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20: Short Courses [clear filter]
Sunday, June 16
 

9:00am PDT

92F: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop
Component Type: Tutorial
CE: ACPE 7.50 Application UAN: 0286-0000-24-515-L04-P; CME 7.50; RN 7.50

Pre-registration required and is an additional fee.

Already registered? Log in to DIA's My Account/ My Events.

According to the FDA (as well as other regulators), CAPA management and lack of proper investigation of challenges is a top observation among companies in the industry. In this workshop, we will demonstrate by interactive case study sessions how to perform a proper investigation into a robust root cause analysis using industry standard tools, in a toolkit approach. Also, we will explore the challenges of proper CAPA planning and defining appropriate effectiveness checks to ensure these observations do not occur again and how to properly document what was performed. We will use some direct case studies from various FDA 483s to show real-life situations on how to apply our toolkit approach to avoid action by regulators and ensure compliance in your processes and company culture.

Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Who should attend?

Professionals who want a better understanding of how to perform a robust root cause analysis and CAPA plan to shift from a reactive organization to a proactive organization. This workshop is best suited for those in regulated industries in various industry areas such as quality, regulatory, operations/production, laboratories, etc.

Learning Objectives

  • Determine the best approach to train individuals on best industry practices in CAPA management
  • Utilize proven tools, in a toolkit format, to properly investigate observations and formulate robust CAPA plans and Effectiveness Checks to ensure compliance and remediation of observations
  • Analyze case studies for techniques and strategies that will help solidify how to use the different tools and why to use each one



Speakers
avatar for Christy Mazzarisi

Christy Mazzarisi

Quality COE Lead, Network Partners Group, United States
Head of Quality, with a broad background in Pharmaceutical and Laboratory sciences (specializing in business development) with R&D and commercial manufacturing (sterile and non-sterile) experience with over 17 years industry practice. Overall background and specialties include GMP... Read More →
avatar for Danielle Metzger

Danielle Metzger

Consultant, Network Partners Group, United States
Accomplished Quality Professional with a broad background in pharmaceutical life sciences having R&D through commercial experience with 25 years of practice in Quality & Manufacturing, global consulting, and business development. Experienced and well versed in GMP and have working... Read More →
avatar for Renata Skros

Renata Skros

Quality Consultant, Network Partners Group, United States
I have been working in the Pharmaceutical Industry since 2000, with experience ranging in Quality Control Microbiology, Quality Systems, and Regulatory Affairs. I have extensive knowledge of both Commercial (sterile and non-sterile) and Research & Development. I specialize in GLP... Read More →
avatar for Brendan Burns

Brendan Burns

Manager, Document Control & Training, Mersana Therapeutics
Brendan is a Manager, Document Control & Training at Mersana Therapeutics, with over 15 years of biopharma industry experience in development landscapes ranging from preclinical to commercial organizations. Overall background includes roles ranging from manufacturing operator on the... Read More →


Sunday June 16, 2024 9:00am - 5:00pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am PDT

93F: Leadership Bootcamp
Component Type: Tutorial
CE: ACPE 7.50 Application UAN: 0286-0000-24-516-L04-P; CME 7.50; PDU 7.50 PMI 2166YFM51Z; RN 7.50

Pre-registration required and is an additional fee.

Already registered? Log in to DIA's My Account/ My Events.

Whether you are a manager, a team leader, or simply someone who wants to be more influential in your personal and professional life, this short course will help you develop the skills and knowledge you need to be an effective leader. You will have the opportunity to practice and hone your leadership skills and receive feedback from others. Identify your strengths and weaknesses as a leader and how to leverage them in your everyday life.

This leadership bootcamp will focus on the following key areas and provide hands-on opportunities to apply your leadership skills and practice overcoming common leadership challenges. This workshop will be delivered through a combination of lectures to introduce key concepts and group exercises for role-playing and hands-on practice the key elements of leadership. Participants will have the opportunity to ask questions and learn from an experienced leader, mentor, and coach, and to practice their leadership skills in a safe and supportive environment.

By the end of this bootcamp, participants will have honed their leadership skills and will be able to:
  • Understand the key principles of effective leadership and stakeholder management
  • Build strong team alignment with team members that collaborate well with one another
  • Develop the skills to influence others without requiring formal authority
  • Motivate and inspire others to achieve their goals
  • Communicate clearly and effectively especially when delegating to others
  • Solve problems effectively
  • Manage conflict
  • Practice the art of negotiation
  • Make sound decisions under pressure
  • Lead people through change effectively
  • Adapt their leadership style to the individual situation
  • Be respected as a leader with integrity


Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Who should attend?

Professionals involved in or interested in becoming a more effective leader, regardless of their current position or title.

Learning Objectives

  • Apply the key principles of effective leadership and stakeholder management at all levels in an organization
  • Perform hands-on practice strategies to overcome leadership challenges such as aligning teams on a common vision, dealing with difficult people, prioritizing and managing expectations, developing effective negotiation strategies, making tough decisions, facing change, etc.



  • Speakers
    avatar for Susan Carino

    Susan Carino

    Director, Program Management, Mammoth Biosciences, United States
    Susan Carino is a Director of Program Management with Mammoth Biosciences. She has over 30 years of industry experience in R&D across numerous therapeutic areas. She has led diverse cross-functional program teams engaged in complex product development of pharmaceuticals, biologics... Read More →
    avatar for Yoshiko Stowell

    Yoshiko Stowell

    Head of Regulatory Affairs, Neuron23, United States
    Yoshiko Stowell, PhD, PMP is a Head of Regulatory Affairs at Neuron 23. She has over 19 years of diverse experience in Regulatory Affairs (Clinical and CMC), R&D, and Project Management. She has experience in all states of development from proof of concepts to global Phase III Clinical... Read More →


    Sunday June 16, 2024 9:00am - 5:00pm PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      13: ProfDevelopment, Tutorial |   20: Short Courses, Tutorial
     

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