A Condensed On-Demand Training Series on Quality Risk Management

This thorough toolbox provides training and insights on Quality Risk Management. Dive into the realm of data-driven risk management to reduce subjectivity, get professional advice on integrating risk management into change control procedures, and discover how to eliminate bias from quality risk management in pharmaceutical and biopharmaceutical operations. This toolkit is your access to improved risk management tactics, with valuable conference sessions and virtual training sessions
Data-driven Risk Management: Reducing Subjectivity
Pedro Ferreira, Director of Quality Assurance & Validation Consultancy Services, ValGenesis

ICH Q9(R1) introduced the need to manage and minimize subjectivity in risk management in order to enhance scientific sound risk based decision making. In this presentation, a practical approach to respond to this need is outlined in the context of a production process risk management.
Incorporate Risk Management into Change Management Procedures
Vinaya Kapoor, Ph.D., Principal, Regulatory Affairs, Opus Regulatory

• Assessment of Available methods – Strengths and limitations
• Critical Profile Characteristics – Level and Shape
• Profile Linearization – A New Useful Approach
• And More!
Getting Rid of Bias in Quality Risk Management in Pharmaceutical and Biopharma Operations
Ana Margarida Ventura, Tech Lead for Quality Risk Management, ValGenesis
Pedro Ferreira, Director of Quality Assurance & Validation Consultancy Services, ValGenesis
Dr. Iris M. Ziegler, International’s Director of Pharmaceutical Sciences and QbD, Corden Pharma

Part 1 – Commercial and Lifecycle Implementations of Quality Risk Management
Part 2 – Scenario 1 – Successful implementation of a digital QRM system in client X
Create a Risk-Based Approach from the Ground Up
Melody Puckett, Quality Assurance Senior Manager, ORIC Pharmaceuticals

Part 1 – Using Risk as Part of Your Quality Management System
Part 2 – Implementing Training Effectiveness Using a Risk Based Approach
Quality Risk Management Instruments
Shannon Chesterfield, Senior Director of Consulting, Azzur Group

Part 1 – Know the Tools to Facilitate Risk Management
Part 2 – Risk Management Workshop
Handout: Template for QRM Based Gap Assessments


Pedro Ferreira

Head of Validation and Quality and Risk Management Services, ValGenesis®


Pedro is currently leading the Validation and Quality and Risk Management Consultancy Services at ValGenesis, delivering Validation, Quality, Risk and Knowledge management consultancy services to life-science industry from early drug development phase to commercial coupled with a portfolio of digital solutions to help companies to meet Industry 4.0 standards. His professional background has been in the pharmaceutical and chemical industries for over 10 years, with roles ranging from Quality Control and Quality Assurance of pharmaceutical products to the quality management of computerized systems and continuous improvement projects under the GMP scope. Pedro has a degree in Pharmacy and a master’s in Biotechnology.

Vinaya Kapoor, Ph.D.,

Vice President of Regulatory Affairs, Tricida, Inc.

Vinaya Kapoor, PhD, is an accomplished regulatory leader with over two decades of experience in the biotechnology/pharmaceutical sector, across fast-paced startups and large companies at West and East Coast locations. Passionate about making a difference to patients, she has contributed to over 20 development and commercialized programs in various modalities including small molecules, biologics, vaccines and cell therapies. Prior to her role as VP Regulatory Affairs at Tricida, Vinaya worked in Global Regulatory Affairs at Janssen Pharmaceuticals (a division of Johnson and Johnson) for over a decade, at Merck & Company, and Iovance Biotherapeutics. Her expertise includes CMC drug development and regulatory affairs across therapeutic areas and development phases.

Vinaya has a PhD in Chemical Engineering from the University of Notre Dame. Vinaya serves as a CASSS Associate Director and is actively involved with American Association of Pharmaceutical Scientists (AAPS).  She is passionate about furthering interest and careers in science, technology, environment and the arts, particularly among women and youth and volunteers her time towards this.

Shannon Chesterfield

Senior Director of Consulting, Azzur Group LLC

A Life Science professional with over twenty years of experience in the Pharmaceutical, Biotechnology and Medical Device industries, Shannon Chesterfield has in depth knowledge of FDA, Canada, EU and rest of world regulations with multiple successful product launches. As Azzur Group Senior Director she is responsible for multiple consulting projects in Southern California. Shannon has spent her entire career in the life sciences industry starting as a laboratory technician and has growing her career and expertise in product lifecycle management, quality assurance and systems, manufacturing operations, design control, package and label development, project management, and risk management. Her experiences include aseptic processes, biological containment, biotechnology, oral solid dose, medical device, drug/device combination products, and in vitro diagnostics. She is a past Steering Committee member for multiple ISPE Communities of Practice and presented at several Annual Meetings on topics including risk management. She is also an active member of the Parenteral Drug Association (PDA), the American Association of Pharmaceutical Scientists (AAPS), the American Society for Quality (ASQ) and Women in Bio (WIB).

Melody Puckett

Quality Assurance Senior Manager,ORIC Pharmaceuticals

Melody is an experienced quality professional with over 13 years of FDA and ISO regulated industry experience. With a high focus on quality, compliance, and priority management and working knowledge of 21 CFR Parts 4, 11,210, 211, 820, 58, 312; ICH Q&, Q10, ISO 13485, MEDDEV, MDD, MDR, and MDSAP.

Ana Margarida Ventura

Quality Risk Management Tech Lead, ValGenesis

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