FDAnews Announces — Equipment and Process Change Control: Manage Changes Correctly and Efficiently Webinar, Dec. 9, 2015
Falls Church, VA (PRWEB) November 20, 2015 -- Equipment and Process Change Control:
Manage Changes Correctly and Efficiently
Dec. 9, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/equipmentprocesscc
Equipment and process change control is a collection of formal, documented procedures that are used to request, assess, review and formally authorize a change to process, equipment or project. Requirements for such change control are codified in federal law and FDA guidance. This fundamental topic for regulated manufacturing can be complex to the point of utter confusion,
Join FDAnews and Vadim Klyushnichenko, Ph.D. on Dec. 9 as they break it down and tell manufacturers exactly what they need to know to stay compliant. This webinar will help ensure that when changes are made to processes or equipment, nothing goes wrong.
Industry expert Vadim Klyushnichenko, Ph.D. will take attendees through the relevant sections of 21 CFR Subpart F, through a change control flow sheet, and discuss strategies for process development.
He’ll explore what process characterization is, define process parameters and help attendees determine which are critical and which aren’t.
He’ll talk about how change control applies to transitions such as going from IND to NDA, scaling up or down, or between old manufacturing technologies and new.
Finally, he’ll explore a pair of detailed case studies in change control to show attendees exactly how these principles work in the real world.
This webinar will teach attendees:
• The definitions and explanations of a change control system in the biopharmaceutical industry
• What the regulatory requirements for change control are
• What the current process development strategy in the biopharmaceutical industry is and how change control is applied to different phases of drug development and manufacturing
• How to characterize process and define critical process parameters
• What kind of technology transfer strategies are applicable for the biopharmaceutical industry
• Equipment and process qualification and validation as a final step of equipment change control
• Practical examples of equipment and process changes
Who Will Benefit:
• R&D and Analytical Scientists
• Process Development Engineers
• QA managers and personnel
• Validation specialists
• Consultants
• Quality system auditors
Meet the Instructor:
Vadim Klyushnichenko, (Ph.D.) is the President and Founder of Key Pharma Consulting, LLC. Dr. Klyushnichenko has over 15 years of experience in biopharmaceutical project management, analytical development and formulation, drug process development, engineering and scale up to pilot and manufacturing level, international tech-transfer and regulatory filing for oral, injectable, pulmonary drugs and drug/device combinations.
Webinar Details:
Equipment and Process Change Control:
Manage Changes Correctly and Efficiently
Dec. 9, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/equipmentprocesscc
Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/equipmentprocesscc
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]
Share this article