Upcoming Live Training Programs by Kim Huynh-Ba :

2019 Annual Pharmaceutical Stability Training Program

5-Part Live Training Program - Instructor: Kim Huynh-Ba

Part 1: Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports
Live Training Webinar – Date: Wednesday April 10, 2019

Part 2: Change Control for the Stability Program: GMP Requirements & Potential Risks Involved
Live Training Webinar - Date: Wednesday May 8, 2019

Part 3: A Comprehensive Review of Q1D: Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing
Live Training Webinar - Date: Wednesday June 12, 2019

Part 4: Developing and Validating Stability Indicating Methods to support Stability Program using Forced Degradation Studies
Live Training Webinar - Date: Wednesday July 10, 2019

Part 5: Monitoring Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live Training Webinar - Date: Wednesday August 14, 2019

Detailed 5-Part Live Training Program Agenda>>>


Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports
Live Training Webinar - Date: Wednesday April 10, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Monitoring Organic Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live Training Webinar - Date: Wednesday April 24, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Change Control for the Stability Program, GMP Requirements & A Review of the Potential Risks Involved
Live Training Webinar - Date: Wednesday May 8, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Key GMP Requirements of Pharmaceutical Laboratories – Understanding the Latest FDA & Global Regulatory Requirements
Live Training Webinar - Date: Thursday May 9, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


A Comprehensive Review of Q1D: Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing
Live Training Webinar - Date: Wednesday June 12, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


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 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Developing and Validating Stability Indicating Methods to Support Stability Program Using Forced Degradation Studies
Live Training Webinar - Date: Wednesday July 10, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Monitoring Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live Training Webinar - Date: Wednesday August 14, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


2019 Annual Method Validation Training Program; Latest Regulatory Expectations and Guidance from FDA, ICH, USP & Best Practices for GMP Pharmaceutical Laboratories

4-Part Live Training Program - Instructor: Kim Huynh-Ba

Part 1: Validation Life-Cycle Management (LCM) of Analytical Procedures According to FDA, ICH and USP Requirements
Live Training Webinar - Date: Tuesday September 10, 2019

Part 2: Developing an Effective Method Validation Protocol
Live Training Webinar - Date: Tuesday October 1, 2019

Part 3: Fundamental Principles of Method Transfer, A Comprehensive Review of USP <1224> and Key Factors that Influence the Transfer of Analytical Methods
Live Training Webinar - Date: Tuesday October 29, 2019

Part 4: Analytical Method Modification and Change Control Process
Live Training Webinar - Date: Tuesday November 12, 2019

Detailed 4-Part Live Training Program Agenda>>>


Validation Life-Cycle Management (LCM) of Analytical Procedures According to FDA, ICH and USP Requirements
Live Training Webinar - Date: Tuesday September 10, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Developing an Effective Method Validation Protocol
Live Training Webinar - Date: Tuesday October 1, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Best Practices, Key Components and a Comprehensive Review of the FDA Requirements - Avoiding Deficiencies and Ensuring Continuous Improvement through a Complete Investigation Process

Annual 4-Part Live Training Program - Instructor: Kim Huynh-Ba

Part 1: Identification of Out-of-Specification (OOS) and the Investigation Process - A Comprehensive Review of the FDA Guidance and Requirements
Live Training Webinar - Date: Wednesday October 2, 2019

Part 2: Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
Live Training Webinar - Date: Wednesday October 30, 2019

Part 3: Developing Investigation Plans and Writing Investigation Reports
Live Training Webinar - Date: Wednesday November 13, 2019

Part 4 : Laboratory Deficiencies and How to Minimize OOS/OOT
Live Training Webinar - Wednesday December 4, 2019

Detailed 4-Part Live Training Program Agenda>>>


Identification of Out-of-Specification (OOS) and the Investigation Process - A Comprehensive Review of the FDA Guidance and Requirements
Live Training Webinar - Date: Wednesday October 2, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


FDA & International Stability Requirements in the Drug Development Process including WHO, ASEAN and ICH Q1AR2
Live Training Webinar - Date: Thursday October 3, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Fundamental Principles of Method Transfer, A Comprehensive Review of USP <1224> and Key Factors that Influence the Transfer of Analytical Methods
Live Training Webinar - Date: Tuesday October 29, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
Live Training Webinar - Date: Wednesday October 30, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


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 November 12, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Developing Investigation Plans and Writing Investigation Reports
Live Training Webinar - Date: Wednesday November 13, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Laboratory Deficiencies and How to Minimize OOS/OOT
Live Training Webinar - Date: Wednesday December 4, 2019 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>