Robert Packard
30 Followers 2 Followings
Personal Information
Organization / Workplace
Glens Falls, New York Area United States
Occupation
Founder / Instructor
Industry
Medical / Health Care / Pharmaceuticals
Website
http://medicaldeviceacademy.com
About
Robert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE ...
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medical device academy qsit fda 483s fda inspections medical device 21 cfr 820 iso standards medical device inspections fda trends iso auditing tools types of audits medical adjacent link auditing lead auditor regulatory compliance capa complaint handling supplier audits canada usfda usa regulations regulatory europe robert packard free webinar management review template management review
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Personal Information
Organization / Workplace
Glens Falls, New York Area United States
Occupation
Founder / Instructor
Industry
Medical / Health Care / Pharmaceuticals
Website
http://medicaldeviceacademy.com
About
Robert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE ...
Tags
medical device academy qsit fda 483s fda inspections medical device 21 cfr 820 iso standards medical device inspections fda trends iso auditing tools types of audits medical adjacent link auditing lead auditor regulatory compliance capa complaint handling supplier audits canada usfda usa regulations regulatory europe robert packard free webinar management review template management review
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