St. Petersburg Conference on Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach

2015-12-03 - 2015-12-04
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Course "Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are: • Company has expertise in its process validation program but can never quite get is 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? Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program. Why should you attend? Attend this FDA validation seminar to get deep knowledge about: • How to define a Sustainable Structure of a Firm's Validation Program • Understand How Change Control and Other Quality Programs Feed Into the Validation Program • Offer Usable Protocol and Other Validation Program Document Templates • Define Minimal Recommended Tests and Verifications for o Equipment Qualification o Process Validation o 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 Areas Covered in the Session: • Basics Of Validation • The Components of a Sustainable Validation Program • Other Programs that Feed the Validation Program (1 Hour) • Equipment, Utility, and Facility Qualification • Process Validation • Software Validation • Time and Costs of Validation • Responding to Validation and Other Related Audit Findings Who will benefit: • Internal Auditors • Regulators • Legal Departments • Compliance Officers • Validation Managers • QC Managers • QA Managers • Facilities and Engineering Department Staff Agenda: Day 1 Schedule: Lecture 1: Understanding the Basics of Validation • Regulatory References • Validation Terminology Lecture 2: The Components of a Sustainable Validation Program • Design Qualification • FATs and SATs • Commissioning • The Validation Master Plan • The Validation Project Plan • Standard Operating Procedures (SOPs) • Protocols • Reports • Additional Software Validation Documents Lecture 3: Other Programs that Feed the Validation Program • Change Control • Complaint Handling • CAPAs • Deviation Management • Maintenance • Sales Lecture 4: Equipment, Utility, and Facility Qualification • The SOP • Protocol Template • Minimal Testing and Verifications for IOQ • Minimal Testing and Verifications for PQ • Facility Qualification • Execution of Protocols • Report Generation Lecture 5: Process Validation • The SOP • Protocol Template • Minimal Testing and Verifications • Execution of Protocols • Report Generation Lecture 6: Software Validation • The SOP • Protocol Template • Additional Software Validation Document Templates • Minimal Testing and Verifications • Execution of Protocols • Report Generation Lecture 7: Time and Costs Associated with Validation • Estimating Time Associated with Each "Deliverable" • Hidden Costs of Validation • Estimating Costs of Using Validation Consultants • How to Recoup Costs Associated with Validation for Contract Manufacturers Lecture 8: Responding to Audit Findings Associated with Validation Day 2 Schedule: Lecture 9: Welcome and Day 1 Reinforcement Lecture 10: Practical Application # 1 -Equipment Qualification Lecture 11: Practical Application # 2 -483 Responses Lecture 12: Closing Comments Individual/Open Q&A Session Speaker: Jonathan M. Lewis Principal, Advanced Biomedical Consulting (ABC), LLC Jonathan M. Lewis Founding Partner, Reliant FDA Experts��...a Division of Advanced Biomedical Consulting, LLC, has over twenty-three years' experience in the areas of quality control/quality assurance (QA/QC), regulatory affairs, manufacturing, validation, project management, and executive management in both industry and 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 an Associate xDirector 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, in Sterility Assurance. Location: St. Petersburg, FL Date: December 3rd & 4th, 2015 Time: 9 AM to 6 PM Venue: Courtyard St. Petersburg Downtown Address: 300 4th St N, St Petersburg, FL 33701, United States Price: $1,295.00 (Seminar for One Delegate) Register now and save $200. Until November 15, Early Bird Price: $1,295.00 From November 16 to December 01, Regular Price: $1,495.00 Registration Details: NetZealous LLC - DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone: 1-800-447-9407 Fax: 302-288-6884 Registration Link -

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