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2019 Annual Pharmaceutical Impurities Training Program

4-Part Live Training Program

Instructor: Kim Huynh-Ba Biography>>>
Instructor: Anthony J. DeStefano, Ph.D. Biography>>>

(Former USP Sr. Vice President of General Chapters and Healthcare Quality Standards)


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As an important part of Good Manufacturing Practices (GMPs), monitoring impurities has been placed on the critical path of the development of pharmaceutical products. The objective of this live 4-part series is to thoroughly examine key best practices and regulations in this area. This live training program will address the strategies working with organic, inorganic and solvent impurities in Active Pharmaceutical Ingredients (API) and drug products (DP). A range of regulations from ICH, FDA, EMEA, USP will be discussed.

This 4-part live training program is instructed by Kim Huynh-Ba and Dr. Anthony DeStefano. Kim is the Chair of USP Good Documentation Practices Expert Panel and a member of USP Impurities of Drug Products Expert Panel. Kim co-chaired the organization and the development of the Regulatory Sciences 101 and Stability 101 eLearning courses for AAPS launched in 2014 and 2015. Dr. DeStefano is the former USP Sr. Vice President of General Chapters and Healthcare Quality Standards. While at USP, he lead the effort to replace USP Heavy Metals <231> with the new general chapters <232> and <233>. He is a member of the American Chemical Society (ACS), Chair of the Board of the Product Quality Research Institute (PQRI), and a past president of the American Association of Pharmaceutical Scientists (AAPS).

This intensive 4-part live training program on the topic of pharmaceutical impurities will consist of 4 live training sessions of 2 hours each. It will include over 10 hours of live presentation and live Q&A delivered once a month over the course of 4 months. The method of delivery proves effective in providing trainees with ample time to take in, process, and put to use the information learned then return to the next session with any questions, as opposed to condensing the intensive training program in to a short seminar saturating the audience by an early overload of information. The design and preparation of this live training program’s content is a result of years of practical industry experience, ensuring trainees are provided with the most up to date and practical information on the topic.

Part 1: FDA Guideline on Analytical Procedures and Method Validation with Application to Impurities

Live, Interactive Training Webinar

Date: Wednesday January 30, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Anthony J. DeStefano, Ph.D.

In July, 2015, FDA finalized and issued the February 19, 2014 draft guidance on “Analytical Procedures and Methods Validation for Drugs and Biologics”. This guidance replaces the 2000 draft guidance on “Analytical Procedures and Method Validation” and a similar guidance issued in 1987. Over this span of time FDA has modified its approach to method validation from quite prescriptive to a reliance on risk management and a deep understanding of the purpose, science and statistics of control behind each of the characterization tests.
In this presentation we will review the current guidance in the context of FDA’s current approach to the whole topic of validation and probe how this might impact the thinking behind the selection of methods and acceptance criteria for material characterization and the presentation of this information in regulatory filings. We will also discuss some of the key validation criteria and factors to consider when developing and validating methods that have been deleted from the guidance yet included by reference.

Learning Benefits:
- Review the current FDA guidance on Analytical Procedures and Method Validation
- An in-depth discussion of the guidance in light of FDA’s approach to method development and validation
- A discussion of a science-based approach to the selection of methodology of material characterization and subsequent method validation
- New expectations related to the verification of compendial methodology
- Method development and validation in the context of life-cycle management
- Critical quality attributes and critical process parameters as they relate to method selection, validation and control
- Discussion of key tables referenced but not discussed in the guidance

Webinar outline and time breakdown:

Date: Wednesday January 30, 2019

Time
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM History,
Background – what’s included and what’s not Analytical Methods Development ,
Content of Analytical Procedures,
Reference Standards,
Analytical Method Validation – Non-compendial procedures,
11:30 AM Break
11:40 AM Analytical Method Validation – Compendial Procedures,
Life-cycle Management,
Examples of What to Consider in Method Development and Validation
. Q2 (R1) Table and Factors to Consider
. USP <233> Validation
. USP <467> Residual Solvents Tables and Factors to Consider
. M7 Tables and Factors to Consider,
12:30 PM Live Questions & Discussion

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


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, Interactive Training Webinar

Date: Wednesday February 27, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Kim Huynh-Ba

Monitoring impurity levels in API or drug products is critical to drug development and manufacturing because it can impact the safety and efficacy of the product. ICH has required a control strategy developed and acceptance criteria set for all new products. In January 2018, CDER published the Manual of Policies and Procedures (MAPP) document “Establishing Impurity Acceptance Criteria As Part of Specifications for NDAs, ANDAs, and BLAs Based on Clinical Relevance” to clarify the types of data and information needed when establishing impurity acceptance criteria as part of NDAs, ANDAs, and BLAs. This document focuses on API-related impurities rather than residual solvents and elemental impurities, and importantly, on consideration of the clinical impact of the impurities rather than process capability. CDER's MAPPs are federal directives and documentation of internal policies and procedures. The MAPPs are made available to the public to make CDER a more transparent organization. The principles of this activity are to ensure that the acceptance criteria of impurity are clinically relevant rather than based on manufacturing process capability. A summary of this MAPP will also be discussed to have a better understanding of this policy and review different regulatory requirements from the FDA, ICH, and USP to guide the development of impurity specifications.

Learning Benefits:
- Review FDA guidances, ICH Q3 A/B and USP general chapters impacting impurities
- Understand different thresholds as part of impurity control strategies
- Review warning letters and observations related to impurities
- Introducing the impurity MAPP and its principles
- Responsibilities of the review team
- MAPP recommendations on data, information, and limitations in setting acceptance criteria

Webinar outline and time breakdown:

Date: Wednesday February 27, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Review FDA guidances, ICH Q3 A/B, and USP general chapters impacting the impurities ,
Understand different thresholds as part of impurity control strategies ,
Review warning letters and observations related to impurities,
11:30 AM Break
11:40 AM Introducing the impurity MAPP and its principles,
Responsibilities of the review team,
MAPP recommendations on data, information, and limitations in setting acceptance criteria,
12:30 PM Live Questions & Discussion

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


Part 3: Elemental Impurities Compliance for the Pharmaceutical Industry; Understanding and Implementing USP General Chapters <232> & <233> and A Review of ICH Q3D <1224>

Live, Interactive Training Webinar

Date: Wednesday March 27, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Anthony J. DeStefano, Ph.D.

For over 100 years the United States Pharmacopeia’s (USP) test that provided the specification for heavy metals was general chapter <231> – Heavy Metals. This non-specific test, based on the color intensity of sulfide precipitates, has been replaced by two general chapters. The first, <232> - Elemental Impurities - Limits, is an element-specific, toxicologically-based and risk-based general chapter. It represents a major departure from the previous Heavy Metals test in that a specific list of elements and limits is provided. Each element of concern is associated with a specific permissible daily exposure limit (PDE) for oral, parenteral and inhalational routes of administration. Also, the chapter provides options for assessing the levels of elemental impurities in drug products. The second, <233> - Elemental Impurities – Procedures, discusses two potential procedures for the quantification of the elements of concern (ICP technology with either optical or mass spectrometric detection) as well as validation requirements for this technology and alternative testing. General chapter <232> is globally harmonized via the ICH Q3D document while the testing chapter is under discussion for harmonization by the USP, European and Japanese Pharmacopeias. Both chapters have been effective since January 1, 2018, for both new and existing products.

The subject is of importance to the manufacturers of new drug products as they are required to comply with the new elemental impurities standards either through risk assessments or through testing as new regulatory submissions are made, and to manufacturers of existing products as they make decisions regarding the extent of risk assessment and testing required to demonstrate compliance with the new standards.

The objective of this live training webinar is to provide an understanding of the new USP standards and ICH guideline, what testing, documentation or rationale is required in order to comply with the spirit of the documents, how to perform a proper risk assessment, and how to perform suitable analytical measurements, including the validation of the methodology used to demonstrate compliance.

Learning Benefits:
- A review of the need for new general chapters for elemental impurity evaluation
- An understanding of the logic behind the development and construction of the new standards
- A review of ICH Q3D
- An in-depth discussion of USP <232> and <233>
- Risk assessments
- Compliance strategies
- Updated review of key resources
- Analytical considerations and selecting the best technique
- Analytical method validation

Webinar outline and time breakdown:

Date: Wednesday March 27, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Background – How did we get here?,
USP and the ICH Q3D process,
Elemental Impurities - Limits USP <232> ,
Justification for levels higher than the PDE ,
Risk Assessment Process ,
11:30 AM Break
11:40 AM DRisk Assessment Process Continued,
Sources and control of Elemental Impurities,
What to file considerations,
Analytical Testing – Elemental Impurities – Procedures USP <233>,
12:30 PM Live Questions & Discussion

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


Part 4: Monitoring Organic Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements

Live, Interactive Training Webinar

Date: Wednesday April 24, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Kim Huynh-Ba

Organic impurities are resulted either from the API or Drug product manufacturing process or their degradation products. Monitoring these impurities is considered a critical activity of analytical development to ensure the quality and safety of the pharmaceutical products. Current ICH Guidelines indicate that the measurement of impurities should always be conducted for active pharmaceutical ingredient (API) and its drug products. This live training session will discuss the requirements of ICH Q3A/B on organic impurities and different thresholds to monitor them in the Active Pharmaceutical Ingredients or Drug Products. The concept of Quality by Design (QbD) will also be discussed and applied to the development of analytical procedures including the key factors to be considered through the product lifecycle.

Upon completion of this live training session, attendees will understand regulatory requirements in the monitoring of pharmaceutical impurities. Participants will gain practical knowledge about critical considerations when reporting impurities for regulatory submission. This session will also discuss observations and infractions that were obtained due to recording and reporting impurities in pharmaceutical labs.

Learning Benefits:
- Understanding regulatory expectations for organic impurities
- Understanding ICH regulatory requirement guidelines surrounding impurities in API and Drug Products
- Discussing USP new General Chapters <476> and <1086> impact on the impurity monitoring in drug products including Over-the-counter products
- Distinguishing between process impurities versus degradation products
- Establish specificities for organic impurities and monitoring them through the product lifecycle
- Understanding different thresholds to report for regulatory submission

Webinar outline and time breakdown:

Date: Wednesday April 24, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Understanding regulatory expectations for organic impurities,
Understanding ICH regulatory requirement guidelines surrounding impurities in API and Drug Products ,
Discussing USP new General Chapters <476> and <1086> impact on the impurity monitoring in drug products including Over-the-counter products ,
11:30 AM Break
11:40 AM Distinguishing between process impurities versus degradation products,
Understanding different thresholds to report for regulatory submission. Monitoring impurities through the product lifecycle ,
12:30 PM 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:

  • Analytical Chemists
  • Laboratory Managers
  • Regulatory Compliance Managers
  • Quality Control and Quality Assurance Managers
  • Chemistry, Manufacturing and Control (CMC) Managers
  • Auditors

Click Here to Register for this Live Training Program

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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>>>


Instructor: Anthony J. DeStefano Ph.D. 
Consultant - Former USP Sr. Vice President of General Chapters and Healthcare Quality Standards

Tony DeStefano began his career at Procter & Gamble in mass spectrometry. After P&G acquired Norwich Eaton Pharmaceuticals, he managed Physical Measurement and Method Development Sections for several years, after which he established Norwich’s first Bioanalytical Section. In 2002, he returned to Cincinnati to manage the bioanalysis programs for multiple clinical studies. He has spoken and written extensively in the areas of regulated bioanalysis and analytical and bioanalytical validation and outsourcing. In 2008 he joined the US Pharmacopeia as its Vice President of General Chapters. At USP, he led initiatives to maintain, update and redesign its General Chapters. He was promoted to Senior Vice President and had responsibility for the Health Care Quality Standards, Excipients, Dietary Supplements and Food Ingredients groups. He was a USP representative to the ICH Q3D Expert Working Group on metal impurities and the Pharmacopoeial Discussion Group (PDG). The purpose of the PDG, with representatives from the European Pharmacopoeia, the Japanese Pharmacopoeia, the U.S. Pharmacopeia and the World Health Organization as an observer, is to harmonize pharmacopeial standards (excipient monographs and selected general chapters, including elemental impurities) in three major regions of the world. While at USP, he lead the effort to replace USP Heavy Metals <231> with the new general chapters <232> and <233>. He has spoken extensively regarding these chapters both domestically and internationally. He was a co-developer of the initial USP training course on elemental impurities and served as the trainer for the first session. He is currently a consultant through YourEncore and Nuventra, and personally, consulting on analytical, bioanalytical, compendial and quality-related issues. He is a member of the American Chemical Society (ACS), Chair of the Board of the Product Quality Research Institute (PQRI), and a past president of the American Association of Pharmaceutical Scientists (AAPS)... Full Bio>>>

 
 

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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

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