Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
This course will provide a fundamental overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residues.
Chris McNulty is Director of Sales for Pharmaceutical and Biotechnology products for 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.
Rebecca Brewer has more than 29 years of experience in validation and compliance within the pharmaceutical, biopharmaceutical and medical device industries. As a consultant, Becky has had the opportunity to audit, develop and provide training in validation and compliance programs for a large variety of companies and products. Becky’s work has led to the development of procedures and policies in some of the most challenging environments, including research and development, contract manufacturers and suppliers. Becky is the current instructor for ISPE’s Cleaning Validation Educational course and PDA’s Biotechnology Cleaning Validation course. She also frequently conducts site-specific validation and GMP compliance training for individual companies.
This classroom course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses quality management and GMP inspection preparation, and provides guidance on advanced asset lifecycle management strategy.
Jack Chu has more than (30) years of business experiences in Bio-pharm and Life Sciences Industries. He is a licensed Professional Engineer. He has designed and implemented many significant projects worldwide since 1985. Jack also successfully led professional teams as an expert witness for many complicated legal cases relating to engineering, technology, and operational issues. Mr. Chu is a leading expert in OSD (Oral Solid Dose Form) process development, quality assurance, facility & equipment system design and implementation, including manufacturing and technical operations. Jack is one of the strong advocates for “PAT Implementation”, “Single-use Technology Application” and “Continuous Manufacturing Process” for Pharmaceutical and Biological Manufactures. He brings many successful engineering solutions and recommendations to the pharmaceutical industry and academic societies.
Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9, and Q10 and ASTM E2500. Topics covered include the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process; producing high-quality products and consistent operation to meet product user requirements.
Dan Franklin, CIRM, CxA is the Regional Manager of Integrated Project Services’ Midwest US Commissioning and Qualification operations based in Indianapolis, Indiana. Current responsibilities include consulting; and program planning, delivery and execution support for capital projects and risk-based verification programs. Mr. Franklin has over 30 years of project delivery and operations support experience. Graduated from Lewis University with a Bachelor of Science degree in Aviation Maintenance Management, Mr. Franklin has also earned an MBA degree from National University and a number of industry certifications & licenses. Mr. Franklin supports the ISPE Commissioning & Qualification COP as a Steering Committee Member, and has served as a contributing author to the ISPE FE Guide, the C&Q Applied Risk Management Good Practice Guide, and the ISPE Decommissioning Good Practice Guide. He is also a designated classroom training Instructor for the new ISPE course and workshop; “Risk- Based Verification of Facilities, Systems and Equipment” and for the Baseline Guide 5 course, “Commissioning and Qualification.”