Statistical Techniques Procedure (SYS-022)

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Statistical Techniques Procedure

This procedure defines requirements for utilizing statistical techniques to establish, control, and verify the acceptability of process capability and product characteristics.

This procedure is the primary document meeting the applicable regulatory requirements for statistical techniques as defined in the Quality System Manual (POL-001).

When is the live webinar scheduled for the Statistical Techniques Procedure?

The live webinar has been rescheduled for Monday, December 9, 2024 @ 10:30 a.m. ET. If you purchased the procedure before December 9th, you will receive login information to participate in the live webinar. The webinar will be hosted on Streamyard.com. If you are unable to participate in the live webinar, please send us your questions in advance so that we can be sure to address your questions in the live webinar. You will be able to download the recording from the Dropbox folder after the live webinar and you can watch it as many times as needed.

Contents Sold with the Statistical Techniques Procedure

Contents of SYS 022 Statistical Techniques Procedure (SYS 022)

If you return the exam to Rob Packard via email in the native Word format, we will grade your exam and provide a corrected version and a certificate for training effectiveness.

Statistical Techniques Procedure Statistical Techniques Procedure (SYS 022)
SYS-022 - Statistical Techniques Procedure
The purpose of this procedure is to define requirements for utilizing statistical techniques for establishing, controlling, and verifying the acceptability of process capability and product characteristics. If you would like to make other payment arrangements, please contact us @ rob@13485cert.com or +1.802.281.4381.
Price: $299.00

Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. To view all available procedures click here.

Rob Packard 300x260 Statistical Techniques Procedure (SYS 022)

Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the 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 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510k submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.258.1881 or by email. You can also follow him on YouTubeLinkedIn, or Instagram.

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