Upcoming Live Training Programs by Peter Calcott Ph.D. :

GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry Including a Review of the New 2018 MHRA Data Integrity Definitions & Guidances and the FDA’s Most Recent Draft Guidance
Live Training Webinar - Date: Thursday November 7, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Supply Chain Security – A Comprehensive Examination of the Latest Technical Challenges from Procurement of Raw Materials to Distribution of Drug Products & Latest FDA, Canada & EU Regulatory Requirements
Live Training Webinar - Date: Wednesday January 22, 2020 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Batch Record Review Process; 2020 FDA, EU and Canada Regulatory Requirements, Key Elements of the Review Process & Emerging Technologies
Live Training Webinar - Date: Wednesday Febraury 12, 2020 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


2020 Annual Pharmaceutical GMP Training Program; Comprehensive Training on the Most Up to Date FDA & Global GMP Requirements and Best Practices

6-Part Live Training Program - Instructors: Peter Calcott Ph.D. & Kim Huynh-Ba

Part 1: Quality Management System (QMS) – The New FDA, EU and Global Regulatory Requirements, Maintaining the Validated State and Driving for Consistency with the ICH Q10 Paradigm
Live Training Webinar - Tuesday March 10, 2020

Part 2: Quality Management System (QMS) – Handling Deviations and Out-of-Spec (OOS) Investigations Based on the Latest FDA, EMA and Global Regulatory Requirements
Live Training Webinar – Date: Thursday March 12, 2020

Part 3 : Facilities, Equipment and Manufacturing – Linking the Latest FDA , EMA and Other Regulatory Bodies' Regulatory Expectations With Respect to Design, Construction, Start Up and Commissioning of Facilities and Utilities and Operations to Best Practices
Live Training Webinar - Date: Tuesday April 7, 2020

Part 4 : Key GMP Requirements of Pharmaceutical Laboratories – Understanding the Latest FDA & Global Regulatory Requirements
Live Training Webinar - Date: Thursday April 9, 2020

Part 5: Raw Materials and Components Management – Latest Regulatory Requirements including a Review of the EMA Falsified Medicines Directive, Food and Drug Administration Safety and Integrity Act (FDAsia), Drug Supply Chain Security Act (DSCSA), & Secure Supply Chain Pilot Program (SSCPP)
Live Training Webinar - Date: Tuesday May 12, 2020

Part 6: GMP Requirements for Records and Reports – Documenting Your GMP Activities; Understanding the Vital GMP Requirements of a Documentation System
Live Training Webinar - Date: Thursday May 14, 2020

Detailed 6-Part Live Training Program Agenda>>>


Human Errors in GMP Manufacturing and Laboratory Processes; Identification, Correction and Prevention, Latest FDA Regulatory Requirements & Most Common GMP Issues Caused by Human Error
Live Training Webinar - Date: Thursday February 20, 2020 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Meeting the Latest Regulatory GMP Requirements During Clinical Manufacturing, Understanding Key Differences in Implementing GMPs in Clinical vs. Commercial Manufacturing
Live Training Webinar - Date: Thursday March 19, 2020 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>