SEMINARS

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TMF Plus and eCTD Plus (Companion Workshops)


Workshop 1: TMF Plus – Requirements, Best Practices and Tools to Manage Regulated Documents, Files, Submissions, and Dossiers
Workshop 2: eCTD Plus – Concepts, Processes, and Tools for eCTD Publishing

Location 1:    San Diego, CA, USA     Dates: October 23 – 26, 2018
Location 2:    Miami, FL, USA     Dates: December 4 – 7, 2018

Timing: 8.30 AM – 4.30 PM     Duration: 4 Days (2 days each)
Presenters: Daniel F. Orfe & Betsy A. Fallen

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Technical Training for Life Sciences Industry


Location:    Raleigh, NC, USA     Duration: 2 Days
Date: September 27 – 28, 2018 from 9 AM to 4.30 PM ET
Presenter: Charles H. Paul

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Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)


Location:    Raleigh, NC, USA     Duration: 2 Days
Date: October 4 – 5, 2018 from 9 AM to 4.30 PM ET
Presenter: Joy McElroy

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Demystifying the Quality Management System and Controlled Documents


Location:    Newark, NJ, USA     Duration: 2 Days
Date: October 11 – 12, 2018 from 8.30 AM – 4.30 PM ET
Presenter: José Mora

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Developing Effective Compliant Documentation and Training System


Location:    Houston, TX, USA     Duration: 2 Days
Date: October 11 – 12, 2018 from 9 AM – 4.30 PM CT
Presenter: Charles H. Paul

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Advanced Quality Auditing – 2018 Workshop


Location:    Seattle, WA, USA     Duration: 2 Days
Date: October 17 – 18, 2018 from 8 AM – 5 PM PT
Presenter: Lance B. Coleman Sr.

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21 CFR Part 11 Compliance for Computer Systems Regulated by FDA


Location:    Richmond, VA, USA     Duration: 2 Days
Date: October 18 – 19, 2018 from 8:30 AM – 4:30 PM ET
Presenter: Carolyn Troiano

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FDA’s New Import Program for 2018 – Strict Precision


Location:    Fort Wayne, IN, USA     Duration: 2 Days
Date: October 18 – 19, 2018 from 8.30 AM – 4.30 PM ET
Presenter: Casper E. Uldriks

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Audit Like the FDA – Effective Internal Audit Program


Location:    St. Paul, MN, USA     Duration: 2 Days
Date: November 5 – 6, 2018 from 9 AM – 5 PM CT
Presenter: Susanne Manz

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Technical Report Writing and Statistical Analysis for the Pharmaceutical Industry


Location:    Zürich, ZH, Switzerland     Duration: 2 Days
Date: November 8 – 9, 2018 from 9 AM – 5 PM CEST
Presenter: Dr. Mark Powell

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Governance and Change Control according to GxP and GMP Requirements


Location:    Raleigh, NC, USA     Duration: 2 Days
Date: November 15 – 16, 2018 from 9 AM – 4 PM ET
Presenter: Kelly Thomas

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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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Equipment Qualification and Validation of Processes in The Manufacturing Environment


Location: PRE-RECORDED COURSE     Duration: 3 Hours
Presenter: Jeff Kasoff

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Quality Control Laboratory Compliance – cGMPs and GLPs


Location: PRE-RECORDED COURSE     Duration: 6 Hours
Presenter: Joy McElroy

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