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You have a sterility or Bioburden test failure - Webinar By ComplianceOnline Why Should You Attend: All sterile products require some level of sterility and bioburden testing during validation and then during routine production. What actions your company takes when this testing exhibits results that do not meet specifications can be critical from a regulatory and safety standpoint. You need to know what and how to investigate...more
Bringing Compliance to Design Control for Older Products - Webinar By ComplianceOnline Why Should You Attend:Many regulated companies have not brought their old products up to the new FDA standards and are not in compliance. This webinar defines the criteria to be used for medical products design history file remediation.For example companies should be compliant to 14971:2007. Design History Files need to be adjusted to meet the new standards. The FDA expects risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product. Each product needs to have a gap analysis to determine obsolescence or validate. It should also describe the risk acceptance criteria as well as roles and responsibilities of each member on the team.In this webinar, we will discuss practical steps you can follow to bring your product design history files up to date with the new standards.Areas Covered in the Seminar:Multi-functional team approach/responsibility.Set procedures and template to complete remediation for design history file of old products to meet the new standards.Gap analysis.Gathering of data to build the design...more
Three Facts About Selling Online Selling products online isn't rocket science, but most people fail because they ignore the three most important facts about creating a successful e-commerce store.Fact 1: Unique Products Sell BetterIf you're just selling what everyone else is selling, you'll have to compete with everyone else. While...more
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