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

3-Part Live Training Program
Instructor: Kim Huynh-Ba Biography>>>

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In the pharmaceutical industry, analytical procedures are used to control and monitor the quality of drug substance and drug products to assure their identity, potency, purity and quality. Therefore, validation of analytical procedures is a critical activity to guarantee that the methods perform as their intended purpose. Therefore, analytical procedures require the Pharmaceutical QC laboratories to understand the latest regulatory requirements. It is a critical component of a quality management system in GMP and ISO regulations. In February 2014, CDER and CBER have collaborated to issue a new Guidance for Industry “Analytical Procedures and Method Validation for Drug and Biologics” introduce many changes to the analytical practices from principles to implementation. This training series is designed as a comprehensive program to discuss the latest regulatory requirements, compliance practices, method transfer and change control program surrounding analytical procedures used in GMP pharmaceutical laboratories.

This 3-part live training program on the topic of Method Validation will consist of 3 live training sessions of 2 hours each. It will include over 8 hours of live presentation, discussion and live Q&A. This live training series is designed as a comprehensive program to discuss latest regulatory requirements, compliance practices, method transfer and change control program surrounding analytical procedures used in GMP pharmaceutical laboratories.

Part 1: Developing an Effective Method Validation Protocol; Systems for Protocol Amendment, Deviations & How to Handle Protocol Failures and Investigations

Live, Interactive Training Webinar

Date: Tuesday September 25, 2018
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba

Analytical procedures are used to monitor and control drug products. Therefore, these procedures must show accuracy, precision as well as reliability for drug analysis. Preparation of these validations must be done carefully via validation protocols to meet compliance and regulatory requirements. Companies should have a consistent approach to develop validation protocol focus on product and process understanding. This session will discuss procedure to establish validation protocol, design training activity and define validation objectives. In addition, we’ll also discuss systems for protocol amendment and deviations as well as how to handle protocol failures and investigation. This series will focus on analytical methods for small molecule drug products.

Learning Benefits:
-Identify validation parameters.
-Establish validation goal and purpose of method.
-Establish acceptance criteria.
-Establish training activity.
-Execute the validation protocol.
-Evaluate results.
-Protocol amendment and deviation.
-Handling investigation of failures

Webinar outline and time breakdown:

Date: Tuesday September 25, 2018

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Structure of a validation protocol,
Identify validation parameters,
Establish validation goal and purpose of method,
Establish acceptance criteria,
10:30 AM Break
10:40 AM Establish training activity,
Execute the validation protocol,
Evaluate results and validation report,
Protocol amendment and deviation,
Handling investigation of failures,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 2: Fundamental Principles of Method Transfer: A Systematic Way to Qualify a New Lab to Perform Analytical Testing & A Review of USP <1224>

Live, Interactive Training Webinar

Date: Tuesday October 30, 2018
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba

Analytical methods are a major tool in the pharmaceutical development to control the quality and integrity of the active drug substance or drug product. Methods are normally developed at one site and then transferred to one or more sites during the drug development process or as a post-approval activity. Qualifying analysts to perform these methods is a critical activity that would significantly impact the launch of a product. Activities of a method transfer process must be managed effectively to deliver an analytical method from one site to another or one department to another.

This session will present fundamental principles of a method transfer and discuss options to conduct method transfer. A review of USP General Chapter <1224> will also be included and key factors that would influence the transfer of analytical methods from one site to another will also be discussed.

Learning Benefits:
-Understand key factors of method transfer.
-Define roles and responsibilities of transfer team.
-Discuss requirements to qualify a laboratory.
-Develop appropriate transfer strategy to streamline processes.
-Understand transfer options listed in USP <1224>.
-Discuss different phases of method transfer.

Webinar outline and time breakdown:

Date: Tuesday October 30, 2018

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Understand key factors of method transfer,
Define roles and responsibilities of transfer team,
Discuss requirements to qualify a laboratory,
10:30 AM Break
10:40 AM Develop appropriate transfer strategy to streamline processes,
Understand transfer options listed in USP<1224>,
Discuss different phases of method transfer,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 3: Analytical Method Modification, Validation and Change Control Process; Documentation System, cGMP Requirements and a Review of Q2 A & B for Method Validation Activities

Live, Interactive Training Webinar

Date: Tuesday November 27, 2018
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba

Safety and efficacy of a drug product are established with clinical studies throughout drug development. Therefore, analytical procedures are required to be fully validated for their intended use of the approved conditions. When changes are made to an approval process, there are concerns of maintaining product quality as well as cost of process improvement. Pharmaceutical companies are required to establish a change control process to evaluate potential changes and minimize the impact of registration. Establishment of new specifications as a result of method changes will also be discussed.

This live and interactive session will focus on potential changes of analytical procedures, and how to develop a change control system that minimize impact of registration. Characterize these changes will also be discussed to ensure the analytical procedures continue to perform within validated state. Documentation system will also be discussed to complete the record of these changes and able to monitor the product as long as it is available on the market.

Learning Benefits:
-Understanding cGMP requirements of method validation.
-Review Q2 A&B for method validation activities.
-Discuss changes that may be necessary for analytical procedures.
-Discuss the key elements of change control system.
-Establish a change control so that these method changes can be verified.
-Documentation system necessary to verify that procedure continues to be valid within its intended use.
-Establish new specifications resulted from method changes.

Webinar outline and time breakdown:

Date: Tuesday November 27, 2018

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Understanding cGMP requirements of method validation,
Change control: key element of the quality system,
Discuss the key elements of change control system,
Review Q2 A&B for method validation activities,
10:30 AM Break
10:40 AM Establish a change control so that these method changes can be verified,
Documentation system necessary to verify that procedure continues to be valid within its intended use,
Establish new specifications resulted from method changes,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


This comprehensive 4-Part live training program includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Auditors

Register for this Live Training Program >>>

Instructor: Kim Huynh-Ba

Kim has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she held technical positions in drug development at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Her experiences range from analytical development to supporting CMC activities of multiple regulatory submissions, addressing regulatory responses to observations or investigations, or developing stability submission strategies.

She is an Adjunct Professor at Temple University-School of Pharmacy, Illinois Institute of Technology and Widener University. Kim currently is a member of United States Pharmacopeia (USP) General Chapter Expert Committee (2010-2015) and USP’s Reference Standard Project Team (2009-2010). She is also a member of the CHPA’s Impurities Breakout Group. She is chair of AAPS APQ Distance Learning and organized several APQ Open Forums. She serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS). She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” published in 11/2008, and also “Pharmaceutical Stability Testing to Support Global Markets” published in 01/2010… Full Bio>>>


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2018 Annual Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations Best Practices and FDA Latest Regulatory Requirements

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 17, 2018

Part 2: Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management
Live Training Webinar - Date: Wednesday October 31, 2018

Part 3: Developing Investigation Plans and Writing Investigation Reports
Live Training Webinar - Date: Wednesday November 28, 2018

Part 4 : Laboratory Deficiencies and How to Minimize OOS/OOT
Live Training Webinar - Wednesday December 5, 2018

Detailed 4-Part Live Training Program Agenda>>>


 

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland

Clients: