ispe

New Jersey ISPE Lunch and Learn Brochure All Seminars listed in this Brochure have been reviewed for their Educational Content by the NJISPE Education Committee for Content Table of Contents 1. Design Construction 2. HVAC 3. Water 4. Air 5. Clean Rooms 6. Washers & Sterilizers 7. PAT 8. Controls 9. Commissioning and Validation

NJISPE Lunch and Learn Seminar Brochure The New Jersey chapter of The ISPE Education Committee is developing a Lunch and Learn Seminar Brochure. The purpose of the Brochure is to offer our ISPE members a list of educational seminars that can be selected for in-house educational programs. To be considered for the Brochure, Vendors must first submit their entire proposed seminar, including a detailed abstract, to the NJISPE Education Committee for review. The NJISPE Education Committee will review the seminars and abstracts. Those with educational content will be added to the Brochure. (Company promotional presentations and sales presentations are not considered for this listing). An abstract for each seminar accepted for the listing, along with contact information, will be added to the brochure. Upon completion, the Seminar Brochure will be distributed electronically to all Chapter Members as an educational programming resource. Additionally, the brochure will also be posted on the Chapter website.

Vendor Seminar Requirements: 1. Vendors are to submit an abstract and PowerPoint presentation of their proposed seminar to the Education Committee for review. A New Jersey Chapter Board Member will review the seminar for it educational content. Vendors may submit as many seminars as they would like. 2. Upon acceptance, the submitter will provide contact information for the Seminar Brochure listing and agree to present the seminars as reviewed. Additional content/information can be added to the end of the seminar; however, the seminar must be presented as reviewed. Changes to the seminar must be re-submitted to the Education Committee for review. 3. The Chapter will distribute only the abstract and contact information for arranging a seminar. Companies interested in the “Lunch and Learn” presentation will contact the seminar provider directly for an appointment. 4. Distribution of the presentation will be exclusively by the submitter. The Education Committee retains only a record copy of the presentation and the application submission. 5. The Seminar Brochure will be updated quarterly. For additional details or to add your seminar to the Lunch and Learn Brochure, contact the Education Committee Chair, John Postiglione at [email protected].

Design Construction

Seminar Title: Modular Facility Technology Company information: Pharmadule Abstract: Modularization has become an ubiquitous term and concept within the pharmaceutical industry. This seminar is designed to add clarity to the different types of modular approaches for new facility construction, as well as renovation. Particularly the concept of modular facility will be focused on. Attendees will learn about the technical, logistical, performance (schedule and cost) aspects of the concept, as well as lessons learned. Case study examples will be provided. Who should attend: This program is designed for project managers, system engineers, and senior managers involved with new facility or renovation projects. Attendees will benefit from learning about this new technology and when to engage and/or pursue facility modularization on a project. Seminars run about 45-60 minutes, more depending on question. Contact: Gordon Leichter, 585-329-0497 , [email protected]

Design Considerations for Mounting Equipment on Roofs TCPI Increasingly stringent regulatory and manufacturing requirements frequently require more and larger equipment to be mounted on a facility roof. Design issues surrounding these changes can have structural impacts beyond the immediate area of work. This seminar looks at design considerations for adding roof-mounted equipment in light of the provisions of the 2003 International Building Code now adopted by many states. Parameters that can increase gravity loads (eg., dead load and snow) and lateral loads (eg., wind and seismic) on the building are explored. Practical solutions that can mitigate some of the issues are examined. Contact: Bob Ranard (609) 216-3866 [email protected] Facility Design Strategies for Aseptic Manufacturing Integrated Project Services This session will focus on current US and EU regulations, cGMP zoning and transitions, scope of manufacturing operations, manufacturing technology & capacities, isolation v traditional and finishes.

Contact: Scott Hickok IPS, 610-828-4090 [email protected]

Emergency Power Generation - Technologies and Regulations Foley Power Systems (Caterpillar Electric Power Generation Dealer) Abstract: A new era has begun in emergency and continuous electric power generation. Power generation products such as generators and uninterruptible power supplies (UPS) are being radically impacted by market drivers such as regulatory compliance, 24/7 uptime, power dense equipment loads, and demands for best in class technology from single source suppliers. EPA regulatory mandates (beginning in 2006) on emissions are fostering innovation in cleaner diesel engine technology. ACERTTM combustion emissions reduction technology already meets or exceeds the EPA New Source Performance Standards (NSPS) Tiers 1-3 requirements through 2010. ACERTTM has resulted from a $1 billion multiyear R&D investment in improved diesel fuel injection, air breathing, and electronic controls. The recent introduction of the C175 3-4 MW emergency diesel generators is a response to the need to backup modern power dense equipment such as servers that are pushing the upper limits of emergency diesel generators. In addition to emergency power, applications also exist for prime and continuous power. Combined heating and power (CHP) is an application with the simultaneous and sequential use of power and heat from the same fuel source. Natural gas generators and fuel cells used in CHP are demonstrating advances in efficiency (fuel burn and waste heat recapture >80% efficiency) with the benefit of very low emissions and rapid ROI. Hence, NJ Clean Air Program is currently offering financial incentives for investment in CHP. UPS are needed in an emergency power lineup to provide ride-through power to critical loads until the generator comes on line (typically <10 seconds). Based on an EPRI study of 24 utilities, 98% of power outages last less than 1 minute. Battery free UPS utilizing flywheel kinetic energy storage coupled with a static switch is a highly reliable link to a generator providing ride-through power for the seconds required to bring an emergency generator on line. Flywheel UPS technology provides 97% energy efficiency (93% battery UPS) and eliminates life cycle costs related to battery replacement and maintenance required in traditional battery based UPS. Single source suppliers that provide best in class electric generators, fuel cells, UPS, automatic transfer switches, paralleling switchgear and related products and services offer enhanced value to end-users. Contact: Scott Yappen - Pharmaceutical Segment Manager - tel 732-885-3040 - email [email protected]

HVAC

How to Establish a Commissioning and Validation Plan for HVAC and Building Automation Systems Facility Diagnostics, Inc. Abstract: Industry practices relating to the validation of HVAC and Building Automation Systems (BAS) vary widely with many users now assuming all HVAC equipment and controls serving a GMP or GLP area must be validated. This approach brings a host of unintended consequences, many of which actually add to the business and regulatory risk. In this session we will focus on developing a common sense methodology to determine which HVAC issues impact product quality. We also explain how to formulate a validation plan that balances commissioning and qualification activities while minimizing regulatory risk. In this session participants will learn- 1. Why validating the entire HVAC system is not always a good thing. 2. How to do an HVAC system and BAS impact assessment and segregate critical from non-critical components. 3. How to insure equipment is properly commissioned and how commissioning results can be integrated into the validation process to avoid duplication. 4. How to establish what must be validated, and to what extent. Contact: Ken Kolkebeck, 201-874-8700, [email protected] Accreditation: CBCP (Certified Building Commissioning Professional)

Specifying Controls for HVAC Systems; BAS, PLC, or DCS Facility Diagnostics, Inc. Abstract: HVAC equipment for GMP areas has traditionally been controlled with Building Automation Systems (BAS) which were primarily designed for comfort control applications. Many companies are using industrial and process control systems for HVAC including Programmable Logic Controllers (PLC) and Distributed Control Systems (DCS). How do you choose which is appropriate for a specific application? The session will address the following common questions- 1. Can BAS systems be validated? 2. When does a PLC or DCS based control system make sense? 3. How does the control system architecture impact that difficulty of validation, project cost, and cost of ownership? 4. What regulatory requirements for HVAC controls need to be addressed in the User Requirement Specification (URS). 5. Who should prepare the Functional Requirement Specification; system supplier, HVAC designer, or owner?

Contact: Ken Kolkebeck, 201-874-8700, [email protected] Accreditation: CBCP (Certified Building Commissioning Professional)

Water

Introduction to the Mechanics and Chemistries of Water Purification MECO Inc. Anyone in the pharmaceutical industry that uses purified water should have a good understanding of how it is purified. To understand water purification systems you need to know the contaminates you hope to remove and the technologies used to remove them. The presentation will review; the four main types of contaminates, the units and methods used to measure them. The mechanics and chemistry of the various technologies will be explained. It will include; multimedia, carbon, softeners, depth and screen filter, reverse osmosis, electro-deionization, ion-exchange, ultra filtration, ultraviolet light and distillation. Contact: John Postiglione Meco Inc 908-575-2141 Accreditation: AIA 1 ceu

[email protected]

Water System Design Planning MECO Inc. Abstract: Designing a water system is made easier when it is broken down into its separate components. This AIA Accredited seminar will start with a needs assessment, we will work through the design of a water system and review the component selection. A case studies will be used to demonstrate the selection process. Needs Assessment Usage Matrix Loop Layout and Design System Design Overview Component Selection Documentation lnstallation and Start-up Contact: John Postiglione Meco Inc 908-575-2141 Accreditation: AIA 1 ceu

[email protected]

Pharmaceutical Water Technologies MarCor Purification Abstract: This series of three Lunch-&-Learn Seminars provide a broad but technical overview of water treatment technologies employed to produce and maintain High Purity Water for Pharmaceutical and Biotech operations. Part 1 Addresses cGMP's and Regulatory Issues, Water Standards, and Measurement Technologies employed to assure compliance. Part 2 explores the technologies and processes employed to produce and maintain USP Purified Water. Part 3 addresses the technologies used to produce WFI (water for injection), and further discusses water distribution systems.

Contact: Brian White - 484-991-1200 - [email protected]

Pharmaceutical Water System Technologies Mar Cor Purification (formerly Biolab Equipment, Marcor Services & Minntech FTG, consolidated Feb.2005) Abstract: This seminar has been developed to meet the needs of engineering and technical staff responsible for the design, construction, validation or maintenance of high purity water systems. The materials provide a broad overview of all aspects of pharmaceutical water systems and the equipment used in those systems. The content is structured to accommodate either a Half-day Seminar or Three-part Lunch-n-Learn. Part 1 discusses Water Standards, Measurement Systems, and GMP Design Considerations. Part 2 addresses USP Purfied Water Systems and the technologies employed to generate and maintain Purified Water including RO, Ion Exchange, UV and Ozone. Part 3 explores WFI Systems with a review of various distillation technologies and a more in-depth discussion of various storage and distribution system philosophies. The presenter has over 15-years experience workng with all aspects of water system design, construction and commissioning, and has been involved with the installation of water systems throughout North America for virtually every major pharmaceutical company. Contact: Brian White 484-991-1200 [email protected]

Design of USP and Reagent Grade Water Systems Company information: Hydro Service and Supplies, Inc. Abstract: USP Water Systems: The US Pharmacopoeia (USP) is the official compendium of standards and specifications for pharmaceutical products and ingredients. The USP establishes specifications for two grades of bulk ingredient water – purified water and water for injection. This course examines the USP monographs for compendial water and investigates the cGMP guidelines applicable to the design of USP water systems. In addition, the course examines applicable water treatment technologies and common water system process designs. Reagent Grade Water Systems: The course defines reagent grade water and explores typical applications for this grade of water. The course examines reagent grade water specifications established by the American Society for Testing and Materials (ASTM) and the National Committee for Clinical Laboratory Standards (NCCLS). Reagent grade water systems generally consist of a number of treatment methods integrated together to achieve the water quality objectives. The course examines treat

Contact: Wes Robins 301-984-9006 [email protected] Accreditation: 1 to 2 PDH credits toward the continuing education requirements for PE's

Design of USP Water Systems Company information: Hydro Service and Supplies, Inc. Abstract: The US Pharmacopoeia (USP) is the official compendium of standards and specifications for pharmaceutical products and ingredients. The USP establishes specifications for two grades of bulk ingredient water – purified water and water for injection. This course examines the USP monographs for compendial water and investigates the cGMP guidelines applicable to the design of USP water systems. In addition, the course examines applicable water treatment technologies and common water system process designs.

Contact: Wes Robins 301-984-9006 [email protected] 1 to 2 PDH credits towards continuing education requirements for registered PE's

Air

Air Filtration & LCC Camfil Farr Inc Abstract: I submitted two seminars, one on LCC (life cycle cost) and one on fine fiber filters v coarse fiber filters. LCC On average, 75% of the LCC of air filters is ENERGY, newly developed software allows the user to optimize the best selection and combination of ASHARE grade filters to make significant savings in energy consumption. Fine fiber filters v coarse fiber filters (Glass v Synthetic) Specifying the correct media used in air filters is key to achieving ‘real life’ efficiency performance during the filters lifetime. Contact: Sean O’Reilly 973-9418820 [email protected]

LCC of Air Filters Company information- Camfil Farr Camfil Farr is the largest air filtration company in the world. We have devloped software which demonstrates that substantial savings can be made by using this unique tool for selecting filters for ahu's and Hepa filters. Energy cost historically has basically been ignored when selecting air filters. Selecting air filters on a 'TCO' (Total Cost of Ownership) basis allows the end user and engineering community to select the very best combination of filters to optimize lifetime, reduce energy, no.of changes and disposal.

Contact: Sean O'[email protected]

Humidity Measurement Basics Testo, Inc. Abstract: This seminar has been developed to assist the critical HVAC/R technician, facilities management team, and process control technicians with a basic understanding of humidity, it's various forms, units of measure, and measuring instrumentation (both fixed and portable) useful in determining humidity levels. Topics covered include: Basic definitions, Psychrometric chart design and reading, "relative" humidity, temperature dew point, calibration techniques, and critical HVAC/R concepts for clean room and environmental control

Contact: Robert A. Bove'

Testo, Inc.

973-252-1720

[email protected]

Cleanrooms

Holistic Training of Cleanroom Service Workers Company information This paper discusses the format, content and direct benefits of a new course, which has been developed specifically for the purpose of training cleanroom service workers in controlled environment facilities and technology. The program has been designed to train personnel in controlled environment operations in an applications oriented manner. The material is presented in a form, which may be understood by non-engineers and scientists. Most importantly, the course treats the subject of controlled environments in a “holistic” sense. It begins with a discussion of the nature of contamination and moves through an analysis of the facilities and operating procedures used to control it. The basic tenet of the approach lies in the philosophy of the “cleanroom as an extended system”. In this way of thinking, all aspects of the controlled environment, from the room and the people in it, to the facilities surrounding it, and even to the outside contractor or suppliers of equipment and materials, are considered to be linked and vital to the purpose of the cleanroom.

Contact: Larry DeShane

Washers & Sterilizers

GMP Washers & Sterilizers Belimed, Infection Control Abstract: Participants in this presentation will receive a thorough overview on the types of construction and features associated with GMP washers and sterilizers. Important topics that will be addressed include; door types, mounting, barriers, mechanical equipment, and control systems related to each specific piece of equipment. Also, facility considerations will be discussed which participants will learn ties directly into creating the appropriate equipment specification for the end user. Commonly accepted practices of an FAT will be discussed along with vendor and buyer expectations that promote a smooth equipment transfer to the end user. The presentation will also touch on installation issues that should eliminate any unneccessary downtime from occurring in your facility. An open discussion will follow. Contact: Mark Compo - 215 230-7725 - [email protected] Accreditation: AIA - pending.

PAT

Process Analytical Technology Case Studies Spectroscopic Solutions, LLC Abstract: This talk will describe several case studies of the use of Near IR spectroscopy and process analytical technology (PAT) in pharmaceutical manufacturing. The case studies include raw material identification, moisture quantification, and at line process control. The case studies will illustrate the importance of multivariate statistics and chemometrics in the deployment of PAT systems. Instrument qualification and method validation issues will also be discussed.

Contact: Frederick H. Long, Ph.D. , 973-229-2661, [email protected]

Controls

Process Controls & Automation 101 Integrated Controls Group (ICG) Abstract: There are a number of new engineers and existing engineers in the Pharma/Biotech industries that are new to Process Controls and Automation. This seminar will begin with the hardware basics: Analog and Discrete Inputs and Outputs, Controllers, HMIs, VFDs, and Field Devices. We will then discuss Process instruments such as Differential Pressure, Temperature, and Humidity. Project Lifecycles for Automation, Validation, GAMP, and PAT will be issues that will be touched on lightly and not in great depth. Their importance in our industry and their relevance to certain types of projects will be explored. Finally, Building Automation Systems (BAS) will be discussed as they relate to cGMP and Non-cGMP spaces. Their Architecture, When do you validate a system, when don't you? Contact: David Lonza 908.675.0323 [email protected] Accreditation: AIA - pending.

Enterprise to Control System Integration – An Introduction to the ISA S95 Standard Automated Control Concepts, Inc., 3535 Route 66, Neptune, NJ Over the past decade, most businesses have made significant investments in ERP systems and manufacturing automation. Connecting these real-time production systems to the business systems has become a key strategy for many manufacturers who are trying to maximize the return on their IT and automation investments. Integration of business systems to manufacturing can be difficult; often involving different teams with different cultures, systems, terminologies, objectives and criteria for success. The ISA S-95 standard was developed in order to help bridge this gap. The goal of the S-95 standard is to reduce the risk, cost, and errors associated with implementing the integration of enterprise systems and manufacturing operations systems. The S-95 standard accomplishes this by providing terminology and a consistent set of concepts and models for defining manufacturing operations management activities and the exchange of information between manufacturing activities and business systems. Contact: Michael Blechman 732-922-6611, x110 [email protected] Accreditation: ACC is a voting and founding member of the ISA S-95 Committee and has implemented a number of manufacturing systems with connectivity to enterprise applications.

Commissioning and Validation

Error Reduction: The Human Factors Omission Errors Talsico International 1. Human Factor Errors and System Design Errors 2. Why the ‘train and punish’ model doesn’t work 3. Categorizing Human Errors: • Learning Gap Errors, Memory Gap Errors, Inconsistency Errors, Application Errors, Omission Errors, Decision Making Errors 4. Omission Errors omissions in forms & paperwork, omissions in procedure, Attention Activation what is it and why it is the leading cause of Omission Errors, How fields and document layouts can be used to avoid omission errors, Role of color, symbols, shapes, words in Attention Activation, Using triggers and focusing aids to prevent omission errors, Analyzing & designing documents for effectiveness in layout and triggers, Why proof-reading is errorprone, Boundary errors – what are they and how to prevent them leading to omission errors, Case studies on process errors, Case studies on document errors Contact: Susan Lynn 732.356.5800 [email protected]

Good Commissioning Practices Integrated Project Services This session will focus on the commissioning process and how it can enhance project delivery. Measuring commissioning value, identification of cost saving opportunities, sequence of activities and commissioning master plans will be stressed.

Contact: Scott Hickok IPS, 610-828-4090 [email protected]

Designing a CIP System with an Eye to PAT Omnival, Inc. Abstract: Designing a CIP System with In-Process Controls will provide for a system that is reproducible and so, validatable. This seminar will focus on the following: Basis of Design Points of Use Layout Sequence of Operations Components Instrumentation PLC Variables PAT Commissioning

Contact: Janit Buccella 908-310-2941

Integrated Commissioning and Qualification Commissioning Agents, Inc. Abstract: This presentation discusses leveraging commissioning to streamline qualification using ISPE Commissioning and Qualification principles. This will be nuts and bolts "how to" for a project team and will include information on major integration issues and what types of commissioning and construction documentation can be used to support qualification. In addition, basic tenants of the ISPE Commissioning and Qualification Baseline Guide will be covered including Good Engineering Practices (GEP), system impact assessments, change control, commissioning, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Contact: Matthew Ferrier (860) 961-4311 [email protected]

Risk Based Approach to Qualification Commissioning Agents, Inc. Abstract: The FDA and EU are advocating a risk based approach to qualification and validation in order to concentrate resources on the critical areas of the manufacturing process. The EU GMP's Annex 15 (Qualification and Validation) says a risk assessment approach should be conducted to determine the scope and extent of validation. This discussion will cover the latest regulatory guidance on risk management and provide details on various risk management methods including impact assessment and functional area analysis processes. Contact: Matthew Ferrier (860) 961-4311 [email protected]