Training Classes
Standard training classes are offered on-site. Classes can also be tailored to suit individual needs.
- ANSI/ISA-95 Enterprise/Control System Integration - Overview
- ANSI/ISA-95 Enterprise/Control System Integration - Information
- ANSI/ISA-95 Models of Manufacturing Operations
- Batch Control Using the ANSI/ISA-88 Standard
- Managing Corporate Product Definitions Using ANSI/ISA-88 General Recipes
- Understanding
21 CFR Part 11 for Control Systems
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ANSI/ISA-95
Enterprise/Control System Integration - Overview This class is an overview of the ISA-95 and IEC/ISO 62264 standard for Enterprise System to Control System Integration. It describes the business reasons for the standard, the benefits that companies have achieved with Enterprise/Control System Integration, and an overview of the type of information that is exchanged between business systems (ERP, SCM, PLM) and manufacturing systems (MES, LIMS, WMS, and CMM). The class includes an overview of the XML schemas developed by the World Batch Forum, that are currently being used in business to manufacturing integration. (Code: BRL-95-OH) |
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ANSI/ISA-95
Enterprise/Control System Integration - Information This
class describes the ISA-95 and IEC/ISO 62264 standard for Enterprise
System to Control System Integration. It describes the information that
is exchanged between business systems (ERP, SCM, PLM) and manufacturing
systems (MES, LIMS, WMS, and CMM). Formal models for this information
are presented, including mapping of this information to SAP data
structures used in ERP-to-MES integration. The class includes a
detailed look at the XML schemas developed by the World Batch Forum,
that are currently being used in business to manufacturing integration.
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ANSI/ISA-95
Models of Manufacturing Operations This class defines the emerging model of manufacturing operations defined in the draft ANSI/ISA-95 Part 3 standard. This model is an extension of the MESA model for MES and describes a common structure that is being used by multiple manufacturing companies to describe their production operations. The class also defines mapping of the model activities to different types of software solutions, such as MES, plant data historians, recipe management systems, and production analysis tools. The class also describes the activity model for quality lab operations, maintenance management operations, and inventory transfer operations. Multiple companies are using the ISA-95 Part 3 models to specify vendor systems in MES, maintenance, and quality. (Code: BRL-95-P3) |
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Batch
Control Using the ANSI/ISA-88 Standard This class presents the ISA-88 standard for batch control systems. The class presents the concepts and implementation of batch control systems using the ISA 88 standard and the concepts of modular batch automation. The class covers the recipe-equipment separation required for flexible manufacturing, the S88 recipe hierarchy, the equipment hierarchy, and the methods for organizing equipment control for reusable and modular control. (Code: BRL-88-P1) |
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Managing
Corporate Product Definitions Using ANSI/ISA-88 General Recipes This class presents the ISA-88 Part 3 standard, General and Site Recipes. The class presents the management of corporate product definitions using the ISA standard for general recipes. General and site recipes and the elements that make up the recipes are defined. The class covers how general and site recipes are used within a manufacturing company. The class also covers the benefits of general recipe use, and how they relate to master and control recipes used in production. (Code: BRL-88-P3) |
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Understanding
21 CFR Part 11 for Control Systems This
class presents an overview of the requirements placed on manufacturing
in pharmaceutical and biotech for the USA FDA regulated markets. It
describes the requirements for electronic records and electronic
signatures as specified in the USA FDA 21 Code of Federal Regulations,
Part 11. This regulation describes the controls and procedures that
must be placed on information maintained in electronic form and on
electronic documents used in place of officially signed documents. |
Instructor - Dennis Brandl
Dennis
Brandl has been an instructor in batch control systems,
business-to-manufacturing integration, control system and software
design methodologies, object-oriented programming, validation, and
regulated industry compliance for the past 17 years. Dennis is also an
instructor at ISA, teaching multiple classes at ISA conferences, and
was formally an adjunct professor at East Tennessee State University.
Dennis Brandl has also been a leading participant in the development of
the ANSI/ISA-88, ANSI/ISA-95, and NEMA ICS 12.1 standards. Dennis is
well know for his dynamic and entertaining classroom style.
| BR&L
Consulting, Inc. 208 Townsend Ct, Suite 200 Cary, NC 27518 - USA (FAX) +1-832-201-0554 |
Dennis Brandl (TEL) +1-919-852-5322 (CELL) +1-919-656-2205 info@BRLConsulting.com |