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Temperature Excursions

Impact of Severe Weather Conditions on Biological Products

Late last month the FDA CBER (Consumer Affairs Branch) issued an advisor notice to interested persons containing information related to the storage and use of temperature sensitive biological products that have been involved in a temporary electrical power failure, or flood conditions.
By Peter Norton

Author: Peter Norton

Peter Norton is a senior logistics and supply chain manager who is a consultant hired by clients in both the life science industry, and the food supply industry. Peter has extensive experience in both the domestic US and global markets specifically in the areas of cold chain management and security as this relates to the pharmaceutical industry to insure drugs that are supplied to the patient are at the required stability levels and peak efficacy.

View Peter's profile

Peter's Recent Articles

Imagine the Quality advantage of Drug Serialization compliance linked with Cold Chain monitoring?

Block Chain and The Supply Chain – Produce and/or Life Sciences

Produce Quality Code can offer a better indicator to Shelf Life

Transit Data Recorders move from PC to Mobile

Risk Assessment and Mitigation Planning - Are you covered?

DeltaTrak Debuts New Mini PDF In-Transit Logger

Are you truly 21CFR Part11 compliant?

Remote Wireless Refrigerator Monitoring

FSMA - are you prepared?

Smart Solutions for the Last Mile, or Patient Mile!

The Importance of being up to date on regulatory compliance - Globally!

Cloud Computing & Visibility Solutions

DeltaTrak Cuts Costs in Cold Chain Logistics

DeltaTrak's 75-Day USB In Transit Export Logger

The Global Importance of the Chinese FDA GSP Regulations

How Do You Rate or Qualify Your Vendors and Suppliers?

Big Data - Who Controls and what do you want to see?

Beyond the Last Mile - Who controls this?

IQPC 2014 (September 29th to October 3rd) Review of Events

Serialization - Track and Trace - Don't forget the cold chain

Prep for Flu Season: Temperature Monitoring and DeltaTrak’s Vaccine Data Logger with Glycol Bottle

The reports are in: - "What causes most Cold Chain monitoring failures"

Impact of Severe Weather Conditions on Biological Products

CDC Vaccines For Children (VFC) and Immunization Programs - US State Level

FDA - Includes Drugs and Food regulation

GDP Compliance to meet new regulation introduced within the EU in March-2013

Time Out of Refrigeration (TOR) considerations

MKT - To be used, or not to be used?

Risk Assessment and Risk Mitigation planning Webinar
MKT - To be used, or not to be used?

I am sure that most of the Blog readers are familiar with MKT (Mean Kinetic Temperature) calculations, but just in case you are not, MKT is defined by the United States Pharmacopeia as:
By Peter Norton

Author: Peter Norton

Peter Norton is a senior logistics and supply chain manager who is a consultant hired by clients in both the life science industry, and the food supply industry. Peter has extensive experience in both the domestic US and global markets specifically in the areas of cold chain management and security as this relates to the pharmaceutical industry to insure drugs that are supplied to the patient are at the required stability levels and peak efficacy.

View Peter's profile

Peter's Recent Articles

Imagine the Quality advantage of Drug Serialization compliance linked with Cold Chain monitoring?

Block Chain and The Supply Chain – Produce and/or Life Sciences

Produce Quality Code can offer a better indicator to Shelf Life

Transit Data Recorders move from PC to Mobile

Risk Assessment and Mitigation Planning - Are you covered?

DeltaTrak Debuts New Mini PDF In-Transit Logger

Are you truly 21CFR Part11 compliant?

Remote Wireless Refrigerator Monitoring

FSMA - are you prepared?

Smart Solutions for the Last Mile, or Patient Mile!

The Importance of being up to date on regulatory compliance - Globally!

Cloud Computing & Visibility Solutions

DeltaTrak Cuts Costs in Cold Chain Logistics

DeltaTrak's 75-Day USB In Transit Export Logger

The Global Importance of the Chinese FDA GSP Regulations

How Do You Rate or Qualify Your Vendors and Suppliers?

Big Data - Who Controls and what do you want to see?

Beyond the Last Mile - Who controls this?

IQPC 2014 (September 29th to October 3rd) Review of Events

Serialization - Track and Trace - Don't forget the cold chain

Prep for Flu Season: Temperature Monitoring and DeltaTrak’s Vaccine Data Logger with Glycol Bottle

The reports are in: - "What causes most Cold Chain monitoring failures"

Impact of Severe Weather Conditions on Biological Products

CDC Vaccines For Children (VFC) and Immunization Programs - US State Level

FDA - Includes Drugs and Food regulation

GDP Compliance to meet new regulation introduced within the EU in March-2013

Time Out of Refrigeration (TOR) considerations

MKT - To be used, or not to be used?

Risk Assessment and Risk Mitigation planning Webinar

World Health Organization Product Development Videos DeltaTrust Professional Services Soap Dispenser Rebate FlashLink Multi-Use-Logger Chinese FDA Mini Pdf Temperature Thermometer USB Data Logger Transporation Food Safety Modernization Act IPPE Imports Walmart Smartphone Monitoring Risk Mitigation

RTL-Prime 3G Solutions

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