In-Depth Pharma Training in North Bethesda

Deep Dive Pharma Training Courses 

Join us as we take a deep dive into critical areas of pharmaceutical manufacturing. 

Clean in Place Fundamentals

11–12 July 2019

Clean-in-place design integration and cleaning chemical selection are vital components of every pharmaceutical manufacturing process; indeed, all pharmaceutical companies employ some type of cleaning application every day. As a result, FDA inspections of cleaning processes have been occurring with greater frequency in today's highly regulated manufacturing environment. To achieve effective and easily validated cleaning methods is to gain a thorough understanding of cleaning methods.

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.

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Instructor

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.

Instructor

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.


Pharmaceutical Water Generation

15-16 July 2019

Pharmaceutical water is perhaps the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. In addition to non-compendial systems, pharmaceutical facilities typically include systems for generating USP Purified Water (PW) and USP Water-For-Injection (WFI). This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control and laboratory water as well as key design philosophies. The course will include discussion of the upcoming European Pharmacopoeia regulatory change allowing alternative WFI production methods in addition to distillation. The change will align EP requirements closely with USP WFI production methods opening opportunities for membrane based systems. The course will also include material from the new ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam and Process Gases and will review optimizing sampling plans to significantly reduce operational costs.

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Instructor

Andrew Collentro is Technical Director for Water Consulting Specialists, an engineering and consulting firm serving the pharmaceutical and biotechnology industries. He has more than 15 years of experience in the design, commissioning, and qualification of pharmaceutical water purification systems; specializing in process design and regulatory compliance of USP Purified Water and WFI Systems. Collentro is a member of the ISPE Training Faculty, and has taught courses for PDA and other industry organizations. He is also a Chapter Leader for the ISPE Baseline® Guide for Water and Steam Systems and past Chair of the ISPE Critical Utilities Community of Practice (CoP).


Storage, Delivery and Qualification of Pharmaceutical Waters

17-18 July 2019

This classroom course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the ISPE Baseline® Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging. The course material will cover methods for determining the appropriate distribution and storage strategy, including sanitization method, for various operating circumstances including an overview of optional distribution approaches and the advantages and disadvantages of each. Microbial control characteristics of the various distribution systems will be presented and compared. Point-of-use service and sample point design, materials of construction for distribution and storage systems, and instrument components will also be covered.

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Instructor

Andrew Collentro is Technical Director for Water Consulting Specialists, an engineering and consulting firm serving the pharmaceutical and biotechnology industries. He has more than 15 years of experience in the design, commissioning, and qualification of pharmaceutical water purification systems; specializing in process design and regulatory compliance of USP Purified Water and WFI Systems. Collentro is a member of the ISPE Training Faculty, and has taught courses for PDA and other industry organizations. He is also a Chapter Leader for the ISPE Baseline® Guide for Water and Steam Systems and past Chair of the ISPE Critical Utilities Community of Practice (CoP).