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Project Management
One & A Half-Day COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOP
Dates Available: December 1-2, 2009
Course Time: 8:30 a.m - 5:00 p.m.
Cost: $895.00 +GST
Location: 200 Consumers Road, Suite 200, Toronto, Ontario
Receive a Credit toward the Mini MBA, or Diploma program in QA/QC, Clinical Research, or Regulatory Affairs
Course Outline
- INTRODUCTION
- What is Project Management(definitions and misnomers)
- Tools Used
- Defining a Project
- Project scope & Objective setting
- Budget, Timeline, Quality
- The Team
- The Leader
- Getting Started
- Defining Project Scope
- Defining the Project Team
- Roles and responsibilities
- Communication
- Leadership
- Milestones and Durations
- Estimating resource requirements
- Timelines
- Dealing with Risk and Uncertainty
Case Study #1 (a) – building the project plan (*example to be used = optimization and registration batch mfg’g/preparation, stability and submission of an NDA)
- Just when you think you have it planned out
- Tracking Project Progress
- Understanding Constraints (…on…)
- Timeline, Budget, Resources
- Evaluating the Project Team and Performance
- Keeping Projects on Track
- Communication of Delays and Variances
Case Study #1 (b) – add complexity to project plan mapped in Case Study 1 (a); imposed date for NDA submission; reduction in available API to mfg), changes in resources
- Looking at the Big Picture
- Recognizing and identifying risk factors
- Managing Risk
- Preparing a risk management plan
(Case Study #2 – mapping new timeline with unknowns and predicted challenges, formulation development)
Communication & Leadership (* a focus on the soft skills)
- Encouraging Peak Performance
- Managing conflict
- Adaptation & Diversity
- Closing a Project
- Post Mortem on the project, the team and you
Distinguished Faculty
Jill Kapuscinski has over 19 years experience in the Pharmaceutical industry holding various positions within Research and Development, Project Management and Business Development. She has worked in the capacity as scientist developing a wide variety of pharmaceutical products at GlaxoSmithKline before turning to Project Management and Business Development at Patheon Inc. She has focused her career on research and development across all sectors remaining passionate about strong technical and communication skills and the development of teams and people. A graduate of Ryerson Polytechnic University Jill is a self-described builder.
While at GlaxoSmithKline (GSK) her 11 year career developed strong hands on experience in formulation and process development, optimization and evaluation of new liquid and solid dosage forms, CMC preparation and lifecycle management through the development of line extensions. Approximately 2 years focused on the commissioning of GSK’s new R&D pilot plant in Mississauga, development of a multi-level training program and GMP processes. In November 2000 Jill was seconded to the United Kingdom to support the inhalation product development team at GSK’s Ware facility and upon return to Canada focused on nasal spray formulation and device development and training programs within the R&D division.
Jill joined Patheon Inc in October 2001 in Pharmaceutical Development Services, Project Management at the corporate center in Mississauga before moving to the Whitby Operations site in March 2003. She held the position of Senior Project Manager, Project Management Unit Head and Associate Director, Project Management for two sites. Strong technical skills, project management and leadership was key to successfully growing the business unit from 4M to 13M USD in revenue by 2008. She has worked successfully through active project management of a diverse range of clients and projects, maintaining a focus on client service and development of a high performing team. In 2008, Jill was appointed Director, Business Management to focus on leadership and development of a business management team, commercial clientele and business contracts. She holds additional strategic roles as a member of the Site Leadership Team at the Whitby Operations site recognizing the importance of communication and development of long term plans to build for a successful future as well as instill a client focus culture across the organization.
Jill’s greatest assets are her strong communication, project management and presentation skills. She is a creative and passionate leader; developing people and supporting culture shifts across organizations. She enjoys coaching and developing people and seeing new ideas come to life and with her family participates in the not-for-profit organization Cottage Dreams giving families battling cancer an opportunity to enjoy the life of cottaging. She is also an active member of the Canadian Society of Pharmaceutical Sciences (CSPS) to bring greater awareness of the organization to the scientific community here in Canada.
Who Should Attend
This one & a half day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:
- Regulatory Affairs
- Clinical Research
- Quality Assurance
- Documentation and Technical Writing
- Product Submission
- Project Management
- Training
- Product Development
- Consultants
- Others who interact together to launch a product
CERTIFICATE OF ATTENDANCE AND COURSE MATERIAL
- All participants will receive a certificate of attendance upon completion of the course.
- The participants will be receiving specially prepared course manual.
COURSE LOCATION
AAPS Training Center
200 Consumers Road, Suite 200 , Toronto , Ontario , M2J 4R4
tel: 416-502-2277
www.aaps.ca
*Registration Fee Includes:
Presentation Materials, Luncheon, Refreshment and Free Parking
*Please indicate any special Dietary requirements when registering for the course
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