Course Description:
Companies face many common issues and confusion when creating or revamping their validation programs. Some of them include:
- While an organization has ample experience in perfecting its process validation program, it may not be able to get its arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ).
- Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the customer.
- For systems that employ software and hardware, how does the company manage the validation activities, i.e. through the software validation effort or through the equipment qualification program?
The answers to these and many more typical questions and scenarios will be detailed in this training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.
Learning Objectives:
This FDA validation seminar will instruct attendees on:
- How to Define a Sustainable Structure of a Firm’s Validation Program
- Understanding How Change Control and Other Quality Programs Feed Into the Validation Program
- Analyzing Usable Protocol and Other Validation Program Document Templates
- How to Define Minimal Recommended Tests and Verifications for
- Equipment Qualification
- Process Validation
- Software Validation
- Common Pitfalls to Avoid When Executing Validation Protocols
- How to Estimate Costs and Time Associated with Validation
- How to Respond to Customer and Regulatory Audit Observations Associated with Validation
Seminar Fee Includes:
Who will benefit:
This seminar will help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program. The following job titles/ positions will benefit from attending:
- Internal Auditors
- Regulators
- Legal Department Personnel
- Compliance Officers
- Validation Managers
- QA/QC Managers
- Facilities and Engineering Department Staff
| Day One (8:30 AM – 4:30 PM) | Day Two (8:30 AM – 12:30 PM) | ||
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Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM Welcome and Introductions (15 Minutes)
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Welcome and Day 1 Reinforcement (15 Minutes)
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Meet Your Instructor
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Jonathan M. Lewis Founding Partner, Reliant FDA Experts™…a Division of Advanced Biomedical Consulting, LLC Jonathan M. Lewis, founding partner, Reliant FDA Experts™ - a division of Advanced Biomedical Consulting, LLC, has over nineteen years’ experience in the areas of quality control/quality assurance (QA/QC), regulatory affairs, manufacturing, validation, project management, and executive management in both the industry and in consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal food industries. Prior to founding Reliant FDA Experts™, Mr. Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level validation engineer to the associate director of consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/validation manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, as a sterility assurance laboratory technician. |
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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]
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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).
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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 $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.
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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.
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