ComplianceOnline

Course Description:

The pressure has been mounting in the pharma and biopharma industries in recent years to do more with less. Analytical laboratories are no exception to this trend. Work piles up while personnel have been cut or remain stagnant. Accelerated timelines further strain resources. Constant firefighting and band-aiding results in errors as well as compliance violations. It can be argued that the cost of non-compliance is more than that of compliance.

Often Project Management (PM) tools have been reduced to Gantt charts in many pharma and biotech companies. Applying the principles of PM can bring order, planning, predictability and overall sanity to any lab management and personnel.

In this two day workshop you will learn the different tools of PM, proper mind set/expectations and sound lean lab management program skills in order to develop and implement efficient techniques. Through case study analysis we will examine best practices to provide thoughts and ideas to develop and improve the performance of your current system. Additionally, case studies will explore how management practices of your laboratory program can help or hurt your compliance liability and the legal issues that arise from nonconformance.



Areas Covered in the Seminar:

Upon completing this course participants should be able to:

  • Understand what the global best PM practices are for analytical testing laboratories
  • Utilize a systematic risk based approach to developing an effective and scientifically justified method development, validation and technology transfer process
  • Evaluate effectiveness, suitability and adaptability of Gantt charts, Excel work sheets and other planning tools to increase lab efficiency
  • Understand the difference between research testing and development testing.
  • Investigate root causes of poor method performance in customer (QC) labs and to evaluate and prioritize solutions
  • Problem solve method issues to help assess which is best for your situation
  • Develop successful lab management implementation plans
  • Perform risk assessments effectively

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar



Who will Benefit:

This course is designed for people tasked with developing, validating, maintaining and/or improving testing methods for pharmaceutical or biotechnology industries. This includes individuals that have Quality Control Laboratory responsibilities or method development responsibilities for small molecules or biologics. Anyone with a testing lab responsibility interested in making general improvements in their organization’s performance specifically related to efficiency, productivity or compliance can benefit. The following personnel is a sampling of who will benefit from this course:

  • Senior Analytical managers
  • Quality Control/Assurance professionals
  • Regulatory professionals
  • Compliance professionals
  • Laboratory supervisors
  • Process owners
  • Quality auditors
  • Analytical Specialists




Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  1. Introduction to the language and tools of Project Management (PM)
    1. Defining the problems of a modern lab
    2. How PM tools enter into the process of lab management
  2. The NIH syndrome. How things get done here.
  3. The stages of drug development continuum
    1. Recent updated agency expectations
    2. Expected changes and resistance to change
    3. Global harmonization and expectations
  4. Prevention of “firefighting”
    1. Protection of must-do activities
    2. Managing the peaks and valleys of work load in any lab
  5. Planning, Managing and Monitoring
    1. Efficiency improvement studies
    2. Qualification in-situ and initial environmental monitoring studies
  6. Designing the program
    1. Fundamental considerations
    2. Policies and procedures
    3. Risk Management as a critical tool
  1. Defining the two basic focuses of Project Management Practices
    1. Controlling the number of firefights & increasing productivity
    2. Controlling and prioritizing compliance improvement
  2. Initial establishment of historical trends
  3. Establishment of a baseline lab productivity and compliance profile
  4. Initial monitoring
    1. Setting the goals
    2. Trending
  5. Risk Analysis as a tool
    1. Setting expectations to Stakeholders
    2. Setting internal goals and expectations
  6. Method Transfer paradigms
  7. Investigations
  8. Review of FDA warning letters
  9. Case Study Exercise from current FDA Warning Letters
  10. Theoretical Case exercises
  11. Questions and Answers




Meet Your Instructor

Dr. Jay Nair,
Managing Partner - Analytical CMC Consulting LLC

Dr. Jay Nair, PhD, is a CMC Leader with 27+ years' experience in analytical and cross-functional CMC leadership roles in all phases of oncology and other drug development projects ranging from IND filing to commercialization, including (s)NDA/MAA and BLA filings. Jay is experienced with small molecule, generics and biologics (including bio-similars) with emphasis on early approvals. As a certified Project Management Professional, he has a passion for applying project management principles to Drug Development & Quality Control.

Most recently, Jay was Executive Director for biologics at Bristol-Myers Squibb (2013-2015) responsible for the overall management of Analytical R&D for industry-leading pipeline of novel biologics. Prior, Jay was Senior Director, Analytical Sciences for Global Branded R&D at Teva Pharmaceuticals (2006-2012) where he headed all Analytical Sciences functions including GLP/GMP release and stability testing for small molecule and biologic products from pre IND to NDA/BLA including life cycle management. Jay also was Director of Research for Baxter (2002-2006) directing R&D of Parenteral products at worldwide facilities including global development partners.

Jay's core competencies include Biologics (large molecules); Small molecule Development and Analytical Development, R&D executive management, Project/Program Management, Validation and Qualification, CAPA, Investigations, Drug/Product Development, CMC Expertise, Quality and Compliance and FDA & other agency negotiations.





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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

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  • Announcement article of the conference on the magazine and/or website.
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