Project management tools to improve productivity and compliance in Analytical laboratories

• 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

7. Defining the two basic focuses of Project Management Practices
1. Controlling the number of firefights & increasing productivity
2. Controlling and prioritizing compliance improvement
8. Initial establishment of historical trends
9. Establishment of a baseline lab productivity and compliance profile
10. Initial monitoring
1. Setting the goals
2. Trending
11. Risk Analysis as a tool
1. Setting expectations to Stakeholders
2. Setting internal goals and expectations
12. Method Transfer paradigms
13. Investigations
14. Review of FDA warning letters
15. Case Study Exercise from current FDA Warning Letters
16. Theoretical Case exercises
17. Questions and Answers

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.