ISPE CEUs: 1.5
Type: Classroom Training Course
The successful delivery of manufacturing facilities regulated by various authorities, poses significant
challenges to manufacturers, engineering professionals, and equipment suppliers. This interactive course will
provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program,
integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management
Systems and define organizational capabilities to support the new C&Q program.
Through interactive workshops participants will more fully understand and apply the principles of ASTM
E2500-07 and ICH documents (Q8 (R2), Q9, and Q10) to the documented verification of pharmaceutical and
biopharmaceutical facilities, systems and equipment that are suitable for their intended purpose. Templates
will be developed to facilitate the translation of the scientific knowledge about the product and process
into documented specification, design, and verification of facilities, systems, and equipment.
Example “case studies” based on real-world projects will be used to provide participants with the
opportunity to learn and practice how to develop user requirements, perform risk assessments and develop
planning for commissioning and qualification based on the identification of the quality-critical aspects of
facilities and equipment and utility systems and controls.
- Core Concepts and Terminology
- Workshop 1 – User Requirements
- CQA’s, CPP’s, Critical Aspects
- Workshop 2 – Risk Assessment
- Use of Risk Assessment Data
- Workshop 3 – Critical Aspects
- Design Review
- Workshop 4 – Design Review
- Verification Planning
- Workshop 5 – Verification Planning
- Acceptance and Release
- Workshop 6 – Acceptance And Release
- Workshop 7 – Audit Of Verification Package
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom
course. Access information will be provided via email one week prior to the start of the training event.
Take Back to Your Job
At the end of the two-day workshop, attendees will:
- Understand user requirements, how their role in the verification process, and how to develop “SMART”
- Have practiced developing Process User Requirements (PURs) on an example project.
- Understand how to use risk assessment to assure control strategies are robust and to develop and identify
“Critical Aspects” – the functions and features that must be “Qualified”.
- Have participated in an FMEA-style risk assessment for an example project and developed a Critical
Aspects list for that example.
- Understand the regulatory drivers for Design Review; be familiar with ASTM E2500 Design Review
requirements, and implementation and the range of options for documenting Design Reviews.
- Have participated in conducting a design review using provided design spec, drawing, and sequence of
- Understand how to prepare an acceptance and release report and TOC of required attachments, or reference
list of pertinent information.
- Understand the flexible approaches to verification to improve effectiveness and lower cost of inspections
- Efficient and focused use of resources, ensuring that these resources are directed to quality critical
aspects and activities for achieving fitness for intended use.
- Examine options for better utilization of resources and conformance to GxP regulations.
- Define organizational roles and responsibilities for risked based C&Q program implementation,
including defining critical aspects, verification strategies, acceptance criteria, testing execution, and
review and approval of test results.
- Define change management strategies to adjudicate planned departures from requirements and
- Know how to develop approaches for the leveraging of supplier activities to avoid repeated specification
and verification activities.
- Review the ASTM E2500 and FSE Guide concepts including sources of Input, SMART requirements, PPURS vs.
GURS, capturing requirements when additional info is still required (i.e. final control band).
- Develop user requirements document for the process / system using the provided templates.
- Using the templates provided, develop the FMEA to identify Critical Aspects of a System and develop a
- Review the Regulatory Drivers for Design Review and identify critical aspects and how Design Review can
be incorporated and discuss how process control strategy can be defined.
- Evaluate Implementation and range of options for documenting Design Review including One Page Memo;
Traceability Matrix, Pre approved protocol, and detailed documentation of detailed design review
- Discuss who should develop and who should approve. Discuss requirements around use of vendor testing,
third party testing, etc.
- Know how to handle departures from specification and deviations.
- Identify the required content of an acceptance and release report and who should approve it.
Attendance Suggested For
This course will be of interest to those following the latest industry and regulatory initiatives,
including application product and process understanding within qualification and the science- and risk-based
approach with emphasis on commissioning and qualification of equipment and systems.
- Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science
and Risk-based approach to Quality Risk Management.
- Project engineers, project managers, commissioning and validation professionals, engineering service
providers, and quality assurance personnel involved in qualification and validation and regulatory.
Community of Practice (COP)
This training course is of particular interest to existing and future members of the ISPE Commissioning and Qualification Community of Practice (COP).
Continuing Education Units
ISPE will provide continuing education units (ISPE CEUs) for all North American and European
courses. CEUs are nationally recognized units of achievement designed for those individuals continuing
their education in their chosen field or profession. Verification of CEUs is based on attendance as
well as satisfactory completion of all evaluation materials. Statements of credit will be available for
download in your ISPE account within four weeks of the completion of training. Instruction for download
will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU