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

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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 November 29, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


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Industry Including a Review of the New 2018 MHRA Data Integrity Definitions & Guidances and the FDA’s Most Recent Draft Guidance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 December 13, 2018 - Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Cold Chain Management - The Latest Regulatory Requirements for Product Distribution in the USA, Canada, and the EU; Detailed Analysis of the EU GDP Guidance
Live Training Webinar - Date: Wednesday February 20, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


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 21, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


2019 Annual Pharmaceutical GMP Training Program; Comprehensive Training on the Most Up to Date FDA & Global GMP Requirements and Best Practices

8-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
Live Training Webinar - Tuesday March 12, 2019

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 14, 2019

Part 3 : Quality Management System (QMS) – The New QMS Paradigm Explained
Live Training Webinar - Date: Tuesday April 9, 2019

Part 4 : Facilities and Equipment – Linking the Latest FDA , EMA and Other Regulatory Bodies' Regulatory Expectations With Respect to Design, Construction, Start Up and Commissioning of Facilities and Utilities to Best Practices
Live Training Webinar - Date: Thursday April 11, 2019

Part 5: Latest FDA EMA & Other Regulatory Requirements of Pharmaceutical Manufacturing; from Manufacturing of Bulk Drugs to Finished Product Including Packaging and Labeling Activities
Live Training Webinar - Date: Tuesday May 7, 2019

Part 6: Key GMP Requirements of Pharmaceutical Laboratories – Understanding the Latest FDA & Global Regulatory Requirements
Live Training Webinar - Date: Thursday May 9, 2019

Part 7: 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 June 11, 2019

Part 8: GMP Requirements for Records and Reports – Documenting Your GMP Activities; Understanding the Vital GMP Requirements of a Documentation System
Live Training Webinar - Date: Thursday June 13, 2019

Detailed 8-Part Live Training Program Agenda>>>


Quality Management System (QMS) – The New FDA, EU and Global Regulatory Requirements, Maintaining the Validated State and Driving for Consistency
Live Training Webinar - Date: Tuesday March 12, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Quality Management System (QMS) – The New QMS Paradigm Explained - Comparing Commonalities Between FDA, EMA and Other International Regulatory Requirements
Live Training Webinar - Date: Tuesday April 9, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Facilities and Equipment – Linking the Latest FDA , EMA and Other Regulatory Bodies' Regulatory Expectations With Respect to Design, Construction, Start Up and Commissioning of Facilities and Utilities to Best Practices
Live Training Webinar - Date: Thursday April 11, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Latest FDA EMA & Other Regulatory Requirements of Pharmaceutical Manufacturing; from Manufacturing of Bulk Drugs to Finished Product Including Packaging and Labeling Activities
Live Training Webinar - Date: Tuesday May 7, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Lot Disposition; A Thorough Review and Comparison of the Latest Regulatory Expectations Governing and Controlling Lot Disposition in US, Canada and the EU
Live Training Webinar - Date: Thursday May 16, 2019 - Time: 10:30 AM - 12:30 PM ET(New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Supply Chain Security – An Inclusive Examination of the Latest Challenges in Technical and Cold Chain Areas from Procurement of Raw Materials to Distribution of Drug Products & Latest FDA, Canada & EU Regulatory Requirements
2-Part Live Training Program - Instructor: Peter Calcott Ph.D.

Part 1: Part 1 - Supply Chain Security – Understanding the Latest FDA, Canada and EU Regulatory Requirements
Live Training Webinar - Date: Wednesday May 29, 2019

Part 2: Supply Chain Security – How the EU, Canada and USA Approach the Requirements to Protect Our Products and the Direction it is Heading
Live Training Webinar - Date: Wednesday June 5 2019

2-Part Live Training Program Time: 10:30 - 12:30 PM ET (New York Time)

Detailed 2-Part Live Training Program Agenda>>>


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 June 11, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>


Batch Record Review Process; 2018 FDA, EU and Canada Regulatory Requirements, Key Elements of the Review Process & Emerging Technologies
Live Training Webinar - Date: Thursday July 18, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Detailed Information>>>