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Thursday September 2, 2010
Mission & Values

International Pharmaceutical Academy (IPA) is a progressive Canadian organization dedicated to be the primary provider of Quality Education and Training for the Pharmaceutical, Medical Devices, Biologics, Cosmetics, and Allied Industries.

We present experts from industry, academia and government agencies. Providing the best in educational instruction in short course formats together with carefully orchestrated workshops.

IPA Future Events - (Please click here for a full listing of our events)

Cold Chain & Logistics Management

November 2-3, 2010 - Somerset, NJ

Preliminary Outline An Important Two-Day Conference with Interactive Exercise and Case Studies on:

  • IATA Chapter 17 Revised Regulations for Temperature Sensitive Healthcare Products
  • Underlining European Regulatory Expectations for Temperature Sensitive products
  • USP Chapter 1079: Industry Feed Back and Next Steps
  • Quality Management for Temperature Monitoring – A Regulatory Perspective
  • Temperature Monitoring During Warehousing and Transportation
  • Implementing Cold Chain Controls from Manufacturing to Distribution for Cold Chain Pharmaceutical Products
  • "Last Mile" Related Temperature Monitoring Challenges
  • International Focus: Import/Export Shipping Challenges and Best Practices
  • Protecting Pharmaceutical Shipments in both In-Transit & Warehouse Storage
  • Risk-Based Approaches for Effective Cold Chain Management
  • System to Maintain Cold Chain Integrity  
  • Case Study: Thermal Property Analysis of Product Payload for Shipper Qualifications
  • Temperature Mapping Trade Lanes, Approach and Results to the Study: Benefits and use of the data
  • Successful Selection and Implementation of Temperature Controlled Containers
  • Potential Impact on Engineered Packaging and Temperature-Controlled ULDs Transported via Composite-Based Aircraft.
  • Airline cargo capacity challenges in the future
  • Reusing Passive Shippers – Considering the Thermal, Environmental and Economic Impact to your Cold Chain Management Process

 

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Combating Counterfeit Medicines

November 18-19, 2010 - Washington, DC

Program Outline

  • Recent examples of counterfeit pharmaceuticals (case studies)
  • Combating pharmaceutical crime over the internet – Enforcement and public awareness
  • Anti-counterfeiting enforcement programs in the US
  • Developing working relationships with US law enforcement authorities
  • The RCMP Mandate and Canadian legislation to combat pharmaceutical crime
  • Regulatory oversight and enforcement: examples from selected countries in Mekong region
  • Building an effective in-house anti-counterfeiting program
  • Technologies, prevention strategies and how effective they are
  • Challenges and opportunities of implementing  anti-counterfeiting serialization systems
  • Basic testing techniques to detect counterfeit medicines used in the field and analytical methods for verification
  • Advanced technologies for screening of counterfeit biologics    
  • How Public Private Partnerships can help to combat unsafe medicines
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Analysis of Metal Impurities According to Proposed USP Chapters
Are You Ready for the USP <231> Heavy Metals Transition to the Proposed USP Chapters <232>, <233>, and <2232>?

October 5-6, 2010 - Philadelphia, PA

COURSE OUTLINE:

  • Scope And Context Of USP’s New Chapters On Elemental Impurities (<232>, <2232> And <233>)
  • The New USP Chapters – Understanding The Requirements And The Technology Available To Meet Them
  • USP'S Elemental Impurities Initiative Current Status
  • USP Proposed Heavy Metal Toxicity Limits
  • Review Of USP Chapter <231> On Heavy Metals
  • Chapter <232> Elemental Impurities - Limits, Harmonization
  • Chapter <233> Elemental Impurities – Procedures & Acceptance Criteria
  • Procedures And Acceptance Criteria For Elemental Impurity Analysis
  • Checklist: Elemental Impurity Analysis According To USP <233>
  • Modern Methods For Trace Metal Analysis In Pharmaceutical And Dietary Supplement Applications
  • Necessary Sops
  • Trace Metal Analytical Instrument Qualification
  • Method Development And Validation Strategies Associated With Elemental Impurity Determinations
  • Use Of GFAA, ICP-OES, And ICP-MS For The New USP Chapters
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GMP Update 2010

Global Perspectives for Pharmaceutical, Biopharmaceutical and Allied Industries
Les perspectives mondiales concernant les médicaments pharmaceutiques, biopharmaceutiques et industries connexes


September 28-29, 2010 | Montreal - Canada
Le 28-29 septembre, 2010 | Montréal-Canada

Course Overview

The greatest gathering of GMP experts from across the globe addressing the current challenges of GMPs
Le plus grand rassemblement d'experts mondiaux sur les BPF, abordant les défis actuels reliés aux BPF

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Advances and Efficiencies in Stability Testing for the Pharmaceutical & BioTech Industry

October 19-20, 2010 - Montreal,Cananda

Program Outline:

  • Stability Testing - Overview of ICH guidance relevant to stability testing
  • Stability Storage Operations
    • Storage Chambers
    • Stability Chambers Life Cycle
  • Requirements for Stability in Zone III and IV Countries
  • Dossier Requirements for Setting Specifications
    • Setting Specifications during Development Phase
    • Specifications for APIs: Evaluating Organic Impurities
    • Specifications in Stability Testing
  • Conducting Forced Degradation Studies
  • Stability Testing of Biological and Biotechnological Products
  • Recent Developments in the WHO Vaccine Stability Guidance – Key Definitions
  • Development of Analytical Methods and Setting of Rational Specifications for Biotechnological Products
  • Stability-Indicating Profile for Biotechnology Products: Considerations for Development of Stability Testing Program for Biopharmaceuticals
  • Evaluation of Stability Results – Statistical Considerations
    • OOS & OOT Data - Assessing Outliers
  • Submitting Stability Data – The CTD-Structure
  • Post-marketing Stability Testing

and more...

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What's new?




Health Canada Informs Pregnant and Breastfeeding Women Not to Take Vitamin Maxum Matragen and/or Maxum Multi Vite Supplements

Health Canada is advising expectant mothers and breastfeeding women not to take the vitamin-mineral supplements Maxum Matragen or Maxum Multi-Vite by Seroyal International Inc. Maxum Multi-Vite has been approved as a vitamin-mineral supplement for only the general public but lacks the required cautionary statement on the label regarding pregnant and/or breast feeding women. The product Maxum Matragen is being promoted by the company as a prenatal supplement; however, neither product has been authorized for sale by Health Canada for use by women who are pregnant or breastfeeding. Read More

A Small Number of Bottles of the Antibiotic Rofact® (Rifampin) May Contain a Different Drug

Health Canada is warning consumers that there is a small possibility that some bottles of one lot of Rofact® (rifampin), an antibiotic used to treat tuberculosis (TB) and some other infections, may contain the drug clonazepam instead of the antibiotic rifampin. The affected lot number of Rofact® is 8K5467, and the Drug Identification Number (DIN) is 00343617. Clonazepam is an anti-epileptic medication and has sedating properties. The manufacturer, Valeant Canada, is initiating a recall to the retail level. Read More

Update - Health Canada Reviewing Hydroxycut Products in light of U.S. Advisory

Health Canada is updating Canadians about Hydroxycut products. On May 1, 2009, the U.S. Food and Drug Administration (FDA) issued a public warning regarding certain Hydroxycut products. The FDA is advising U.S. consumers to stop using Hydroxycut products as there have been reports of liver injuries potentially associated with this product in the United States. Read More

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