ComplianceOnline

In this two day workshop conference you will learn the different global agencies’ expectations of meeting the new guidelines. Different strategies for compliance will be presented with numerous illustrative examples. To place Q3D in context of other regulatory guidelines, a key segment on QbD principles, particularly risk assessment, will also be presented.

Learning Objectives:

Upon completing this course participants should:

  • Understand the regulatory agencies’ expectations for compliance of pharmaceuticals with ICH Q3D
  • Understand the timelines and schedules for compliance
  • Understand how to utilize a risk-based approach to address implementation of elemental impurities requirements
  • Understand the general strategies for compliance, with pros and cons
  • Develop an integrated, implementable plan for Regulatory, Manufacturing, and Quality to comply with ICH Q3D
  • Understand the requirements for analytical instrumental methods to comply with ICH Q3D
  • Understand the deliverables required of Regulatory affairs to comply
  • Understand the depth and design of studies required of Manufacturing to comply
  • Understand the documents required of Quality to comply
  • Understand what is meant by Quality by Design
  • Understand the benefits from applying a QbD approach
  • Provide key steps to implement a QbD program
  • Understand the important tools used to implement a QbD approach
If you are looking for answer of these questions, you would certainly benefit by attending this seminar:
  • What are the requirements for analytical instrumental methods to comply with ICH Q3D?
  • What are all the deliverables required of Regulatory affairs to be in compliance?
  • What is the depth and design of studies required of Manufacturing to be in compliance?
  • What are all the documents required of Quality to be in compliance?

Who will Benefit:

Implementation of Elemental Impurities testing is a shared responsibility between multiple functions in an organization.. Quality Managers will benefit greatly from this course due to their role in defining and defending the compliance aspects of these activities. R&D and Engineering will benefit due to their responsibility as Product Stewards. Regulatory has a significant role in providing updated product files to the authorities. These functions must understand the implications of their actions with respect to overall compliance. Other functions include:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production managers
  • Manufacturing engineers
  • Production engineers
  • Design engineers and managers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Topic Background:

Mandatory ICH Q3D/USP testing for elemental impurities (EI) in current, finished drug products becomes law on January 1, 2018. In both Europe and the US, the EQDM/EMA and FDA deadlines for compliance of new marketing authorization and new drug applications, respectively, with ICH Q3D became effective June 2016. Implementation requires extensive prior work. The new EI limits require more sophisticated analytical technology, such as ICP-MS, not routinely used in QC labs. The ultra-sensitive analytical method must be validated specifically for all of your different dosage forms. Additionally, a risk managed approach is required to understand the contributions from your entire manufacturing process to 27 different designated trace elements of concern. Each EI has different limits, which vary depending upon the dosing volume of each different dosage form. Implementation requires considerable additional resources including capital expenditure for instrumentation in each plant and back-up with highly trained analysts (and back-up).

Practical implementation of ICH Q3D establishes a risk based approach. The fundamental challenge, however, is to find a means to categorize risk. This means an exhaustive assessment of all the components of manufacturing including API, excipients, water, manufacturing equipment, processing aids, and container closure system to determine their contributions to all 27 EI. Alternatively, it is possible to simply do final product testing on finished dosage forms. This carries the risk, however, that failure here involves discarding the batch.

Regulatory dossiers for all products must be updated to include: an updated drug product specification table (test, method(s), limits); non-compendial test method(s), relevant reference standards used, and validation package; summary of identified EI and observed or projected levels; data from representative commercial batches (component or drug product dependent upon the approach taken); summary of product risk assessment (discussing risks and controls); conclusion of the product assessment, demonstrating compliance with established Permissible Daily Exposures (PDE) of identified EI; post-approval stability protocols if updated for EI testing.

Implementation imposes considerable new requirements upon the company pharmaceutical quality system. These include: drug product specification table (test, method(s), limits); non-compendial test method(s), relevant reference standards used, and validation package; GMP related processes to limit the inclusion of EI, change management processes (triggers for updates); periodic review; original data used in the product assessments, quality agreements, supplier qualification, etc.

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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction, Background, and Rationale
  • EI limits and comparative requirements between ICH vs FDA
    • Calculations of Dosage Form Limits
    • EI Prioritization by toxicity
  • Timelines for implementation
    • ICH
    • USP/FDA
    • EU
  • Various strategies for Implementation
    • Test every finished batch for all EI
    • Risk Based Assessment
      • Common document approach
      • Where to focus attention
    • Component approach vs final product testing
    • FDA guidance
    • Decision-making based on safety, economics, product risk
  • Benchmarking- what are other companies doing?
  • Required documentation, submissions
    • Regulatory
      • Product Risk Assessment
      • Results of testing conducted
      • Regulatory submissions-new specs, methods, validations
    • Quality
      • New GMP procedures to demonstrate compliance
      • Change management controls
  • Manufacturing Process Analysis
    • Water
    • API
    • Excipients
    • Stainless transfer tanks and lines
    • Container Closure System
  • Analytical Testing, Validation, Transfer
    • Placing an R&D method in a plant environment
    • Instrument selection criteria
    • Training and maintenance
    • Reference Standards
    • Costs
    • CRO Evaluations
  • Application to Other dosage forms
  • Literature survey of elemental impurities
    • Materials of container/closure systems
    • Excipients
Day 02(8:30 AM - 4:30 PM)
  • Introductions and QbD Overview
    • QbD Overview
    • What is QbD
    • What does a QbD program look like
  • Quality Target Profile Introduction (QTPP)
    • QTPP ICH background
    • Factors to consider
    • Implementation
  • Introduction to Risk Evaluations and Early Risk Assessments
    • Description
    • Information flow
    • Tool Use example
    • Benefits
  • Integrating the QTPP and risk assessments into your development program
    • Mapping QTPP and Risk Assessments into the scientific investigations
    • Prioritizing efforts
    • Identifying Critical Quality Attributes
  • Design Space Development
    • Definition
    • Concepts to develop a design space
    • Graphical representation
  • Later Stage Risk Evaluations. (FMEA)
    • Purpose of an FMEA
    • Design and application
  • Designing the Control Strategy
    • Definition
    • Approach for developing
  • Technology Transfer
    • Definition and Importance of Technology Transfer
    • The use of gated review processes
    • Tools and templates
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Steven Laurenz

Steven Laurenz,
Principal Consultant, BioPhia Consulting Inc

Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization.

Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortium.

Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistics

Barrett Rabinow

Barrett Rabinow,
Ph.D, Consultant

Barrett Rabinow was previously a Baxter Distinguished Scientist at Baxter Healthcare Corporation where he worked for over 39 years. He received his A.B. from Cornell University in 1968 and a Ph.D. in Chemistry in 1974 from the University of Chicago. From 1975-1976, he completed postdoctoral fellowships in electrochemistry, and in clinical chemistry at Michael Reese Hospital, Chicago. From 1976-1977, he served as Director, Clinical Chemistry Laboratory, Norwegian-American Hospital in Chicago. He then joined Baxter Healthcare Corporation in 1977. His positions of increasing responsibility led to the position of Director, Chemistry, where he oversaw chemistry, particle science, material science, polymer technology, and manufacturing troubleshooting for the parenterals solutions business. Dr. Rabinow has been active in industry task forces, organized by the Parenteral Drug Association, AdvaMed, Association for the Advancement of Medical Instrumentation, and the International Standards Organization as well as collaborative studies with USP, FDA, and NIH. For six years, he identified and evaluated new business opportunities, leading to Baxter acquisitions. He has developed lifecycle reformulations of drugs with new pharmacological characteristics in the area of nanosuspensions and stereoisomers. He led a team developing innovative lean stability testing protocols for parenteral solutions. Dr. Rabinow has numerous patents to his credit in the area of pharmaceutical formulations, nanoformulations, and biomaterials. He has authored four book chapters and over 40 articles, in the areas of physical-organic chemistry, clinical and analytical chemistry, trace metals, biomaterials, packaging, pharmaceutical science, drug delivery, pharmacokinetics, pharmacology and drug targeting.

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Seminar One Registration

March 30-31, 2017, San Francisco, CA
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(For Registrations till February 10, 2017 - $1599)
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Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

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Location

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(Venue to be announced shortly)

March 30-31, 2017

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