HomeWebcastPractical Tips in Managing Supplier Risks in the Life Science Industry
Online CLE Life Sciences CLE

Practical Tips in Managing Supplier Risks in the Life Science Industry

Live Webcast Date: Wednesday, November 08, 2017 from 12:00 pm to 2:00 pm (ET)
Health Care CLE & CPERecording

Online CLE Life Sciences

Join us for this Knowledge Group Online CLE Life Sciences Webinar. For the past years, disruptions in the life science industry’s supply chain have been continuously creating preeminent risks and challenges for businesses and organizations. As organizations extend their reach to suppliers all throughout the globe, ensuring the security and integrity of their supply chain has been a lot more complex than ever.

In this Webcast, a seasoned panel of thought leaders and professionals brought together by The Knowledge Group will provide the audience with the practical tips and best strategies in Managing Supplier Risks in the Life Science Industry. Speakers will go beyond the basics and present to the audience the overview of the key attributes of supplier risks management in the life science industry and provide the best strategies in maintaining and rationalizing the supply base.

Key topics include:

  • Identifying and Managing Supplier Risks in the Life Sciences Industry
  • Supplier Relationship Management (SRM)
  • Risk Mitigation Strategies
  • Describing and Optimizing the Role of Supply Base
  • Strategic Supplier Selection: An Outline
  • Trends and Developments

Agenda

SEGMENT 1: 
Florian Czaszewicz, Industry Solutions Consultant
Pilgrim Quality Solutions

  • Risk Management and the Supplier Framework within Life Sciences
  • The Importance of Regulations
  • Performance Objectives
  • Pre and Post Phases of Supplier Selection
  • Practicalities for Efficiently Managing Supplier Risks

SEGMENT 2: 
Carmine Jabri, President/CEO
E.M.M.A. International Consulting Group, Inc.

  • Industry trends in the Life Sciences that impact risk
    • 1a) Pace of change
    • 1b) Increasing globalization of market and suppliers
  • Steps to enhance risk management
    • 2a) Leverage technology, e.g., doc support, compliance training, best practices workflow
    • 2b) Prioritize proactive comprehensive risk assessment, e.g., regulatory compliance gaps, reputation risk, cyber
    • 2c) Look beyond risk assessments, i.e., changes in procedure have no historical data and evade the parameters of risk assessment. Don't pigeonhole scope

SEGMENT 3: 
Aida Markham, Senior Director, Compliance
QACV Consulting

Risk-Based Supplier Qualification and Management: A tool for preventing FDA enforcement actions

Due to the growing trend to outsource drug manufacturing outside the United States, the FDA has increased their attention on supply chain management in recent years.  As a result, more and more companies are faced with the challenge of managing a large number of suppliers across the globe while assuring the agency that they are exercising sufficient and adequate controls that ensure patient and public safety.  This presentation explores current trends, common pitfalls and major challenges in supply chain management and presents an alternative look at the supplier audit process: a risk-based approach.  The presenter will discuss:

  • Classifying suppliers based on risk to determine the amount and extent of auditing and controls to be exercised.
  • General guidelines, best practices, and key strategies for planning, conducting and reporting on supplier audits.
  • Preparation and content of procedures, checklists and templates to assist in the supply chain management process.

SEGMENT 4: 
Kenneth Christie, Chief Operating Officer
VTS Consultants, Inc.

Importance of Quality Agreements;

  • Expectations found in the current “Guidance to Industry” issued in November 2016
  • Applicable regulatory requirements
  • Main points to be covered in quality agreements
  • Regulatory deficiencies cited regarding the lack of quality agreements, or assurances that they were being properly managed.
  • Impact on the state of control for supply chains. 

Who Should Attend

  • Quality Assurance Professionals
  • Quality Engineers
  • Quality Control Managers
  • Directors of Quality
  • Chief of Quality Management
  • VP of Quality
  • Regulatory Affairs Specialists
  • Regulatory Associate/Coordinator
  • Vice President/Head of Regulatory Assurance
  • Drug Manufacturing Executives
  • Pharmaceutical Companies

Online CLE Life Sciences

SEGMENT 1: 
Florian Czaszewicz, Industry Solutions Consultant
Pilgrim Quality Solutions

  • Risk Management and the Supplier Framework within Life Sciences
  • The Importance of Regulations
  • Performance Objectives
  • Pre and Post Phases of Supplier Selection
  • Practicalities for Efficiently Managing Supplier Risks

SEGMENT 2: 
Carmine Jabri, President/CEO
E.M.M.A. International Consulting Group, Inc.

  • Industry trends in the Life Sciences that impact risk
    • 1a) Pace of change
    • 1b) Increasing globalization of market and suppliers
  • Steps to enhance risk management
    • 2a) Leverage technology, e.g., doc support, compliance training, best practices workflow
    • 2b) Prioritize proactive comprehensive risk assessment, e.g., regulatory compliance gaps, reputation risk, cyber
    • 2c) Look beyond risk assessments, i.e., changes in procedure have no historical data and evade the parameters of risk assessment. Don't pigeonhole scope

SEGMENT 3: 
Aida Markham, Senior Director, Compliance
QACV Consulting

Risk-Based Supplier Qualification and Management: A tool for preventing FDA enforcement actions

Due to the growing trend to outsource drug manufacturing outside the United States, the FDA has increased their attention on supply chain management in recent years.  As a result, more and more companies are faced with the challenge of managing a large number of suppliers across the globe while assuring the agency that they are exercising sufficient and adequate controls that ensure patient and public safety.  This presentation explores current trends, common pitfalls and major challenges in supply chain management and presents an alternative look at the supplier audit process: a risk-based approach.  The presenter will discuss:

  • Classifying suppliers based on risk to determine the amount and extent of auditing and controls to be exercised.
  • General guidelines, best practices, and key strategies for planning, conducting and reporting on supplier audits.
  • Preparation and content of procedures, checklists and templates to assist in the supply chain management process.

SEGMENT 4: 
Kenneth Christie, Chief Operating Officer
VTS Consultants, Inc.

Importance of Quality Agreements;

  • Expectations found in the current “Guidance to Industry” issued in November 2016
  • Applicable regulatory requirements
  • Main points to be covered in quality agreements
  • Regulatory deficiencies cited regarding the lack of quality agreements, or assurances that they were being properly managed.
  • Impact on the state of control for supply chains. 

Online CLE Life Sciences

Online CLE Life Sciences

Florian CzaszewiczIndustry Solutions ConsultantPilgrim Quality Solutions

Florian Czaszewicz has worked within the Life Sciences industry and technology environments for almost two decades. He has held regional responsibilities for the Biomedical Operations and Regulatory Affairs IT department at Genzyme as well as the Global Regulatory Sciences Informatics division at BMS.

From business analysis, global SDLC projects, GXP Compliance Audits to post-delivery activities, Florian has designed and introduced new systems, and set up collaborative platforms for R&D organizations. In his more recent tenure as Account Manager, Florian has been accountable for the commercial success of global eClinical organizations prior joining Pilgrim Quality Solutions as Industry Solutions Consultant.

Florian currently supports Pilgrim’s European team as an industry expert who understands, demonstrates, and positions Pilgrim’s solutions, "linking" their key value to client business drivers.

Online CLE Life Sciences

Carmine JabriPresident/CEOE.M.M.A. International Consulting Group, Inc.

As co-founder of E.M.M.A. International Consulting Group, Inc., Carmine Jabri, PhD, MSJ, MSQM, MHA serves as E.M.M.A. International’s President and CEO. Dr. Jabri is an experienced Healthcare and Quality Assurance professional with more than twenty years of experience implementing, improving and directing Quality Management Systems and Healthcare Operations. 

His career includes expertise in the Biotechnology, Pharmaceuticals, and Medical Device industries. Dr. Jabri's extensive knowledge of regulations and guidelines, coupled with his training and facilitation skills, help him lead the team of E.M.M.A. International consultants to help organizations improve their quality management systems, reduce costs, reduce errors, and comply with federal, state, and international standards and regulations. Dr. Jabri is an internationally sought after quality systems expert.

Dr. Jabri holds a Doctor of Philosophy in Epidemiology, a Master of Science in Jurisprudence, a Master of Science in Quality Management, a Master of Science in Health Services Administration and a Bachelor of Science in Chemistry.

Online CLE Life Sciences

Kenneth ChristieChief Operating OfficerVTS Consultants, Inc.

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical, biotechnology and medical devices industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission (CPIP Program) as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

Online CLE Life Sciences

Aida MarkhamVice President Compliance QACV Consulting

Aida Markham is a Certified Quality Auditor with 20 years of experience in the FDA-regulated industry. Her experience is primarily related to the conduct of clinical trials in the US and the manufacture of drugs and biologics for clinical study and commercial purposes. Some of her contributions in quality assurance include the development of quality management, risk management, supply chain management, and regulatory compliance programs; auditing, audit preparedness and audit remediation; and computer systems validation. Aida has a Bachelor of Science degree in Industrial Engineering from the University of Puerto Rico and is currently pursuing a Master of Science degree in Regulatory Affairs and Quality Assurance at Temple University. She lives in Katy, TX with her family and is the Vice President of Compliance at QACV Consulting, LLC.


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Online CLE Life Sciences

Course Level:
   Intermediate

Advance Preparation:
   Print and review course materials

Method Of Presentation:
   On-demand Webcast

Prerequisite:
   NONE

Course Code:
   146665

NASBA Field of Study:
   Specialized Knowledge - Technical

NY Category of CLE Credit:
   Areas of Professional Practice

Total Credits:
    2.0 CLE

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About the Knowledge Group

The Knowledge Group

The Knowledge Group has been a leading global provider of Continuing Education (CLE, CPE) for over 13 Years. We produce over 450 LIVE webcasts annually and have a catalog of over 4,000 on-demand courses.

About the Knowledge Group

The Knowledge Group

The Knowledge Group has been a leading global provider of Continuing Education (CLE, CPE) for over 13 Years. We produce over 450 LIVE webcasts annually and have a catalog of over 4,000 on-demand courses.

Pilgrim Quality Solutions is the leader in quality compliance management software and services for Life Sciences. For more than 20 years, our solutions have automated thousands of processes across global company sites to manage the quality and compliance of life’s most important products. Our cloud-based and on-premise solutions include in-the-box best practice workflows, document and process management, dashboards, electronic signatures, audit trails, and automated validation – helping companies more easily achieve quality system compliance and pass regulatory audits. Pilgrim Quality Solutions is majority owned by Boston-based private equity firm, Riverside Partners LLC. With Pilgrim Quality Solutions as your partner, you are prepared to succeed. For more information, visit www.pilgrimquality.com.

Website: https://www.pilgrimquality.com/

E.M.M.A. International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Farmington Hills, MI.  They focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, Medical Device and all other FDA regulated industries.

Think of E.M.M.A. International Consulting Group as a ‘one stop shop’ for all of your quality and compliance needs. They provide a wide array of specialized services to their clients, backed by extensive knowledge and industry experience. E.M.M.A. International Consultants are innovative and focused on addressing clients’ needs. E.M.M.A. International’s mission is to provide significant value to clients’ operations and leave their customers completely satisfied that their expectations were fulfilled. E.M.M.A. International works within the corporate culture and alongside the employees to do the “heavy lifting” required to make improvements meaningful and permanent.

Thank you for your patience, and please let me know if you need anything else.

Website: https://www.emmainternational.com/

VTS Consultants is a recognized provider of commissioning and qualification services for facilities, equipment and utilities, a provider of GMP training services and a provider of regulatory consulting services such as supplier audits, pre-approval inspections, regulatory submissions and assisting clients with remediation and responses to GMP deficiencies. In addition, we provide QA management and QA or Validation staff augmentation. These services have been provided on a global basis (Canada, Europe, and Asia) and to clients ranging from Biotech start-ups to medical device companies and multi-national corporations of Pharmaceuticals and Cosmetics. Our company has been in existence since 1993 and we have established a reputation for quality deliverables, well received GMP training and consultants who are routinely complimented for their personalities and ability to seamlessly work with the client’s staff. A large percentage of our business is on a repeat business for our ability to deliver the scope of work on time and within budgets.

Our home office is in Amherst, MA along with senior level project managers who oversee and reside in the Midwest (Michigan and Indiana) and the south (Florida). We can consistently staff projects with qualified candidates within our client timelines and budgets. Our goal is to help you understand the regulations for which you seek assistance and to assure our approach will help you achieve compliance to them.

Website: https://www.vtsconsultants.com/

QACV was founded in 2001 and has provided quality assurance, compliance, and computer validation services to the life sciences industry for over 16 years. The company offers comprehensive, customized quality assurance, compliance and computer systems validation services to the FDA-regulated life sciences industry that meet specific GXP needs. With expertise in regulatory compliance, data integrity, project management, six sigma, risk management, and validation, QACV offers a combination of unique services and solutions that meet regulatory challenges, fit organizational needs, and achieve sustainable compliance solutions. Services offered by QACV include: data integrity assessments and implementation of data integrity programs; internal and third-party GXP audits; customized training; computer systems validation; project management; risk assessment; audit remediation; quality system development and improvement; and on-site staffing support.

Website: https://www.qacvconsulting.com/

Florian Czaszewicz has worked within the Life Sciences industry and technology environments for almost two decades. He has held regional responsibilities for the Biomedical Operations and Regulatory Affairs IT department at Genzyme as well as the Global Regulatory Sciences Informatics division at BMS.

From business analysis, global SDLC projects, GXP Compliance Audits to post-delivery activities, Florian has designed and introduced new systems, and set up collaborative platforms for R&D organizations. In his more recent tenure as Account Manager, Florian has been accountable for the commercial success of global eClinical organizations prior joining Pilgrim Quality Solutions as Industry Solutions Consultant.

Florian currently supports Pilgrim’s European team as an industry expert who understands, demonstrates, and positions Pilgrim’s solutions, "linking" their key value to client business drivers.

As co-founder of E.M.M.A. International Consulting Group, Inc., Carmine Jabri, PhD, MSJ, MSQM, MHA serves as E.M.M.A. International’s President and CEO. Dr. Jabri is an experienced Healthcare and Quality Assurance professional with more than twenty years of experience implementing, improving and directing Quality Management Systems and Healthcare Operations. 

His career includes expertise in the Biotechnology, Pharmaceuticals, and Medical Device industries. Dr. Jabri's extensive knowledge of regulations and guidelines, coupled with his training and facilitation skills, help him lead the team of E.M.M.A. International consultants to help organizations improve their quality management systems, reduce costs, reduce errors, and comply with federal, state, and international standards and regulations. Dr. Jabri is an internationally sought after quality systems expert.

Dr. Jabri holds a Doctor of Philosophy in Epidemiology, a Master of Science in Jurisprudence, a Master of Science in Quality Management, a Master of Science in Health Services Administration and a Bachelor of Science in Chemistry.

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical, biotechnology and medical devices industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission (CPIP Program) as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

Aida Markham is a Certified Quality Auditor with 20 years of experience in the FDA-regulated industry. Her experience is primarily related to the conduct of clinical trials in the US and the manufacture of drugs and biologics for clinical study and commercial purposes. Some of her contributions in quality assurance include the development of quality management, risk management, supply chain management, and regulatory compliance programs; auditing, audit preparedness and audit remediation; and computer systems validation. Aida has a Bachelor of Science degree in Industrial Engineering from the University of Puerto Rico and is currently pursuing a Master of Science degree in Regulatory Affairs and Quality Assurance at Temple University. She lives in Katy, TX with her family and is the Vice President of Compliance at QACV Consulting, LLC.

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