Thursday, March 19, 2015

GCP Investigators: Do Regulations Require a CV to be Periodically Updated?

FDA does not require updates to CVs. Initial submission of documentation of training and experience on a CV is adequate. However, a sponsor may require CV updates. USDM Life Sciences recommends you adhere to sponsor requirements that are provided during the trial.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

Wednesday, March 18, 2015

Does the UDI Extension for Some Implantable Devices Apply to Implants Distributed in Sterile Form?

The Unique Device Identification (UDI) extension for some implantable devices only applies to devices distributed that are intended to be taken out of their package and sterilized before use, for example sets, trays and caddies.  Implants that remain in their sterile packing (class II and II) until use still have their original compliance deadlines.

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.

Monday, March 16, 2015

Does FDA Require the Investigator to Complete an FDA 1572 for Conducting Clinical Investigations of a Medical Device?

For clinical investigations of medical devices, an FDA 1572 is not required.  However, an investigator agreement is required for clinical investigation of medical devices.  An investigator agreement is not a specific form, it’s an agreement of the PI to conduct the trial according to regulations.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

Friday, March 13, 2015

Does the UDI Extension for Some Implantable Devices Apply to All Class II (FDASIA) Devices?

The extension for some implantable devices does not apply to all class II (FDASIA) medical devices.  The extension only applies to devices that are classified as FDASIA implants and distributed non-sterile.  It’s a limited subset of all FDASIA devices that have been granted this label extension to 2016.

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.

Thursday, March 12, 2015

Is There a Checklist for GCP Audits?

There are a number of GCP audit checklists, some of them are available for free online.  An Internet search for “GCP audit checklists” will provide you with many checklists to choose from.  The auditors at USDM Life Sciences recommend including a checklist as part of your quality assurance process – don’t wait until you get an audit notice to prepare.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

Wednesday, March 11, 2015

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.

Monday, March 9, 2015

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.