What is Project Management in Pharmaceutical Industry Seminar

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

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Until December 15, Early Bird Price: $1,295.00

From December 16 to January 13, Regular Price: $1,495.00

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Speaker and Presenter Information

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.