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Wednesday, April 11 • 10:30am - 12:00pm
Session Q - GMP Track

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Q-1  Transforming Change Management with Modern Solutions

Abstract:
Continued growth in global outsourcing, greater regulatory scrutiny, and legacy systems has led to unprecedented levels of complexity for managing quality. Change management is often a cross-functional process with global stakeholders. However, with different tools across multiple departments, making intelligent decisions in a timely manner is difficult.
Efficiently assessing impact, orchestrating, and executing a change plan is critical. Some changes have regulatory impact ­­and require approval from each country’s health authority before shipping product. With extensive coordination needed between quality, manufacturing, and regulatory, companies need to effectively manage change while balancing inventory and product ship decisions.

Modern systems provide greater visibility and enable seamless processes between functional areas. Equipped with better intelligence and more efficient changes, companies decrease risk and achieve agile decision-making. In this presentation, you will learn how to transform change management, including:
• Providing a framework to systematically assess global operational and regulatory impact
• Guidance on roles and responsibilities across the change management process
• Streamlining processes between quality and regulatory departments, or QMS and content systems
• Facilitating efficient execution of multiple tasks for a change plan
• Structuring change releases and putting into effect in a global environment

Category:
Good Manufacturing Practices

Level of Content:
Advanced

Q-2  Execution of a proper event investigation


Abstract:  An article examining recent GMP inspection data from CDER and MHRA (Medicines and Healthcare Products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list over the past four years. We as an industry cannot seem to get this quite right.” I admit I agree.  
During this presentation, we will discuss the reasons why executing a proper Event Investigation still seems to elude us and how to structure your compliance system to:
  • Standardize of the process for performing an Event Investigation, thereby eliminating inconsistencies in execution and documentation.
  • Capture the process in one procedure instead of several procedures resulting in a more streamlined management process.
  • Ease the training burden and promote greater compliance with dedicated focus and specificity on a process used by many employees.
We will also detail the process for navigating an Event Investigation, specifically:
  1. Describing the event
  2. Collecting the data
  3. Performing a root cause analysis (RCA)
  4. Performing impact and risk assessments
  5. Determining Corrective and Preventive Actions (CAPAs) and document changes
  6. Conclusions and Effectiveness Checks (ECs)
Category:
Good Manufacturing Practices

Level of Content:
Intermediate

Moderators
MC

Megan Callan

Manager Regulatory Compliance, Charles River Laboratories
Megan Callan is the Manager of Regulatory Compliance at Charles River Laboratories. She is responsible for quality assurance required for GLP and GMP testing conducted at the Cleveland, OH site. She started her career working in microbiology laboratories for pharmaceutical/biotech... Read More →

Speakers
avatar for Judy Carmody

Judy Carmody

Founder and Principal, Carmody Quality Solutions
Judy Carmody, Ph.D., is the founder and Principal Consultant of Carmody Quality Solutions, LLC., a dynamic, innovative consulting agency that provides Quality services to the pharmaceutical, biologics and medical device industries. Dr. Carmody is the former president of Avatar Pharmaceutical... Read More →
avatar for Mike Jovanis

Mike Jovanis

Veeva Systems
Mike Jovanis is Veeva Systems’ Vice President of Vault Quality at Veeva Systems, and is an accomplished executive and recognized leader in the quality technology space. Over his decade-long career in the life sciences industry, he has proven instrumental in building Sparta Systems... Read More →


Wednesday April 11, 2018 10:30am - 12:00pm
Platinum 1&2

Attendees (14)