Course "Risk Based Project Management for the Life Sciences Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
Project management is a discipline that can be applied to all industries. In the pharmaceutical industry, project management is the key to addressing the unique regulatory, compliance and quality related needs of the industry. The process of clinical research and drug development, coupled with the critical issue of time to market, can use project management techniques to effectively apply scheduling, risk management, and comprehensive quality assurance and control to the process of bringing a drug to market in a safe, effective & cost-efficient way
Every industry has different "stress points"-those points that are most critical to the specific product or service being delivered. The most typical stress points are schedule, cost, and quality. Depending on the project, one (sometimes more) of these stress points directly affects that company's profit, thereby making that point absolutely critical to the success of the product, and the company delivering it. In the pharmaceutical industry, the most important stress point is quality. For example, each year at least one drug company experiences a recall of one of their drugs, lawsuits from their customers or lawsuits from their competitors. Poor quality in this industry can literally be a matter of life and death, in its worst cases. Being the first to bring a product to market is also critical, though the course of drug development is unpredictable.
Because of the risks involved in the pharmaceutical industry, due diligence is of the utmost importance in terms of quality control measures. So these competing priorities-quality and time to market-must be well managed through careful process in order to reduce the risks inherent in this industry. Another current challenge for pharmaceutical companies is the pressure they are under to increase their productivity, as the number of new products reaching the market has been on the decline over the past few years. This productivity decline has led many to believe that the industry is in need of a new and better approach in its management of clinical research, drug development, and product delivery. The two key challenges in the pharmaceutical industry are quality and schedule, both of which are directly addressed by the tools and techniques used in project management
The Seminar:
This hands-on seminar provides good practices for project management for a wide variety of project types within the pharmaceutical industry. The Seminar considers how appropriate tools and techniques can support and promote good project management practices and aims to help in sharing of these good practices to facilitate their use within the pharmaceutical industry.
This Seminar aims to:
provide specific guidance on project management in the pharmaceutical industry
provide a resource for Project Managers and other professionals who are involved in projects in the pharmaceutical industry
provide a link to project management bodies of knowledge for industries other than the pharmaceutical industry
The Seminar is specific to Project Management within the global pharmaceutical industry and projects specific to that industry. The concepts, principles, approaches and tools will include product lifecycle as described in ICH Q10, as well as projects for facilities, engineering and IT
Who Should Attend:
VP of IT
Director of IT
Quality Managers
Project Managers (for CSV / IT)
Validation Specialists
Database Administrators
System Administrators
Directors / Senior Directors of Discovery
Directors / Senior Directors of Development
Directors / Senior Directors of Commercialization
Document Managers
Training Managers
Regulators
Vendors
Suppliers
Outsource Service Providers
Industries:
Pharmaceuticals
Biotech
Medical Device
Radiological Health
Blood Products
Companion Animals
Food
Cosmetics
Tobacco
Academia
Agenda:
Day 1 Schedule
Lecture 1: Introduction and Background
Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss)
Background
Industry Context
Key Concepts
Lecture 2: People Management
Introduction
The Project Manager
Senior Stakeholders
The Project Team
Consultants & Contractors
Knowledge Management
Language, Culture & Communication
Lecture 3: Risk Management
Introduction to Risk Management
Pharmaceutical Risk Types
Pharmaceutical Quality Risk Management
Integrated Project Risk Management
Lecture 4: Project Initiation
Introduction
The Importance of Good Front End Definition - a Cat Story
Stage Gate Project Approval Process
Stage 1 - Project Feasibility - Is this a Good Idea?
Stage 2 - Project Conceptual Development - Identifying the Best Option
Lecture 5: Project Delivery Planning
Project Sponsor
Project Scope
Project Schedule
Project Cost
Project Controls
Project Team
Communication Plan
Design Management Strategy
Technology Strategy
Procurement Plan
Implementation Plan
Testing and Commissioning Strategy
Project Startup Strategy
Project Close-Out & Handover Strategy
Completion of Project Delivery Planning
Day 2 Schedule
Lecture 6: Design, Planning & Delivery
Feasibility Stage
Conceptual Development Stage
Budget & Schedule Objectives
Project Delivery Planning
Detailed Design Activities
Exercise
Completion of Design
Lecture 7: Implementation: Procurement
Strategy
Planning
Delivery
Exercise
Procurement Completion
Lecture 8: Implementation
Implementation Input
Pre-Implementation
Delivery
Exercise
Implementation Completion
Lecture 9: Testing & Commissioning
Testing Prerequisites
Delivery of Testing Phase
Exercise
Testing & Commissioning Completion
Lecture 10: Project Closeout
Handover Activities
Financial & Contractual Closeout
Knowledge Transfer
Closeout Checklist
Quiz: Jeopardy!!!!
Project Management in the Pharmaceutical Industry
Speaker:
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx. Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.
Location: San Diego, CA Date: January 15th & 16th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA
Price:
Price: $1,295.00 (Seminar Fee for One Delegate)
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