SEMINARS

Page 1Page 2Page 3Pre-Recorded

Equipment Qualification and Validation of Processes in The Manufacturing Environment


Location: ONLINE     Duration: 3 Hours
Date: February 21, 2018 from 1 PM – 4 PM ET
Presenter: Jeff Kasoff

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FDA Audit, Quality Assurance Practices, Responsibilities and Expectations


Location:   Toronto, ON, Canada     Duration: 2 Days
Date: February 22 – 23, 2018 from 9 AM – 5 PM ET
Presenter: Kenneth Christie

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Quality Control Laboratory Compliance – cGMPs and GLPs


Location: ONLINE     Duration: 1 Day
Date: February 27, 2018 from 12 PM – 6 PM ET
Presenter: Joy McElroy

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21 CFR Part 11 Compliance for Computer Systems Regulated by FDA


Location:   Los Angeles, CA, USA     Duration: 2 Days
Date: March 1 – 2, 2018 from 9 AM – 5 PM PT
Presenter: Carolyn Troiano

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Process Validation for Drugs and Biologics


Location: ONLINE     Duration: 3 hours
Date: March 6, 2018 from 1 PM – 4 PM ET
Presenter: Joy McElroy

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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada


Location:    Philadelphia, PA, USA     Duration: 2 Days
Date: March 8 – 9, 2017 from 8.30 AM – 4.30 PM ET
Presenter: Peggy J Berry

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Root Cause Analysis and Corrective Action – 2-Part Web Series


Location: ONLINE     Duration: 4 Hours
Dates: March 9 & 16, 2018 from 1 PM – 3 PM ET
Presenter: Lance B. Coleman

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GMP for Quality Control Laboratories and FDA Audit Preparation


Location:   Hyderabad, TS, India     Duration: 2 Days
Date: February 22 – 23, 2018 from 9 AM – 5 PM IST

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Medical Devices Virtual Seminar


Location: ONLINE     Duration: 4 Hours
Date: March 14, 2018 from 12 PM – 4 PM ET
Presenter: Robert Braido

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Medical Device Single Audit Program (MDSAP) – Implementation


Location:    Toronto, ON, Canada     Duration: 2 Days
Date: March 12 – 13, 2018 from 8 AM – 5.30 PM ET
Presenter: Rai Chowdhary

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Project Management for Non-Project Managers


Location:    Philadelphia, PA, USA     Duration: 2 Days
Date: March 15 – 16, 2017 from 9 AM – 5 PM ET
Presenter: Charles H Paul

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FDA Audit, Quality Assurance Practices, Responsibilities and Expectations


Location:    Philadelphia, PA, USA     Duration: 2 Days
Date: March 22 – 23, 2018 from 9 AM – 5 PM ET
Presenter: Kenneth Christie

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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada


Location:    Philadelphia, PA, USA     Duration: 2 Days
Date: April 12 – 13, 2017 from 8.30 AM – 4.30 PM ET
Presenter: Peggy J Berry

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Statistical Methods for Design Verification, Process Validation, and Process Control


Location:    Houston, TX, USA     Duration: 2 Days
Date: April 19 – 20, 2018 from 9 AM – 5 PM CT
Presenter: John N Zorich Jr

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Analytical Instrument Qualification and Validation – Understanding Use of Excel and FDA Audit Preparation


Location:    Raleigh, NC, USA     Duration: 2 Days
Date: April 19 – 20, 2018 from 9 AM – 6 PM ET
Presenter: Joy McElroy

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Medical Device Single Audit Program (MDSAP) – Implementation


Location:    Philadelphia, PA, USA     Duration: 2 Days
Date: April 19 – 20, 2018 from 8 AM – 4.30 PM ET
Presenter: Rai Chowdhary

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21 CFR Part 11 Compliance for Computer Systems Regulated by FDA


Location:    Richmond, VA, USA     Duration: 2 Days
Date: April 26 – 27, 2018 from 9 AM – 5 PM ET
Presenter: Carolyn Troiano

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Supplier Management in FDA and ISO-Regulated Industry


Location:    Houston, TX, USA     Duration: 2 Days
Date: April 26 – 27, 2018 from 9 AM – 4 PM CT
Presenter: Jeff Kasoff

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Building a Compliant Documentation and Training System


Location: PRE-RECORDED COURSE     Duration: 3 Hours
Presenter: Charles H. Paul

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510(k) Update – How to Format Succinct and Comprehensive 510(k)s


Location: PRE-RECORDED COURSE     Duration: 3 Hours
Presenter: Dr. David Lim

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