2019 ISPE North Bethesda November In-Depth Pharma Training Series

Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.

  • Real World Practice:  Courses present exercises that use current problems and situations common to the industry.
  • Experienced Instructors:  Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
  • Global Training to Fit Your Needs:  With classroom, eLearning and onsite training options available, ISPE training courses adapt to any schedule or location.   

Join us as we take a deep dive into critical areas of pharmaceutical manufacturing at the ISPE Bethesda Training Facility located at 6110 Executive Blvd, Suite 600, North Bethesda, MD 20852.


Applying the Biopharmacetical Manufacturing Facilities Baseline Guide Principle

5-6 November 2019

Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products. The course includes a review of biopharmaceutical manufacturing facility design and regulatory issues important in the US and Europe that involve industry trends and changing regulatory policy. Participants will discuss current case studies on a wide array of facility topics, and complete class exercises that involve developing facility scope of work and deliverables to meet corporate economic goals and regulatory requirements.

Registration Coming Soon

Instructor

Robert Warn is a Senior project manager and Principal Engineer at Commissioning Agents Inc., with over 14 years in the biotechnology industry. He has extensive project management, process engineering, commissioning, qualification and process validation experience on biotechnology manufacturing systems and equipment. His expertise are focused on process tech-transfer and manufacturing equipment implementation. As well, Robert has consulted on implementing PPQ and C&Q programs for his clients. Robert has a mechanical engineering background and is a current member of the ASME Bioprocessing Equipment (BPE) Standards Committee.


An Overview of Biopharmaceutical Manufacturing Processes

7-8 November 2019

This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion and adsorptive chromatography.

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Instructor

Rusty Morrison is an experienced pharmaceutical professional with over 30 consecutive years of experience at all levels in technology transfer, CMC project management, process validation, commissioning, qualification, validation, engineering, and manufacturing. Significant biopharmaceutical experience includes managing a bulk drug substance site-to-site tech transfer; managing early-stage RNA interference CMC activities for multiple products in the development pipeline; multiple assignments managing teams providing risk-based validation, commissioning, and engineering services for mammalian cell culture facilities; and serving as Director of Facilities & Engineering for a startup vaccine manufacturer. Other relevant experience includes leadership of a team responsible for all process validation protocols for the start of commercial operations at one of the largest mammalian cell culture facilities in the U.S.; including protocol generation, execution, deviation resolution, and report preparation.


Pharmaceutical Water Generation ( North America)

11-12 November 2019

This classroom course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation. Participants will examine methods for proper water quality selection, information on compendial and non-compendial waters, fundamentals of basic water chemistry, and information on common unit operations (deionization, reverse osmosis, and distillation). Pre-treatment systems, detailed guidance for selection of construction materials, and operations issues related to pharmaceutical water generation systems will also be discussed.

Registration Coming Soon

Instructor

Gary V. Zoccolante is the Technical Director of Plymouth Rock Water Consultants. He was formerly Pharmaceutical Technical Director for Evoqua Water Technologies. Zoccolante has over 40 years of experience in the design, operation and trouble-shooting of pharmaceutical water systems. He has been involved in the development of equipment for pretreatment, reverse osmosis, deionization, ultrafiltration and distillation. Zoccolante, a member of ISPE since 1992 was a committee member of both the original and updated ISPE Baseline® Water and Steam Systems Guide. He has been part of the Guide Presentation Team on several occasions. He was involved in face-to-face meetings with FDA to help resolve many of the Guide principles. Zoccolante is a member of the ISPE Critical Utilities Community of Practice Steering Committee. He has worked on the development of the ISPE “Good Practice Guide - - Commissioning and Qualification of Pharmaceutical Water and Steam Systems”. He was selected to deliver the first public presentation of the Guide. Zoccolante developed the four-day ISPE Pharmaceutical Water course and has presented the course to hundreds of pharmaceutical industry personnel including FDA personnel.


Storage, Delivery and Qualification of Pharmaceutical Waters (North America)

13-14 November 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.

Registration Coming Soon

Instructor

Gary V. Zoccolante is the Technical Director of Plymouth Rock Water Consultants. He was formerly Pharmaceutical Technical Director for Evoqua Water Technologies. Zoccolante has over 40 years of experience in the design, operation and trouble-shooting of pharmaceutical water systems. He has been involved in the development of equipment for pretreatment, reverse osmosis, deionization, ultrafiltration and distillation. Zoccolante, a member of ISPE since 1992 was a committee member of both the original and updated ISPE Baseline® Water and Steam Systems Guide. He has been part of the Guide Presentation Team on several occasions. He was involved in face-to-face meetings with FDA to help resolve many of the Guide principles. Zoccolante is a member of the ISPE Critical Utilities Community of Practice Steering Committee. He has worked on the development of the ISPE “Good Practice Guide - - Commissioning and Qualification of Pharmaceutical Water and Steam Systems”. He was selected to deliver the first public presentation of the Guide. Zoccolante developed the four-day ISPE Pharmaceutical Water course and has presented the course to hundreds of pharmaceutical industry personnel including FDA personnel.


A Risk-based Approach to GxP Process Control Systems:  Applying the GAMP Good Practice Guide:  A Risk-based Approach to GxP Process Control Systems

20-21 November 2019

This highly interactive classroom course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course covers recommended good practice based on a lifecycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP 5 may be practically applied to process control systems. The course covers both regulated company and supplier quality management systems and the full system life cycle from concept to retirement.

Registration Coming Soon

Instructor

Mike Byrd, the Director of Computer System Validation (CSV) for ProPharma Group</b> has over 25 years in the pharmaceutical and biotechnology industries, and over 30 years of information systems experience. Mike’s educational credentials include a Bachelor of Science in Chemistry and a Master’s in Business Administration with an emphasis in Technology Management. Mike has developed, implemented, administered, and validated a wide variety of computer-based solutions supporting critical regulated business processes. These included systems supporting automation and control on the shop floor; laboratory automation, data acquisition, and information management; quality workflow management; manufacturing execution; distribution; shipping; enterprise resource planning, interfaces for cross-system integration and IT infrastructure supporting a diverse technical computing environment. He has held numerous individual contributor and management roles in his career, many of which have involved forming and managing cross-functional system project teams.


Sterile Product Manufacturing Facilities:  Applying the ISPE Baseline Guide and FDA Guidance Principles to Design and Operation (T12) 

18-19 November 2019

This classroom course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities. Using the referenced documents, this course will cover regulatory philosophy, aseptic process and equipment considerations, aseptic clean room design and operation, differential pressure requirements, airlocks, air filtration, HVAC design considerations, and a brief introduction to barrier isolation technology. In addition, the course will include an exercise in the layout of an aseptic filling facility. In many cases, when a new facility is required within an existing or new building, the designer will begin by sketching a floor plan. This exercise will demonstrate how to use process flow diagrams and an accommodation schedule to thoroughly define facility requirements before advancing to the floor plan layout stage.

Registration Coming Soon

Instructor

Christa Myers is a Senior Pharmaceutical Engineering Specialist at CRB with more than 20 years of experience providing clients with insight as to how innovative technologies apply to process and facility designs. Her involvement starts with the strategic concept and continues through construction and startup of projects. Building on her years as an operator, Christa has used her first-hand approach and understanding to assist her clients in designing facilities and equipment – each facility being unique, with different drivers, different products and different dosing mechanisms. With 20+ years of operating and designing filling equipment experience, Christa has been instrumental in many fill finish projects—both retrofits and new construction. With an extensive background in the design of fill-finish facilities, chemical kilo labs, pilot plants, API research and manufacturing facilities, bulk pharmaceutical chemical facilities, highly hazardous compound containment, and biotech process facilities, Christa’s broad range of expertise benefits her clients in the design of their facilities.