Consultancy

Training

My knowledge and years of experience in Process Industry Part are expose during the training I give. Some of these courses are given by ISA, where I work as a freelance trainer. Other training cources are organised by Project & Quality TrainingPRP10211LOG PMS

The following courses are given periodically.

In the training the theory is followed by  practical experiences. Workshops are used in the training and many opportunities are available for  the student to bring his own situation into the course. The course documentation is in English.

Of course it is always possible to tailor courses to get focused on your project or situation, where the course is also on your site can be given.

For training in Six Sigma and Lean manufacturing, I refer you to Van Eekhout Consulting

Batch control using the ANSI/ISA-88 standards

This course presents an approach to develop functional requirements/specifications using the models and terminology defined in the ANSI/ISA-88 batch control standards. A review of the characteristics of batch manufacturing systems is included. Participants explore the ANSI/ISA-88 concept that separates the recipe from the equipment. Course includes a methodology that defines an object approach based on ANSI/ISA-88 that promotes the reuse of these objects from one project to the next.

More information.

Applying the batch control standard ANSI/ISA-S88.01

This seminar will provide essential information for professionals working in batch process, especially in the pharmaceutical, pulp and paper, food processing, chemical processing, and air and gas industries. Leave with an understanding of the goals of the standard, how to apply the standard, where it can be used, issues and problems the standard addresses, and an understanding of the recipe and equipment structures used for batch control.

More information

Validation in the pharmaceutical (and medical device) industry is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements.

Validation according the FDA is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." (FDA 1987). A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification.

Validation also concerns computerized systems. The ISPE’s guide GAMP® 5 A Risk-based Approach to Compliant GxP Computerized Systems published in February 2008 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner.

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

Implementing business to MES integration using the ANSI/ISA-95 standards

Many manufacturing firms have made significant investments in flexible shop-floor execution systems and in sophisticated enterprise planning (ERP) systems. Those investments, however, cannot yield their full potential until each has access to the information and capabilities of the other. The ANSI/ISA95 standard addresses that coordination problem by providing a sound, robust definition of business activities and the information that must flow between those two realms. This course also teaches the terminology used in Information Technology (IT) departments, so that manufacturing and IT personnel can effectively work together on integration projects.

This course defines an approach to integrating manufacturing systems with other business logistics systems using the models and functions defined in the ANSI/ISA95 standard. The course describes in detail the information that must be shared between enterprise (ERP) and shop floor systems. Enterprise/Control integration is the integration of the business and administrative processes managing the order and product with the manufacturing plant responsible for real-time process execution. Business systems focus on optimizing business processes and operational decision-making while manufacturing control systems focus on the control and optimization of real-time production processes and resources.

More information

Manufacturing Execution Systems (MES) bridge the information gap between ERP systems and process control systems. When these type of systems are used in a GMP regulated environment these systems may be subject to validation. ISPE issued a Good Practice Guide (GPG) on this subject.

After a summary of GAMP 5 and ISA-95, the GPG is explained in a practical way.
More information