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Hack Night
12/2/2014 5:00 PM - 9:00 PM
Assembly Coworking Space Calgary Canada
Event Listing
Summary:

Every Tuesday night from 6pm to 10pm, “Hack Nights” come alive with hustlers, hackers and hipsters coming together to work on their start-up ideas. If you are working on something tech related, and are in the pre-investment stage, this event is for you!

Hack Night
12/9/2014 5:00 PM - 9:00 PM
Assembly Coworking Space Calgary Canada
Event Listing
Summary:

Every Tuesday night from 6pm to 10pm, “Hack Nights” come alive with hustlers, hackers and hipsters coming together to work on their start-up ideas. If you are working on something tech related, and are in the pre-investment stage, this event is for you!

Webinar On 21 CFR 11 Compliance for Excel Spreadsheets
11/18/2014 1:00 PM - 2:30 PM
Online Mississauga, Ohio Canada
Event Listing
Summary:

In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings.

Webinar On Annual Reports for Approved PMAs
11/7/2014 1:00 PM - 3:00 PM
Online Mississauga, Ohio Canada
Event Listing
Summary:

A must attend webinar for those personnel that require an understanding of the FDA’s requirements for PMA annual reports.

Webinar On Best Practices for 510k Drafting and Submission Dos and Donts
11/18/2014 1:00 PM - 2:30 PM
Online Mississauga, Ohio Canada
Event Listing
Summary:

From this webinar you will learn best practices for adequately putting your 510(k) together for your successful submission to the FDA, compliant with the FDA’s eCopy and RTA policy.

Webinar on Best Practices for Medical Device Recalls
11/6/2014 1:00 PM - 3:00 PM
Online Mississauga, Ohio Canada
Event Listing
Summary:

This webinar will provide a great opportunity to adequately plan, develop and execute the relevant procedures in an effective, sustainable manner compliant with the recall requirements enforced by US FDA.

Webinar On Confidence Reliability Calculations and Statistically Valid Sample Sizes
11/13/2014 1:00 PM - 2:30 PM
Online Mississauga, Ohio Canada
Event Listing
Summary:

The seminar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.

Webinar On Corrective and Preventative Action CAPA Throughout the Product Lifecycle
11/14/2014 1:00 PM - 11/18/2014 2:30 PM
Online Mississauga, Ohio Canada
Event Listing
Summary:

This webinar will discuss how the CAPA system and associated processes such as design control, risk management, process control, and investigations can be utilized throughout the product lifecycle to address defect prevention. Both medical devices and pharmaceuticals will be included.

Webinar On DeNovo Classification Process
11/24/2014 1:00 PM - 3:00 PM
Online Mississauga, Ohio Canada
Event Listing
Summary:

This is a must attend session for those personnel that require an understanding of the FDA’s DeNovo Classification process.

Webinar On Establishing a Robust Complaint Management System
11/20/2014 1:00 PM - 2:00 PM
Online Mississauga, Ohio Canada
Event Listing
Summary:

This Webinar will breakdown the complaint management process so attendees will be exposed to a clear, concise and compliant approach to complaint management in accordance with 21 CFR, Part 820.198 requirements.

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