Integration of Risk Management Principles and Activities into the Pharmaceutical Quality System

Upon completion of this course, attendees will understand how to effectively meet and integrate the requirements of Quality Systems Management and Risk Management for drugs and biologics.

Course Objectives Include:

• Understanding the principals of Risk Management, the terms and their relationships
• Know the key Risk Management and Quality System regulations, requirements, standards, and guidance
• Develop a working knowledge and application of tools used in Risk Management
• Develop an understanding of how to integrate RM principals into a pharma/biologics QS
• Understand and appreciate Product Life Cycle considerations and the significance of different types of risk evaluation in product development, process development, commercial tech transfer and ongoing GMP operations. 

Introduction and Overview

• Risk: Patient-Product-Process
• Legacy vs. Life Cycle Compliance Approach
•       PAT-QbD-ICH Q8, Q10
• Product Life Cycle Quality and Risk Management

Regulatory Perspectives and Requirements

• Understanding the difference between: laws, regulations, guidances, and standards
• Quality System and Risk Management requirements and guidance
•          US,  EU,  ICH/Harmonized
• Comparisons between the EU, U.S., and other countries 

Key Elements of Quality Risk Management

• Organized Approach/Top level integration with the QMS
• Risk Assessment
•      Risk Identification-hazards and harm matrix
•      Risk analysis and evaluation-Introduction to
       key risk tools
• Risk Control and Reduction – Reliability and Detectability
• Risk Acceptance
•       Severity/Likelihood Matrix-Considerations
        for determining Acceptable Risk 
•       The importance of the Risk/Benefit analysis

Understanding Key Risk Analysis Tools

• Process Mapping 
• Hazard Analysis and Critical Control Points (HACCP) 
• Hazard Operability Analysis (HAZOP) 
• Cause and Effect Analysis 
• Fault Tree Analysis (FTA) 
• Failure Mode Effects Analysis (FMEA)

Group Discussion

• We will work together to evaluate and find possible /strategies to risk scenario brought forward by class participants.

Risk Management Tools and Application to Product Development and Product Risk

• Patient/Consumer risk and the Quality Target Product Profile
• QbD-Risk Control- Product Development
• Product Realization and Specification of Critical Quality Attributes

RM Tools and Applications in Process Development and Validation

• Product/Process Development Transition
• Process Understanding and Design Space
• Scale Up- Process Validation 

Implementing Risk Management Integration

• Identifying and overcoming the obstacles and pitfalls
• How to start

RM for Maintaining and Improving cGMP Operations

• Continuous Process Verification
• CAPA
• Tech Transfer
• Change Control

Next Level Risk Management Topics and Issues

• Organizing a process and program for RM Integration
• Preconception, misinterpretation: Their potential impact on Calculating Risk
• Establishing Risk Responsibility-The importance of risk control effort being proportional to the magnitude of risk
• Recap/Case Discussion

"I found the course to be the right balance of informative and enjoyable. The interactive nature made the course interesting."

Teri R., R&D Supervisor, Hitachi/MSSI

"The course was exceptional! I enjoyed the interactive style of the Course Director."

Krishna S., CEO, MSSI

"It was a well-run course. I enjoyed all of the additional material provided on the flash drive."

Erin J., Quality Systems Specialist, Sterilmed / J&J

"Among the best courses I’ve taken outside of school. The course director was very knowledgeable and engaging."

Patrick E., QC Analyst, Recro Pharma Gainesville

"This course was very engaging and most importantly, the instructor was very knowledgeable. I was particularly grateful for the depth of discussion regarding medical devices vs. Pharma. So many courses I've taken have been totally Pharma focused."

Kerry F., Medical Affairs Manager, Getinge

"The course was able to present real world examples that a QA/RA professional can relate to. The instructor led at a great pace and to every question provided a complete answer. I felt understood and really learned when I had an inquiry."

Craig D., QA/RA Scientist, Promega

"I was very satisfied with this course. It’s what I expect from CfPIE. The interaction with the course instructor was very useful and I enjoyed the exercises and the workshop."

Amir S., Design Quality Engineer, Zimmer Biomet

"The presenter was extremely knowledgeable the examples provided were very beneficial."

Gary S., Manager, Quality and Compliance, Morphotek

"The course was a very good introduction to the concept of integrating Risk Management into the existing Quality management System. It was well presented and well explained."

Ladi O., Device Safety Leader, Bayer

"Great course, great spokesperson! Highly recommend! I for one especially appreciated the following, Real-life examples from all walks of business, Providing the standard, laws and guidance from a global perspective was very refreshing and enlightening and the Workshop was great as well."

Goldi, Director, Pharm. Tech., Otsuka

"The material was thorough and comprehensive. The Course Director is clearly an expert on risk management and the right person to teach the course. He is articulate, patient, and can cater the material to an audience in many different groups and industries. In addition, he has created several useful workshops that forced the class to apply the risk management principles he was teaching."

Jonathan K., Quality Systems Specialist, Boehringer Ingelheim Chemicals

"All course materials were helpful, especially the worksheets. I will be able to bring them back to my company and start using them to improve our processes. Instructor gave good insight into the FDA perspective and what an investigator would be looking for in a risk management plan."

Leah S. Proc. Development Engineer, Alkermes

"Excellent course, well delivered and useful notes I can refer to later. Good group exercises."

Michael K., Department Manager, PM Group

"This class will enable me to network and gain a better understanding of risks. Great job!"

Kim B., Manager of GMP Quality, Merck

"The Course Director was excellent in explaining material. When I came in, I didn't know much about the topic and when I left on the last day I felt like I could share ideas with others."

Melissa R., Scientist, Business Operations, Glaxo (GSK)

"The exercises give 'practical application' to the information given in the lecture."

Christy, S., Quality Assurance, W.L. Gore & Associates

"This course provided excellent tools that we will be able to implement immediately."

Scott W., QA Manager Johnson & Johnson

"The complicated topics were made simple and understandable for new QA staff."

Raymond N., Sr. Medical Advisor & Safety Officer, Baxter