Does the UDI Extension for Some Implantable Devices Apply to All UDI Requirements?

The extension for some implantable devices does not apply to all Unique Device Identification (UDI) requirements.  The extension only applies to the label requirement.  Requirements to collect, store, normalize, validate and submit data to the Global UDI database (GUDID) must be met by September 24, 2015.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Should Validation Services and Training be Included in a Request for Proposal?

It’s important to be very clear in a Request for Proposal (RFP).  If you want validation or training services, specify exactly what you are looking for in the request.  For example, some companies have validation staff, but may not have a validation leader.  You may want to specify that you only need a validation team leader.  If you will need training services, include who will need to be trained.  You may only need help training the trainers or you may need training for an entire department.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.

Does the UDI Extension for Some Implantable Devices Apply to All UDI Requirements?

The extension for some implantable devices does not apply to all Unique Device Identification (UDI) requirements.  The extension only applies to the label requirement.  Requirements to collect, store, normalize, validate and submit data to the Global UDI database (GUDID) must be met by September 24, 2015.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

When to Establish Requirements for New LIMS/Lab System?

It’s important to understand the capabilities of the new LIMS and develop a baseline of requirements at the beginning of the project.  It’s a good idea to have representatives from every department that will use the new LIMS participate in establishing the baseline of requirements, because departments within a company often have different requirements.  Kathleen Warner, Vice President of Project and Program Management at USDM Life Sciences says requirements for one particular LIMS project she worked on had to be revised four times because company representatives learned about new capabilities of the lab system during the project.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.

FDA Extends UDI Compliance Deadline for Some Medical Devices

The FDA’s Center for Devices and Radiological Health (CDRH) is granting a compliance extension of some of the UDI labeling requirements for some non-sterile implantable medical devices, which were otherwise subject to the September 24, 2105 compliance deadline.The new compliance deadline is September 24, 2016 for devices that meet ALL of the following criteria:

Compliance Deadline Extension Criteria

1. classified with primary product codes and regulations listed on the letter to implant labelers
2. single use implants, and
3. intended to be sterilized (or cleaned and sterilized) before use. Most of the devices that meet these three criteria are supplied non-sterile by the manufacturer

USDM Life Sciences will provide more details about the extension at a live webinar on January 15, 2015. USDM’s Jay Crowley, who had primary responsibility for the development and implementation of FDA’s UDI system will lead the presentation.

How Much Should a Project Manager Micromanage Life Sciences Projects?

Kathleen Warner, Vice President of Project and Program Management Services and Solutions says the amount of micromanagement on projects depends on the experience level of the team.  For example, if there is a senior subject matter expert with a good track record on the team for a short term project, micromanagement of the project is not usually necessary.  Warner says a project manager should focus on delegating and facilitating tasks instead.  However, some long term projects may require micromanaging on a daily basis when you run into problems or have an approaching deadline.

USDM Life Sciences Project and Program Management experts are the perfect fit to help guide, lead and support life sciences organizations’ mission-critical project and programs initiatives across highly regulated areas, where compliance, technology and business intersect, to attain desired business results. USDM’s Project and Program Management Services and Solutions team can provide all of the required services needed to successfully manage your projects, your programs and your portfolio with consistent and standardized methods, processes and principles.

How to Research LIMS Vendors Who Understand Pharmaceutical Regulations

If you have a Legacy LIMS system, talk to your Legacy vendor.  Another good method is to search the Internet for articles that discuss LIMS.  Do a search on the Internet for “top 10 LIMS vendors in regulatory environment.”  You will be able to see some lists of current LIMS vendors as well as articles that discuss LIMS vendors.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.