The successful delivery of manufacturing facilities regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. This interactive classroom 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” requirements.
- 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 ops.
- 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 and testing.
- 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 specification.
- 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 risk assessment.
- 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 sessions.
- 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 theISPE Commissioning and Qualification Community of Practice (COP).