Dr. D is going to share some not so earth-shattering news with the readers. If an activity or event is not documented in writing, in the eyes of FDA (and…
Dr. D is going to share some not so earth-shattering news with the readers. If an activity or event is not documented in writing, in the eyes of FDA (and…
…order to discuss the value of their idea and obtain important advice and support. Further information is online at http://evs.curemyway.com. Information about MEDICA 2014 exhibitors, product information, company news and…
…order to discuss the value of their idea and obtain important advice and support. Further information is online at http://evs.curemyway.com. Information about MEDICA 2014 exhibitors, product information, company news and…
…21 CFR, Part 820.20(e)” bad news is about to be dropped into the lap of an offending establishment’s chief Jailable officer (CJO), if they have one. Otherwise, the CEO is…
…21 CFR, Part 820.20(e)” bad news is about to be dropped into the lap of an offending establishment’s chief Jailable officer (CJO), if they have one. Otherwise, the CEO is…
…Services Division, including, supervising the research associates and the weekly publication of the “FDA News & Information.” He has a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society….
…Services Division, including, supervising the research associates and the weekly publication of the “FDA News & Information.” He has a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society….
…changes shall be validated before approval and issuance. These validation activities and results shall be documented. Compliance for Dummies The good news is that production and process control is not…
…changes shall be validated before approval and issuance. These validation activities and results shall be documented. Compliance for Dummies The good news is that production and process control is not…
…483 observation. Finally, the good news is that FDA does not retain the authority to review the results of your organization’s supplier audits. However, device establishments must provide objective evidence…
…483 observation. Finally, the good news is that FDA does not retain the authority to review the results of your organization’s supplier audits. However, device establishments must provide objective evidence…
…going well as I was greeted with the news that our television was not working! Now this television was only a month old. We had gone out one beautiful spring…
…going well as I was greeted with the news that our television was not working! Now this television was only a month old. We had gone out one beautiful spring…
…The good news is that FDA does not dictate where and when these reviews are to take place, only that devices establishments hold them and to ensure the design reviews…
…The good news is that FDA does not dictate where and when these reviews are to take place, only that devices establishments hold them and to ensure the design reviews…
…in the medical device karma bank. Otherwise, rest assured your competitors will be knocking on your customer’s door informing them of the great news; “guess who just got a warning…
…in the medical device karma bank. Otherwise, rest assured your competitors will be knocking on your customer’s door informing them of the great news; “guess who just got a warning…
…Group, where he publishes news and analysis regularly on the firm’s QA/RA blog covering medical device industry and regulatory developments in markets worldwide. He has 15 years of experience writing…
…Group, where he publishes news and analysis regularly on the firm’s QA/RA blog covering medical device industry and regulatory developments in markets worldwide. He has 15 years of experience writing…
