SEMINARS

Page 1Page 2Page 3Page 4Pre-Recorded

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:    Denver, CO, USA     Dates: September 11 – 14, 2018
Location 2:    Boston, MA, USA     Dates: September 25 – 28, 2018
Location 3:    San Diego, CA, USA     Dates: October 23 – 26, 2018
Location 4:    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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Quality by Design for Medical Devices – Essential Techniques


Location:    Baltimore, MD, USA     Duration: 2 Days
Date: August 2 – 3, 2018 from 9 AM – 5 PM ET
Presenter: Susanne Manz

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ICH Q11 – API Manufacturing Workshop


Location:    Philadelphia, PA, USA     Duration: 2 Days
Date: August 9 – 10, 2018 from 8:30 AM – 4:30 PM ET
Presenter: Peggy J. Berry

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Pharma cGMP Utility Systems Management


Location:    Richmond, VA, USA     Duration: 2 Days
Date: August 16 – 17, 2018 from 9 AM – 5 PM ET
Presenter: Peter T. Vishton

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Auditing IT Systems for Regulatory Compliance


Location:    Tampa, FL, USA     Duration: 2 Days
Date: August 23 – 24, 2018 from 9 AM – 5 PM ET
Presenter: Jon Anderson

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21 CFR Part 11 Compliance for Computer Systems Regulated by FDA


Location:    San Diego, CA, USA     Duration: 2 Days
Date: September 13 – 14, 2018 from 8:30 AM – 4:30 PM PT
Presenter: Carolyn Troiano

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Analytical Method Validation for Pharmaceutical Quality Control


Location:    Zürich, ZH, Switzerland     Duration: 2 Days
Date: September 13 – 14, 2018 from 9 AM – 5 PM CEST
Presenter: Dr. Mark Powell

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


Location:    Houston, TX, USA     Duration: 2 Days
Date: September 19 – 20, 2018 from 9 AM to 6 PM CT
Presenter: John N. Zorich

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Preparation for FDA and EU Regulatory Inspections – 2018 Workshop


Location:    Zürich, ZH, Switzerland     Duration: 2 Days
Date: September 27 – 28, 2018 from 9 AM to 5 PM CEST
Presenter: Robert Haslam

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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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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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GMPs for All Phases – Ensuring GMP Compliance


Location:    Boston, MA, USA     Duration: 2 Days
Date: October 18 – 19, 2018 from 8.30 AM – 4.30 PM ET
Presenter: Peggy J. Berry

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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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Qualification and Validation of Laboratory Equipment and Systems for Regulated Industries


Location:    San Diego, CA, USA     Duration: 2 Days
Date: November 15 – 16, 2018 from 9 AM – 5 PM PT
Presenter: Dr. Shib Mookherjea

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SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations


Location:    Tampa, FL, USA     Duration: 2 Days
Date: December 13 – 14, 2018 from 8.30 AM – 4.30 PM ET
Presenter: Peggy J. Berry

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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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