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« Thursday August 12, 2010 »
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Supplier Evaluation and Assessment Program: How to meet FDA QSR and ISO 13485 requirements in a cost effective manner Start: 08/12/2010 9:00 am End: 08/12/2010 10:30 am Detailed review the QSR and ISO requirements for supplier evaluation and assessment, and cost efficient options to many of the common practices. Description: Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this.Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in complliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices. Areas Covered in the Seminar : QSR and ISO 13485 requirements for supplier selection and assessment How to qualify new suppliers in a cost efficient manner How to assess current suppliers in a cost efficient manner How to perform supplier-related corrective action Minimum documentation requirements for supplier qualification, assessment, and related corrective action Note: Use this Promo Code(102165) to avail Discount of 10% on LIVE Purchase. Developing an ethylene oxide (EO) sterilization process for a product with limitations Start: 08/12/2010 10:00 am End: 08/12/2010 11:30 am This EO sterilization training Webinar will discuss how to modify EO sterilization process for complicated medical products which are sensitive to moisture, temperature, vacuum changes. Why Should You Attend: Medical products have become more complicated with many containing computer chips, batteries, antibiotics, or other items/materials that make sterilization a significant challenge. These products that present difficult challenges to the EO sterilization process may include those products that have sensitivity to temperature, have moisture limitations, are sensitive to vacuum changes (either level or rate), retain EO, have batteries, or a combination of these factors. Developing a sterilization process presents a challenge but in virtually all cases a process can be developed that meets the requirement to have a sterile functional product. Areas Covered in the Seminar : How to limit moisture exposure. Running a low temperature process. How to address vacuum sensitivity. Parameter inter-relationships. How to reduce EO residuals. Testing outside of the sterilization facility. Considerations for validation and routine processing. Note: Use this Promo Code(102165) to avail Discount of 10% on LIVE Purchase.