Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
This classroom course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits, providing tools to manage all project resources. It is specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project management in the regulated pharmaceutical environment. Trends in regulatory compliance, environmental, health and safety legislation, project delivery methodologies and product speed to market expectations all impact how pharmaceutical facility projects are managed.
William Deckert is the Business Area Leader for OPM (Owner's Project Manager) Services for CAI (Commissioning Agents Inc.) an employee owned consulting firm specializing in helping clients complete their projects in a more timely manner and get their new products to market quicker. He has over 30 years of design/build experience with clean compliant research and manufacturing facilities worldwide. He has managed engineering and construction projects from concept all the way through to validation, with project sizes up to $500mm.
This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry.
Cheryl Bondurant, a Compliance Consultant at CAI is a professional with 38 years of experience working in FDA and ISO regulated environments. She has implemented effective compliant quality systems for medical devices, biologics, in-vitro diagnostics and electronics. Cheryl is an instructor of FDA regulations and ISO standards and implementation for Quality Systems for Medical Devices and Current Good Manufacturing Practices for Finished Pharmaceuticals.
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.
Rebecca Brewer has more than 29 years of experience in validation and compliance within the pharmaceutical, biopharmaceutical and medical device industries. 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.
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.