Contract Management for Vendors of FDA-Regulated Systems

1
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
2
Instructor Profile

• Carolyn Troiano has more than
  25 years of experience in computer system
  validation in the pharmaceutical, medical device,
  animal health and other FDA-regulated industries.
  She is currently the ERP (Enterprise Resource
  Planning) Program Manager at the City of
  Richmond, VA, where she is overseeing the
  implementation of a large, complex system that
  spans more than 40 agencies and is used by more
  than 4,000 City employees.Prior to working for
  the City, Carolyn worked directly, or on a
  consulting basis, for many of the larger
  pharmaceutical companies in the US and Europe.
  Carolyn was responsible for computer system
  validation across all regulated functions at
  Wyeth Laboratories, now part of Pfizer. She
  developed validation programs and strategies back
  in the mid-1980s, when the first FDA guidebook
  was published on the subject. While at Wyeth,
  Carolyn co-authored 21 CFR Part 11, or the FDAs
  electronic record/electronic signature (ER/ES)
  regulation as part of an FDA/Industry
  partnership.
• She has taught ER/ES compliance, along
  with computer system validation and risk
  management/compliance at a number of Fortune 100
  pharmaceutical, medical device and other
  regulated firms. Her experience includes work
  with laboratory automation systems (LAS),
  laboratory information management systems (LIMS),
  clinical data systems (CDS) and many other
  FDA-regulated systems involved in the
  manufacturing, testing and distribution of
  pharmaceutical and biological products.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
3
Why Should you Attend

• The attendee will learn how to
  develop a standard approach to managing vendors
  who provide products and services, consultants
  and contractors in a manner that complies with
  FDA guidelines for computer systems. Some of
  these people will be new to the concept of
  validation and FDA regulation, and will have to
  be coached on how to follow any necessary
  procedures required for compliance. This is true
  for vendors who engage companies in the Tobacco
  industry, where regulations are emerging, but it
  is also true in pharmaceutical and related
  industries where vendors are new to this market
  and may not have the skills or training required.
  It's important to look at what are some of the
  threats and challenges, and what methods you can
  use to mitigate these. 
• There is an enormous body of documentation
  and information available that can be
  overwhelming. This course will provide a
  condensed overview of the practices that deliver
  the best results by directing the attendees to
  the most critical and cost-effective techniques
  and tools available to assure compliance when
  managing vendor-related activities. 

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
4
Who can Benefit

• Information technology
  analysts, project managers, organizational change
  managers, business process engineers, QC/QA
  managers and analysts, clinical data managers and
  scientists, analytical chemists, compliance
  managers, lab managers, automation analysts,
  computer system validation specialists, GxP
  training specialists, business stakeh olders and
  individuals who are responsible for computer
  system validation planning, execution, testing,
  reporting, compliance, and audit. This webinar
  will also benefit any consultants, contractors or
  vendors providing products and services to the
  life sciences industries and who are involved in
  computer system implementation, validation and
  compliance. 

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
5

• Live Session - How it works
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf format will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA sessions via chat
• Please let us know your thoughts and views at the
  end of webinar, your valuable feedback will help
  us improve
• Get certification of attendance.

• Recorded Session - How it works
• A link will be provided to you upon purchase of
  the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf format will be
  mailed to you
• Get certification of attendance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
6
About OnlineCompliancePanel

• Online Compliance Panel creates and
  delivers comprehensive industry relevant training
  sessions. These sessions are simple, interactive
  and cost effective. We are a predominantly web
  based information exchange forum. Live
  interactions on compliance training make the
  process holistic and effective. Online Compliance
  Panel largely emphasizes in offering regulatory
  compliance training to compliance professionals
  on varied topics. These primarily include risk
  management, quality management, corporate
  compliance and other regulatory compliances. Some
  of our primary areas of focus include advancement
  and updates in regulatory compliance, best
  practices and market trends.
• For the more information about the webinar
  kindly visit the link given
• http//bit.ly/contractmgnt

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com