Upcoming Live Training Programs by Kim Huynh-Ba :

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>>>


2019 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: Thursday October 3, 2019

Part 2: Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports
Live Training Webinar – Date: Thursday October 17, 2019

Part 3 : Change Control for the Stability Program: GMP Requirements & Potential Risks Involved
Live Training Webinar - Date: Thursday October 31, 2019

Part 4 : A Comprehensive Review of Q1D: Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing
Live Training Webinar - Date: Thursday November 14, 2019

Part 5: Developing and Validating Stability Indicating Methods to support Stability Program using Forced Degradation Studies
Live Training Webinar - Date: Tuesday December 3, 2019

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: Thursday December 5, 2019

Detailed 6-Part Live Training Program Agenda>>>


Developing and Validating Stability Indicating Methods to Support Stability Program Using Forced Degradation Studies
Live Training Webinar - Date: Tuesday December 3, 2019 - Time: 10:30 - 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>>>


Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports
Live Training Webinar - Date: Thursday October 17, 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>>>


Change Control for the Stability Program, GMP Requirements & A Review of the Potential Risks Involved
Live Training Webinar - Date: Thursday October 31, 2019 - Time: 10:30 - 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>>>


A Comprehensive Review of Q1D: Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing
Live Training Webinar - Date: Thursday November 14, 2019 - Time: 10:30 - 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>>>


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: Thursday December 5, 2019 - Time: 10:30 - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>


2020 Annual Pharmaceutical Impurities Training Program; A Comprehensive Examination of the Key Best Practices and the Latest Regulatory Expectations from FDA, ICH, EMEA and USP

4-Part Live Training Program - Instructors: Kim Huynh-Ba and Anthony J. DeStefano Ph.D.

Part 1: FDA Guideline on Analytical Procedures and Method Validation with Application to Impurities
Live Training Webinar - Date: Wednesday Feb 5, 2020

Part 2: Understanding the Impact of FDA, ICH, USP and EMEA impurity guidelines, and data needed to establish acceptance criteria according to the FDA Manual of Policy and Procedure (MAPP)
Live Training Webinar - Date: Wednesday Feb 19, 2020

Part 3: 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: Wednesday Mar 4, 2020

Part 4 : Monitoring Organic Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live Training Webinar - Wednesday Mar 18, 2020

Detailed 4-Part Live Training Program Agenda>>>