Lot Disposition; Clinical vs. Commercial – FDA, EMA, ICH Regulations & Guidance
Live, Interactive Training Webinar
Date: July 10, 2013
Time: 1:00pm - 3:00pm ET
Instructor: Peter Calcott Ph.D.
Click Here to Register for this Interactive, Live Webinar
Disposition and release of materials from plants, whether they be your own facilities or those of your contract manufacturers, is a key step in the process of manufacture of product to fuel your clinical trial or your commercial sales and marketing groups. There is always continuous pressure to release materials earlier but this must be weighed against the risks of making a rash or wrong decision in the disposition process. A poor decision can result in Field Alerts or Biological Deviation Reports or even recalls. With the increased vigilance of the agencies worldwide and the tightening requirements, it is important that your processes be efficient, compliant yet efficient and flexible to meet these apparently opposing forces. Even the most robust system can always see opportunity for improvement in speed and decreased risk if the correct questions are posed and then answered effectively. Based on warning letters in 2011, many companies still run foul of the law in their processes.
This live training webinar will provide valuable information on the requirements for lot disposition as defined by the regulations in USA, Canada and the EU. This will enable you to see how successful companies can translate these requirements into workable processes that are compliant with the regulations and yet efficient from a business perspective. Elements of risk management will be discussed as they pertain to development and execution of a system for lot disposition for clinical as well as commercial products for products manufactured within your own plants as well as those manufactured in your contract manufacturer's facilities. The webinar will present some metrics that can be put into place to measure your performance versus expectations which will set you on the road to continuous improvement. With this information you will be able to benchmark against some successful companies. You will also see how companies run foul of the agencies resulting in warning letters and how from this information you will be able to assure that you do not suffer the same fate.
Learning Benefits:
-The requirements for lot disposition.
-What regulations govern lot disposition.
-How to assemble and review the raw data and information and make rational decisions.
-How to incorporate risk management into the disposition process so you can focus your resources in the most vulnerable areas.
-The different challenges and how to manage them with clinical trial materials versus commercial products.
-What the agencies expect from you to convince them you are in compliance and in control.
-How to manage contract manufacturers and the release of materials.
-Where companies go wrong and get into regulatory hot water and how to avoid it yourself.
Regulations that will be Covered:
Each country has its own specific sets of regulations. Below are citations from ICH and examples of regulations that are applicable to the inspection and response processes and philosophy:
Code of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USA.
EMA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU.
International Conference on Harmonization Quality Series Q1 through Q10 for USA, EU, Japan and other countries with an emphasis on ICH Q7a.
Webinar outline and time breakdown:
Date:July 10, 2013
Time* Activity
| 12:45 PM | Log In Period | |
| 1:00 PM | Introduction | |
| 1:10 PM | The elements of disposition of materials, | |
| The regulations governing and controlling lot disposition, | ||
| How to compile and review data and information, | ||
| Making risk based decisions - balancing commercial and compliance issues, | ||
| Understanding what to delegate and what to control, | ||
| 2:00 PM | Break | |
| 2:10 PM | Certificate of Analysis and Certificate of Compliance, | |
| Dispositioning materials for clinical versus commerce, | ||
| Metrics associated with the disposition process, | ||
| Managing Contract manufacturers and releasing materials, | ||
| Where companies go wrong and how to avoid their problems, | ||
| Conclusions, | ||
| 3:00 PM | Live Questions & Discussion |
*Please note all times are Eastern Time
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Senior management
- Quality Assurance personnel and management
- Quality Control personnel and management
- Compliance auditors and management
- Manufacturing management and scientists
- Supply Chain and Logistics managers
- Regulatory Affairs Professionals
- Project Managers working in the CMC arena