Upcoming Live Training Programs by Kim Huynh-Ba :

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 (Completed)
Live Training Webinar - Date: Wednesday October 2, 2019 (Completed)

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>>>


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>>>


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>>>


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>>>


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 February 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 February 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 March 18, 2020

Part 4 : Monitoring Organic Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live Training Webinar - Wednesday April 1, 2020

Detailed 4-Part Live Training Program Agenda>>>


2020 Annual Pharmaceutical GMP Training Program; Comprehensive Training on the Most Up to Date FDA & Global GMP Requirements and Best Practices

6-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 with the ICH Q10 Paradigm
Live Training Webinar - Tuesday March 10, 2020

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 12, 2020

Part 3 : Facilities, Equipment and Manufacturing – Linking the Latest FDA , EMA and Other Regulatory Bodies' Regulatory Expectations With Respect to Design, Construction, Start Up and Commissioning of Facilities and Utilities and Operations to Best Practices
Live Training Webinar - Date: Tuesday April 7, 2020

Part 4 : Key GMP Requirements of Pharmaceutical Laboratories – Understanding the Latest FDA & Global Regulatory Requirements
Live Training Webinar - Date: Thursday April 9, 2020

Part 5: 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 May 12, 2020

Part 6: GMP Requirements for Records and Reports – Documenting Your GMP Activities; Understanding the Vital GMP Requirements of a Documentation System
Live Training Webinar - Date: Thursday May 14, 2020

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 March 11, 2020 - Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Kim Huynh-Ba
Detailed Information>>>