Class Notes for Client Management Systems - Class 2
Class Logistics
Attendance recorded via Canvas on the left hand column, attendance button.
Attendance open for fifteen minutes from the start of class.
Instructor will mark anyone who attended last week.
Overview of Class Structure
The session is the second class focused on Client Management Systems.
Review of outstanding slides from the previous session.
Three new slide packs to be covered in today's class.
An exercise will be incorporated to engage students.
Standard Operating Procedure (SOP) Assignment Overview
SOP assignment is the first assignment and is worth 15% of the final grade.
Students must create an SOP for a fictional company.
The SOP can relate to either a technical topic or a quality system topic as specified in the guidelines.
Notification of the selected topic is required via email by the end of Class 3 (next Monday at 09:30).
Recommendation: Submit topic early to ensure no duplication with peers.
SOP Requirements
Create a fictional company name to be used in the SOP.
Structure the SOP according to Good Manufacturing Practices (GMP) SOP format, including key sections such as:
Table of contents
Comprehensive sections as outlined in assignment guidelines
Length: Minimum of 5 pages (excluding cover page).
Written assuming a manual SOP system, with hand signatures for approvals.
Topics available for selection are listed in the assignment.
Grading will consider content quality in alignment with US regulations and grammatical correctness.
The final submission is due on Class 5 via email (February 23), preferably in Word format for easier commenting and grading.
Key Dates and Actions
Notify the instructor of the selected SOP topic by email by Class 3.
Complete assignment submission by email by Class 5.
Classroom Operations
Reminder for new students to ensure they check into the Canvas attendance system.
Engagement noted: only a few students present initially, one has indicated lateness.
New student introduced halfway through the session: Zoma, from Fox Chase Cancer Center.
Review of Previous Slides
What Makes a Healthy Quality System
Importance of aligning goals with quality-related objectives.
Quality responsibility should extend across the organization, not just to designated teams (Quality Assurance or Quality Control).
Annual Goals and Quality Systems
Operational goals should consider quality impacts and not solely focus on cost reduction.
Value of a Quality System
A quality system should address:
Reduction of nonconformances and deviations.
Fewer health authority observations or recalls.
Facilitation of preventative measures, not only reactive fixes.
Effective management and clear role assignments leading to inspection readiness.
Strengthening employee retention through clear roles and a strong quality focus.
Change Management System
Highlighted a real-world example regarding an overly complex change control process resulting in significant delays, impacting operational timelines and production.
Quality Metrics and Management Responsibility
Management should review quality metrics regularly, providing visibility of the quality system health and signaling accountability.
The concept of Gemba walks introduced: management visits operational areas to engage with employees and understand challenges directly.
Discussion on Quality Management Systems
Introduction to ICH Guidelines
Overview of the International Conference on Harmonization (ICH), emphasizing the importance of quality by design (QbD) and risk management.
Definitions provided for terms pertinent to this class are integral to understanding risk assessments in pharmaceutical contexts: e.g., definitions of biologics vs. small molecules.
ICH Quality Documents
A focus on the three key ICH documents:
ICH Q8: Pharmaceutical Development
ICH Q9: Quality Risk Management
ICH Q10: Pharmaceutical Quality Systems
Risk Management Overview
Introduction to Risk Management in Pharmaceuticals
Risk is characterized as an event that may occur and could result in an adverse effect.
Two key factors used to assess risk:
Likelihood of occurrence: scored from 1 (very low) to 5 (very high).
Consequence if the event occurs: scored similarly from 1 (insignificant) to 5 (catastrophic).
Risk Index Value (RIV) calculated by multiplying likelihood by consequence (e.g., likelihood=2, consequence=4 would yield RIV=8).
Risk Acceptance Decisions
Discussed the spectrum of risk tolerance where organizations may have different thresholds for risk acceptance based on internal guidelines and objectives.
Class Exercise and Application of Risk Assessments
Students engaged in an exercise to rate risks associated with a workforce scenario based on observations presented in a provided image. Teams analyzed likelihood and consequence, with discussions surrounding the process of reaching a consensus on RIV.
Teams utilized a risk rating scale to determine appropriate scores for risks in their group discussions.
Closing Remarks
Recap of upcoming topics in next class:
Continued exploration of SOPs, written standards, and case studies involving documentation issues.
Action required: submit selected SOP topic via email by the end of next week's class.
Q&A session to clarify any remaining questions or concerns about the assignments or class content.
Additional Notes
IRC note: Risk appetite and the implications of risk management touched upon; discussions around tolerability relevant for decision frameworks in quality management.
Q&A: Address the balance between estimating risks realistically versus the potential need to err on the side of caution; emphasize the importance of adequate data and context in risk evaluations and decision-making.