Tuesday, April 5, 2016
Location: Baxalta Inc
1 Baxter Way Westlake Village, CA 91362
Rebecca Brewer, Strategic Practice Lead, Quality Executive Partners
Chris McNulty, Director of Pharmaceutical/Biotech Sales, Sani-Matic Inc.
ISPE LA January 20, 2016 program addressed “Cleaning Agent Selection and Implementing a New Cleaning Approach”. This program will be follow-on to address challenges and correct approaches after your facility has decided to move forward with improved cleaning processes. Learn about Cleaning Enforcement and Observations, Best Practices and Design for CIP, CIP Technologies and Cleaning Validation.
Topics to be Covered:
• Cleaning Validation Limits – Overview of the new industry guidance on cleaning validation limits and practical tips on incorporating the new limits into existing programs
• CIP Technologies – Examination of the current state of the art for CIP design and management
• Sampling Methods and Limitations – Taking a fresh look at what the limitations are for swab and rinse sampling along with lessons learned on recovery studies
• Spray Device Technologies – Overview of spray device technologies and spray device limitations when integrating them into CIP processes
• Cleaning Validation Considerations for Automated Equipment – Points to consider when validating cleaning processes for automated equipment; the considerations begin from the equipment qualification and carry through to the process validation
• Integrating CIP into a Process – Examination of the challenges of integrating CIP into various processes and ensuring and effective cleaning program
• Cleaning Agent Selection, Product / Process Grouping, and Scale-Up Studies – Consideration of Quality by Design elements from the outset of cleaning agent selection, product and process grouping through scale-up and eventual validation
About the Presenters:
Rebecca Brewer, Strategic Practice Lead, Quality Executive Partners Becky is the course instructor for the ISPE Cleaning Fundamentals class, and co-instructor with Chris McNulty for the ISPE Clean-In-Place course. Becky also teaches the PDA course on Cleaning Validation for Biotechnology. As Strategic Practice Lead for Quality Executive Partners, Becky works with customers to develop sustainable, compliant cleaning validation programs across a wide variety of manufacturing environments, including Biotech, traditional pharma, API production, medical device and in vitro diagnostics. Becky has more than 28 years in the industry. Becky previously had worked for Dober Chemical Corporation, Raytheon Engineers & Constructors and Bristol-Myers Squibb.
Chris McNulty, Director of Pharmaceutical/Biotech Sales, Sani-Matic Inc. Chris is an instructor for the ISPE Clean-In-Place course and has co-instructed with Becky Brewer on numerous occasions. He is responsible for leading Sani-Matic’s sales team and their customers through the complex BioPharm regulatory landscape and generating detailed system cleaning approaches to meet industry standards and customer-specific processes. He is driven by the desire to “solve problems for our customers and ensure they meet regulatory requirements. His experience spans more than 30 years including field commissioning and program development while also serving as an electrical project engineer and technical services manager.