Specifications for Chemical Drug Products

    Specifications for Chemical Drug Products

    12-14 March 2024, live online training


    The specifications applied to drug products and raw materials used in the production of medicines are important elements in safeguarding patient safety and ensuring drug product efficacy.  Regulators will expect to see proposed specifications in a drug product marketing application that control important quality attributes within suitable limits.  The purpose of this course is to help applicants to decide which attributes to control in written specifications and how to approach setting appropriate values for each parameter, both at release and over the shelf life of the product.  Topics include current regulatory guidance, including upcoming changes, using risk assessments to control attributes such as residual solvents and elemental impurities, specifications for selected novel dosage forms, justifying new impurities in generic drug products, and the control of genotoxic impurities.  An important element to consider in the control of pharmaceutical materials is the suitability of the test methods used for each quality attribute.  Recent USP and ICH guidance suggests that regulators will focus on this area in the coming years, and this important topic is covered in the course.  Each day will include a workshop that will reinforce the learning points.

    Learning Objectives

    • Current regulatory expectations
    • How to set meaningful specifications for raw materials and drug products
    • Using the principles of quality risk management for impurity control
    • Avoiding common errors and omissions

    Key Topics

    • Regulatory guidance
      • Specifications (ICH Q6A)
      • Impurities (ICH Q3 family of guidance documents)
      • Genotoxic impurities (ICH M7)
    • Risk assessments for residual solvents, elemental impurities and extractables
    • Excipient specifications
    • Control of drug substance vs. drug product
    • In-process specifications and parametric release
    • Release vs. shelf life specifications
    • Specifications for specific dosage form types
      • Oral liquids/solids
      • Parenteral drug products
      • Topical drug products
      • Inhalation drug products
      • Liposomes
    • Justifying new impurities in generic drug products
    • Test method suitability
    • A risk-based approach to the control of genotoxic impurities

    Who should attend?

    Analytical Development Scientists, Pharmaceutical Development Scientists, Quality Control Personnel, Quality Assurance Professionals, Regulatory Affairs Specialists, Project Managers, Process Development Scientists, Consultants

    Our online training experience includes

    • Our client zone – a single source for all training materials as well as pre and post-training communication
    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 7 days
    • Training in digital format
    • Digital and LinkedIn certificates


    Dr Mark Powell
    Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016.

    Specifications for Chemical Drug Products

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 2 073 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate

    Price per delegate including:

    Online participation

    Recorded sessions for 7 days

    Online workbook & materials


    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori

    +421 222 200 543

    Training Details
    • Start Date
      12. March 2024
      09:00 AM Vienna time
      08:00 AM London time
      04:00 AM New York time
      01:00 AM Los Angeles time
    • End Date
      14. March 2024
    What participants said about Symmetric courses

    "It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."
    Tech Transfer Lead, Novartis

    "Practical examples were extremely useful and well presented."
    Senior Development Specialist, Bioton

    "Diving into the case studies and the ensuing discussion and learnings were great."
    Regulatory Affairs Specialist, Csl Behring

    "Excellent work of the lecturer, good materials, clear explanations."
    Clinical Pharmacologist, Boehringer Ingelheim

    "You succeed only when you are trained enough! Trust Symmetric's Training Team to achieve your goals."
    Analytical Developer, Gedeon Richter

    "Thank you for sharing all the links and informative material. Very professional organization and execution."
    Manufacturing Manager, Thermo Fisher Scientific

    "Very well organized event. Thanks and hope to work-learn from you again soon."
    Deputy Manager of Solid Dosage Forms Plant, Gedeon Richter

    "Many thanks for the invitation, organization of the training and the atmosphere. I found the course very well organised and presented."
    Formulation Manager, Curia