson Lane Suite 210 Fremont California 94536
The registration fee includes: The workshop; all related course materials; tea/coffee and lunch on both the days

Cancellations and Substitutions
For online registration, use your American Express, Visa or MasterCard.

In case you find difficulty in registering, call us at (510)-857-5896 or sent an email to customersupport@onlinecompliancepanel.com. We will help you to register hassle-free.

Any cancellation request received at least 10 calendar days prior to the start date of the event will receive a refund with a $200 administration fee deduction. No cancellations will be accepted - nor refunds issued - within 10 calendar days from the start date of the event.

On request (before the commencement of the workshop) a credit for the amount paid minus administration fees ($200) will be transferred to any future Online Compliance Panel event and a credit note will be issued. Substitutions may be made at any time.

Onsite registrations are also possible. However we accept only credit card payments and check payments. Conference material will be issued on the spot depending on the availability. In case it is not available we will send the material by post after the conference is over. In the event, Online Compliance Panel cancels the workshop; the company is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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Documents to Carry
Online Compliance Panel will issue an electronic event pass to each registered candidate once the registration is confirmed. Please bring the pass to the venue of the event.
Location:

Raleigh-Durham, NC, USA

Venue/Hotel:

DoubleTree by Hilton Hotel Raleigh-Durham,

4810 Page Creek Ln, Durham,

NC 27703, USA