Upcoming Live Training Programs by Kim Huynh-Ba :
Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
Live Training Webinar
Date: Wednesday September 27, 2023 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
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
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
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
Detailed 6-Part Live Training Program Agenda>>>
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
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
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