Upcoming Live Training Programs:
Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production– FDA & ICH Expectations and Guidance
Live Training Webinar
Date: Tuesday October 3, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry - A Comprehensive Review of the Latest MHRA Data Integrity Definitions and Guidances Including the FDA’s Most Recent Guidance
Live Training Webinar
Date: Wednesday October 4, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Control of Nitrosamine Impurities in Human Drugs - Understanding FDA's Final Guidance for Industry, USP Chapter <1469> and an In-depth Discussion of Sample Preparation Issues, Methodology and Acceptance Criteria
Live Training Webinar
Date: Thursday October 5, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Anthony J. DeStefano Ph.D.
Developing an Effective Method Validation Protocol; Systems for Protocol Amendment, Deviations & How to Handle Protocol Failures and Investigations
Live Training Webinar
Date: Tuesday October 10, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Developing Investigation Plans and Writing Investigation Reports
Live Training Webinar
Date: Wednesday October 11, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
FDA's Endotoxins/Pyrogens Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices. A Comprehensive Review of the Current Testing Requirements & The USP Microbiology Expert Committee’s Opinion on Low Endotoxin Recovery (LER)
Live Training Webinar
Date: Monday October 16, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Barry Friedman Ph.D.
Fundamental Principles of Method Transfer: A Systematic Way to Qualify a New Lab to Perform Analytical Testing & A Review of USP <1224>
Live Training Webinar
Date: Tuesday October 17, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Laboratory Deficiencies and How to Minimize OOS/OOT
Live Training Webinar
Date: Wednesday October 18, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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: Wednesday October 25, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements and the Impact of the New FDA Quality Metrics Guidance on Annual Product Reviews
Live Training Webinar
Date: Thursday October 20, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Jerry Lanese Ph.D.
Analytical Method Modification and Change Control Process; Documentation System, cGMP Requirements and a Review of Q2 A & B for Method Validation Activities
Live Training Webinar
Date: Tuesday October 31, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
2023 Annual Pharmaceutical Stability Training Program
6-Part Live Training Program - Instructor: Kim Huynh-Ba
Part 1: Understanding FDA & International Stability Requirements in the Drug Development Process including WHO, ASEAN and ICH Q1AR2
Live Training Webinar - Date: Wednesday November 1, 2023
Part 2: Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports
Live Training Webinar - Date: Wednesday November 8, 2023
Part 3: Change Control for the Stability Program: GMP Requirements & Potential Risks Involved
Live Training Webinar - Date: Wednesday November 15, 2023
Part 4: A Comprehensive Review of Q1D: Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing
Live Training Webinar - Date: Wednesday November 29, 2023
Part 5: Developing and Validating Stability Indicating Methods to support Stability Program using Forced Degradation Studies
Live Training Webinar - Date: Wednesday December 6, 2023
Part 6: Design and Implement an Effective Stability Program to Support Marketed Products and Maintain Compliance to the Latest FDA, ICH and WHO Regulatory Requirements.
Live Training Webinar - Date: Wednesday December 13, 2023
FDA & International Stability Requirements in the Drug Development Process including WHO, ASEAN and ICH Q1AR2
Live Training Webinar
Date: Wednesday November 1, 2023 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Batch Record Review Process; 2023 FDA, EU and Canada Regulatory Requirements, Key Elements of the Review Process & Emerging Technologies
Live Training Webinar
Date: Thursday November 2, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Peter Calcott Ph.D.
Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports
Live Training Webinar
Date: Wednesday November 8, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations
Live Training Webinar
Date: Thursday November 9, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Jerry Lanese
Change Control for the Stability Program, GMP Requirements & A Review of the Potential Risks Involved
Live Training Webinar
Date: Wednesday November 15, 2023 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
A Comprehensive Review of Q1D: Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing
Live Training Webinar
Date: Wednesday November 29, 2023 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Developing and Validating Stability Indicating Methods to Support Stability Program Using Forced Degradation Studies
Live Training Webinar
Date: Wednesday December 6, 2023 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Elemental Impurities Compliance for the Pharmaceutical Industry Understanding and Implementing USP General Chapters <232> & <233> and A Review of ICH Q3D
Live Training Webinar
Date: Thursday December 7, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Anthony J. DeStefano Ph.D.
Design and Implement an Effective Stability Program to Support Marketed Products and Maintain Compliance to the Latest FDA, ICH and WHO Regulatory Requirements
Live Training Webinar
Date: Wednesday December 13, 2023 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba