Registration for these Training Workshops includes Full Access to the Expo and Plenary Sessions
You may choose one or more workshops.

Workshop A 12:00-2:00 (Lunch Included)

Registration Closed (at capacity).  You may sign up as waiting list only during event registration.

Change Management in Pharmaceutical Manufacturing
(Courtesy of Mercer Institute of Management & Training)
Michael Falkow, the Lancer Group 

You will learn the roles in sponsoring successful changes.  We will present change management and some common sponsor pitfalls.  This is directed both for persons who are dealing with change management issues for the first time and for more experienced persons who want to review how they managed their change management experiences.  You will also learn the procedure for a system and description of the overall approach to documenting, assessing impact and approving changes to methods, processes, controlled documents, instruments and equipment.

Outline:
•    The value of change control
•    Role in sponsoring successful change control
•    Assessment of key leadership/sponsorship factors
•    The change control process
•    The quality system approach to change management

Workshop B 12:30-2:30 (Lunch Included)

Registration Closed (at capacity).  You may sign up as waiting list only during event registration.

The Key Role of Project Management
(Courtesy of the Project Management Institute, New Jersey Chapter)
Michael Sarachman, Program Manager, USDM Life Sciences
Moderator: Dalfoni Banerjee, Consultant & CEO, 3Sixty Pharma Solutions, LLC

Biopharma companies spend significant time and resources developing new therapies. Once these therapies have been approved, the challenge of bringing these products to market becomes the next organizational goal. This can only be accomplished through collaboration across functional, organizational and physical boundaries. Project management tools and methods present the opportunity for biopharmaceutical companies to accelerate this process, bringing new therapies to market more rapidly, concisely and efficiently.

Project management methods and tools share many characteristics across industries. Biopharmaceutical practitioners need tools and processes that will enable them to deliver on management, healthcare providers and patient expectations. This session will examine project management practices that have a track record of enabling successful project execution, as well as tools and methods that are worth your time, and those that may not be worth the hype.

Outline: 

  • Successful Cross-Industry Project Management Methods
  • Methods that deliver on management, healthcare providers, and patient expectations
  • PM Methods BioPharma Should Avoid

Workshop C 2:30-4:30

Registration Closed (at capacity).  You may sign up as waiting list only during event registration.

Preparing for an FDA Inspection
(Courtesy of Mercer Institute of Management & Training)
Michael Falkow, the Lancer Group

You will learn the roles of a company in preparing for an FDA inspection and actions during an FDA inspection (both your company and the FDA).  You will also learn the Establishment Inspection Report (EIR) response procedure, some common inspection findings and common inspection follow-up actions.  How to respond to a list of inspectional observations (FD Form-483) will also be presented.

Outline:
•    Why FDA inspections are performed
•    The different types of FDA inspections
•    Overview of the inspection process
•    How to efficiently prepare for and perform during an inspection
•    Inspection report response procedures
•    Common inspection observations


Subject to Change - Updated Sept 27, 2016