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Location: Building 535Phone: (909) 607-9864
Email: diana_bartlett[at symbol]kgi.edu
Regulatory Management Series
Irvine, CA
No longer a "niche" function, regulatory affairs impacts all parts of any bioscience company large or small.
Enhance your regulatory affairs knowledge...become current on the latest requirements from the FDA and other bodies... become more strategic in management of this critical area. KGI's Regulatory Management Series (RMS) consists of five information-rich days - each of which is devoted to a specific regulatory area.
Regulatory compliance is a significant investment by any life science company. Not only do clinical trials take almost a decade to complete at a cost of hundreds of millions of dollars, but armies of regulatory and clinical affairs professionals devote themselves to the development, implementation, and analysis of trial results.
What's more, regulatory body oversight has increased, reflected in, for example, the budget of the US FDA which increased from $1.3 billion in the late 1990s to $3.2 billion in 2009.
FDA Law and Regulatory Affairs:
- Development of productive relationships with regulatory bodies takes more than an ability to conduct clinical trials and prepare documents. Strategy, relationships, context, and a variety of other "higher order" thinking are required.
- Overview of FDA and regulatory affairs including current status of FDA laws and FDA Modernization acts
- Product development phases: pre-clinical to reimbursement and life cycle management
- FDA regulatory approval process from design input stage through submission: BLA, 510(k) documentation and post-market approval requirements
- FDA interactions with applicants: enforcement, compliance, relationship management
Quality Management:
During the last several years, the FDA has issued numerous observations and warning letters to pharmaceutical and biotechnology companies for not having adequate quality systems in place. Every company needs quality systems, even if it outsources some or all cGMP activities.
- Review and compare industry guidance from the FDA, ICH Q10, and cGMP requirements
- Evaluate leading industry quality systems such as the Six-System Inspection Model
- How to implement a pharmaceutical quality system
- Gap analysis and system/process reviews
Risk Management:
Risk of any form presents a significant decision-making conundrum to the organization - but especially to life science companies that rely heavily on future outcomes to grow their businesses. Risk in the regulatory arena is especially challenging and requires a proactive approach.
- Overview of enterprise risk management and the background to FDA's developing interest in risk management
- Systems approach to risk management, explains the FDA's requirements, and addresses the issue of implementation
- Risk acceptance - when can risk be low enough and acceptable? how management must formally go about accepting risk
- Risk assessment and introduces a framework for using risk assessment tools
FDA Medical Devices:
As regulatory scrutiny increases around the globe, the medical device industry is experiencing significant pressure from enhanced requirements and expectations. An understanding of the new world of medical device regulation is necessary for any successful medical device manufacturer.
- Preamble to and detailed review of the Quality System Regulation
- Medical device clinical trials: clinical outcome studies, design control, post market surveillance
- Regulatory Requirements and FDA expectations
- Quality System Inspection Technique
This course is intended to fulfill General GMP training requirements of Title 21, Code of Federal Regulations, Part 820, Subpart B * ISO13485:2003/9001:2000:6.2.2
FDA Manufacturing:
Over the past 12-18 months, increased regulatory and lawmaker scrutiny has focused on manufacturing and operations. Several high profile plant closures have occurred, costing companies many millions of dollars. New uncertainty emphasizes the need for organizations to be thoroughly knowledgeable about FDA manufacturing.
- FDA oversight of later stage efforts including small molecule, biologics, and contract manufacturing
- How the FDA approaches supply chain vs. commercialization
- Fill...finish...packaging requirements
- Distribution and customer service
Download Schedule
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Location:
University of La Verne
Orange County Regional Campus
2855 Michelle Drive, Suite 250
Irvine, CA 92606
Fee:
Customize your Keck CE week. You choose which days (topics) you attend, ensuring your time is being optimized.
Program Fees:
5 days - 2,500.00 ($250 savings)
4 days - 2,100.00 ($100 savings)
3 days - 1,575.00 ($75 savings)
2 days - 1,100.00
1 day - 550.00
Program fee is inclusive of all course materials. Continental Breakfast, lunch and refreshments are provided.
Group discounts are available!!
For More Information:
Diana Bartlett
Diana.Bartlett[at symbol]kgi.edu
909.607.9864