WEBINAR: Qualifications & Use of Contract Sterilization Services
Expired

  • March 6, 2019
    1:00 pm - 3:00 pm

Location

M QA W

Certification Areas

Sterilization technologies provide a critical service to the Pharmaceutical, Medical Device and OTC industries for sterilization, contamination control and material modification. The most common services available include radiation (Gamma/eBeam/X-ray), Ethylene Oxide (EO) gas and Steam.  

 

Due to the capital cost, high technical complexity and hazardous materials involved, these operations are often outsourced to contract service providers. Any organization using these services needs to understand the critical aspects of how these operations maintain GMP compliance. It is also important to understand what to look for during vendor qualification.  

 

This webinar is designed to provide guidance to assist with understanding the current resources and technologies available, benefits and challenges of each method and international standards (AAMI and ISO). Emerging technologies such as X-ray and Sustainable Ethylene Oxide (EO) will also be explored.

 

The course emphasises practical issues such as:

1. Modality Selection

2. Vendor selection, qualification and management

3. Validation

4. Process Controls

 

Who should attend:

 

This webinar is targeted at personnel from Quality Assurance, Production, Quality Control and Regulatory Affairs responsible for the compliance of sterile Drugs, Medical Devices or Medicinal Cannabis processed at a Contract Sterilization Service.

 

Course Leader:

Gordon R. Dobrindt, B. Sc., ASQ CQA

 

Gordon has spent 13 years various Quality Assurance roles ranging from the importation and distribution of OTC products to the production of Rx Drug products to his current role in Quality management at a contract sterilization facility. Gordon completed his undergraduate studies at the University of Guelph, in additional he has completed the PSG QA Certification program and the Industrial Pharmaceutical Technology program at Seneca College.



Student Ticket: $100.00 Sold Out
Basic Member Ticket: $210.00 Sold Out
Pro/Pro Plus Member Ticket: $180.00 Sold Out