ComplianceOnline

Decisions made during the preclinical and early clinical phases of a drug development project can determine the regulatory acceptability of the application to market a new or generic drug. This one-day course provides attendees with an overview of the important steps in the development of a solid oral drug, from the point at which the chemical and polymorphic properties of the active ingredient have been decided to the manufacture of material for early-stage clinical evaluation.

The course focuses on tablet and capsule dosage forms and covers the important steps in formulation, process and analytical development. It also covers options for primary packaging and suggestions for improving product stability in blister and bottle packs. The role of stability evaluation under real-time, accelerated and stress conditions will also be discussed.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

  • Understand the expectations of regulatory reviewers in relation to solid oral dosage forms
  • Be able to judge the acceptability of dissolution methods based on drug release type and API solubility
  • Understand the relative benefits and disadvantages of tablet and capsule dosage forms
  • Appreciate the significance of important material properties (powder flow, behaviour during compression etc.)
  • Understand the role of each component in a formulation and how to evaluate chemical compatibility
  • Appreciate the importance of suitable analytical methods during early-stage development
  • Know how to choose between direct compression and wet/dry granulation processes for tablet development
  • Understand how to evaluate the tabletability of a formulation
  • Be able to develop strategies to achieve target release profiles
  • Appreciate the reasons and options for film and functional coating
  • Be able to design appropriate development stability studies
  • Understand the factors affecting the choice of primary packaging

Who will Benefit:

  • QA managers and personnel
  • Formulation development personnel
  • Laboratory managers and analysts
  • Production managers and operators
  • Project managers
  • Regulatory affairs professionals
  • Consultants
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Day 01(8:30 AM - 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  • Module 1 – Regulatory Requirements
    • Overview of US and EU requirements for solid oral dosage forms
    • Product development and the common technical document
    • Types of release
    • Biopharmaceutics/developability classification systems
  • Module 2 – Formulation and Analytical Development
    • Analytical methods required to support product development
    • Dissolution method requirements
    • Excipient types and roles
    • Evaluating excipient compatibility
    • Powders and powder flow
    • Granules and wet/dry granulation
    • Drying
    • Tablets and capsules – overview and comparison
    • Modified release formulations
    • Coating
  • Module 3 – Tableting
    • Deformation mechanisms of solid materials
    • The tableting process
    • Direct compression or granulation?
    • Tooling options
    • Common problems – capping, lamination, sticking and friability
    • Hardness and tensile strength
    • Scale-up and strain rate sensitivity
    • Compaction simulation
  • Module 4 – Packaging and Stability Evaluation
    • Packaging options for tablets and capsules
    • Oxygen and moisture vapour transmission rates of typical materials
    • Options for improving stability
    • Designing development stability studies
    • Stability evaluation – interpreting stress, accelerated and real-time data
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Mark Powell

Mark Powell
Director, Mark Powell Scientific Limited

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

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Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

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.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

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For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

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Kunsthaus Zurich

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Limmat River

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Zurich Old Town (Altstadt ) is a cultural, social and historical melting pot. The highest concentration of clubs in Switzerland, one of the most famous shopping miles, and a plethora of cultural offerings

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