This two day course provides the fundamental knowledge needed to comply with the FDA's cGMP QSR, ISO, and International Medical Device Regulators Forum (IMDRF) (formerly GHTF) requirements for process validation and offers practical advice on how to develop and implement an efficient and effective validation program.
Attendees will learn what, when, why, and how to conduct process validation in compliance with FDA and international agency regulations. Additional topics covered in the course include how to develop pragmatic protocols, maintaining satisfactory validation documentation, how to define and perform the IQ/OQ/PQ validation sequence, analysis of trending data, and evaluating the need for re-validation.
Learning Objectives:
- Understand when and why validation is required
- Become familiar with regulatory requirements, industry practice, and associated guidance documents relevant to process validation
- Understand the consequences of not validating or doing it poorly
- Define the components of a good validation strategy
- Application of problem solving methods to help asses which strategy is best in various situations
- Develop successful validation master plans
- Define requirements for validation documentation
- Write a comprehensive protocol
- Common statistics for sound results
- Executing the IQ/OQ/PQ validation sequence
- Establish ongoing process monitoring and control requirements
- Evaluate when revalidation is needed
Who will Benefit:
This course is designed for people tasked with ensuring compliance to FDA’s Medical Device Quality System Validation requirements. Following personnel will benefit from the course:
- Quality professionals
- Compliance professionals
- Production supervisors
- Auditors
- Manufacturing engineers
- Design/development engineers
- Process owners
- Quality engineers
- Registration Process: 8:30 AM – 9:00 AM
- What is Validation?
- Validation vs. Verification
- Types of Validation
- History and Recent Trends
- Why Validate?
- Economic Reasons
- Consequences of Not Validating – 483 and Warning Letter Examples
- Regulatory Requirements and Expectations
- Quality System Regulation 21 CFR 820
- Industry Guidance Documents
- Global Harmonization and Expectations
- Definitions and Terminology
- FDA vs. GHTF
- Key Term Glossary
- When to Validate
- Processes Requiring Validation
- Validation Decision Tree
- Processes NOT Requiring Validation
- Validation Planning
- Validation Timing
- Prospective Validation
- Defining Your Strategy
- Establishing the Process Validation Program
- Validation Trade Offs
- Validation Process Flow Overview
- Risk Management as a critical tool
- Validation Documentation
- Process Validation Master Plan (PVMP)
- Protocol
- Analysis Techniques
- Policies and procedures
- Validation Timing
- Validation Sequence
- Installation Qualification (IQ)
- Agency Definitions and Key Components
- Conducting IQ
- Operational Qualification (OQ)
- Considerations and Key Components
- Measurement and Sources of Variation
- Experimental Design
- Sample Sizes
- Statistical Process Control
- Process Capability
- Performance Qualification (PQ)
- Considerations
- Summarizing and Reporting Data
- Ongoing Process Monitoring
- Revalidation
- How to Handle Validation Failures
- Installation Qualification (IQ)
- Case Studies
- Validation Strategy and Planning
- Specific Elements of the Protocols
- Process Monitoring and Controls
- Initial Monitoring
- Ongoing Controls
- Revalidation
- When to Revalidate
- Rationale for NOT revalidating
- Case Studies
- Validation Strategy and Planning
- Specific Elements of the Protocols
- Questions
Anne Holland
Founder and CEO, QA Consulting Inc.
Anne Holland combines more than 25 years of biomedical engineering and quality assurance experience with business acumen as founder and CEO of QA Consulting, Inc., an Austin, TX, based firm founded in 2000. Anne is skilled in every phase of quality assurance from design concept and R&D through manufacturing/ production, and post-market surveillance of medical devices. She specifically focuses on design controls, internal and supplier audits, risk management, process validation, and 483/ Warning Letter remediation.
Ms. Holland received a B.S. in Biomedical Engineering from Vanderbilt University in Nashville, TN, and an MBA from the University of Colorado in Denver, CO. She holds certifications as an ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ASQ Certified Manager of Quality/ Organizational Excellence (CQM), Exemplar Global Quality Management System Lead Auditor, and Society of Quality Assurance Registered Quality Assurance Professional in Good Laboratory Practices.
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to Register for the Seminar/Conference/Event
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
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 $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) 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.
In the event ComplianceOnline cancels the seminar, ComplianceOnline 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.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
- Logo on name cards
- Logo placement on the podium
- Logo on the lanyards for all speakers
- Exclusive stall at the entrance
- A full page brochure advert
- Moving banner ad on the website
- Logo on promotional email campaign
- Logo on name cards
- A half page brochure advert
- Exclusive stall at the entrance
- A quarter page brochure advert
- Moving banner ad on the website
- Logo on name cards
- Logo placement on the podium
- Logo on the lanyards for all speakers
- Exclusive stall at the entrance
- A full page brochure advert
- Moving banner ad on the website
- Logo on promotional email campaign
- Logo on name cards
- A half page brochure advert
- Exclusive stall at the entrance
- A quarter page brochure advert
If you wish to partner with us for this event please contact us: [email protected] or call us: +1-888-717-2436.
- Logo on name cards
- Logo placement on the podium
- Logo on the lanyards for all speakers
- Exclusive stall at the entrance
- A full page brochure advert
- Logo on promotional email campaign
- Logo on name cards
- A half page brochure advert
- Exclusive stall at the entrance
- A quarter page brochure advert
- Moving banner ad on the website
- Logo on name cards
- Logo placement on the podium
- Logo on the lanyards for all speakers
- Exclusive stall at the entrance
- A full page brochure advert
- Moving banner ad on the website
- Logo on promotional email campaign
- Logo on name cards
- A half page brochure advert
- Exclusive stall at the entrance
- A quarter page brochure advert
- Moving banner ad on the website
If you wish to sponsor this event please contact Cruise Webster: [email protected] or call us: (207) 576-4173
Local Attractions of Boston, MA
Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
North End
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.
Old North Church
The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.