ComplianceOnline

Pharmaceutical dissolution testing helps to ensure the safety and efficacy of a variety of different formulated drug products. This three-day course covers the theory behind drug solubility and dissolution rate, regulatory expectations, experimental technique, interpretation of test results, investigating anomalous data, setting suitable dissolution specifications and the development and validation of dissolution tests. It also includes details of the USP and US FDA approaches for equipment qualification as well as the use of in vitro dissolution testing to establish bioequivalence. The establishment and uses of in vitro-in vivo correlations (IVIVC) will also be discussed.

The focus of the course will be on solid oral dosage forms, but apparatus and techniques for other types of drug product will also be presented, including transdermal drugs and dosage forms designed for release over a period of weeks or months. The course consists of lectures and exercises/workshops designed to reinforce the taught component.

By the end of the course, you will understand the science underpinning dissolution/drug release testing, and have the knowledge required to:

  • Avoid practical errors in the dissolution/release testing of drug products
  • Select appropriate test conditions (dissolution medium, apparatus, agitation rate, time points)
  • Validate dissolution methods in accordance with regulatory expectations
  • Reduce dissolution result variability
  • Troubleshoot anomalous results
  • Set scientifically-sound acceptance criteria
  • Implement a compliant dissolution equipment qualification strategy
  • Use in vitro data to establish bioequivalence
  • Understand the potential for establishing an in vitro-in vivo correlation (IVIVC) and the regulatory application of different IVIVC classes
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

Learning Objectives:

  • Reasons for dissolution testing
  • Factors affecting drug solubility and dissolution rate
  • Apparatus for the dissolution/release testing of different dosage forms
  • Instrument qualification approaches
  • Dissolution tests for immediate-release and modified-release drug products
  • Release testing of transdermal products
  • Accelerated dissolution testing of novel dosage forms (e.g. implants, polymeric microspheres etc.)
  • Calculation and interpretation of test results
  • Dissolution method development
  • Options for the analytical finish
  • Dissolution method validation
  • Troubleshooting anomalous data
  • The role of dissolution testing in establishing bioequivalence (biowaivers)
  • In vitro-in vivo correlation

Who will Benefit:

  • Laboratory staff responsible for developing dissolution methods
  • Personnel responsible for equipment qualification
  • Quality control analysts
  • Regulatory affairs professionals
  • Quality management
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 08:30 AM – 09:00 AM – Registration Process, Meet & Greet
  • 9:00 AM -10:30 AM
    • Reasons for dissolution testing
      • Safety
      • Efficacy
    • Dissolution testing in the context of other quality parameters
    • Dissolution theory
      • Factors affecting solubility
  • 10:30 AM -10:45 AM Break
  • 10:45 AM -12:00 Noon
    • Dissolution theory (continued)
      • Dissolution rate
      • Dissolution medium
      • Intrinsic and apparent dissolution
  • 12:00 Noon -1:00 PM Lunch
  • 1:00 PM -3:00 PM
    • Dissolution apparatus
      • Regulatory references
      • Apparatus for solid oral dosage forms (USP apparatus 1, 2 3 and 4)
      • Non-compendial options (e.g. small-volume apparatus and peak vessels)
      • Apparatus for transdermal dosage forms (USP apparatus 5, 6 and 7)
  • 3:00 PM -3:15 PM Break
  • 3:15 PM - 4:30 PM
    • Dissolution apparatus (continued)
      • Apparatus for topical semi-solid dosage forms (vertical diffusion cell)
      • Intrinsic dissolution testing
      • Ph. Eur. apparatus for medicated chewing gum
    • Requirements for different release types
      • Immediate release
      • Delayed release
      • Extended release
Day 02(8:30 AM - 4:30 PM)
  • 8:30 AM-8:59 AM Attendees arrive
  • 9:00 AM -10:30 AM
    • Requirements for non-oral dosage forms
      • Transdermal patches
      • Topical semi-solids
      • Dissolution testing for novel dosage forms
      • Experimental options
      • Accelerated release testing
  • 10:30 AM -10:45 AM Break
  • 10:45 AM -12:00 Noon
    • Interpretation of results
      • Meaning of Q
      • Results calculation
      • Immediate release
      • Delayed release
      • Extended release
  • 12:00 Noon-1:00 PM Lunch
  • 1:00 PM-3:00 PM
    • Equipment qualification
      • Regulatory/industry body guidance
      • USP approach (PV tablets)
      • US FDA approach (enhanced mechanical qualification)
      • Equipment factors influencing result variability
  • 3:00 PM -3:15 PM Break
  • 3:15 PM - 4:30 PM
    • Dissolution test troubleshooting
      • Troubleshooting approach
      • Records and observations that aid troubleshooting
Day 03(8:30 AM - 4:30 PM)
  • 8:30 AM - 8:59 AM Attendees arrive
  • 9:00 AM - 10:30 AM Method development
    • Choice of dissolution medium
      • pH range
      • Volume
      • Surfactants
      • Biorelevant media
  • 10:30 AM-10:45 AM Break
  • 10:45 AM -12:00 Noon
    • Method development (continued)
      • Apparatus
      • Agitation rate
      • Sampling points
      • Assay
      • Acceptance criteria
  • 12:00 Noon-1:00 PM Lunch
  • 1:00 PM -3:00 PM
    • Method validation
      • Regulatory guidance
      • Experimental approaches to method validation
      • Justifying acceptance criteria
      • System suitability tests
  • 3:00 PM -3:15 PM Break
  • 3:15 PM - 4:15 PM
    • In vitro approaches to bioequivalence
      • Regulatory guidance (including ICH M9)
      • Solubility and permeability
      • Measuring permeability in vitro – Caco-2 and PAMPA models
      • Oral bioavailability and first-pass metabolism
      • Limitations for in vitro bioequivalence
    • In vitro-in vivo correlation (IVIVC)
      • IVIVC classes
      • Experimental methods for establishing IVIVCs
      • Regulatory uses of IVIVCs
  • 4:15PM-4:30 PM Final questions, feedback and close
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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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$1,999.00

Seminar One Registration

June 8-10, 2020, Boston, MA
(Registrations till January 12, 2020 - $1999)
(Registrations after January 12, 2020 - $2499)




Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

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Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
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.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

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By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location :

Boston, MA
(Venue to be announced shortly)

June 8-10, 2020

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We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

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

Media Partner:

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Local Attractions of Boston, MA

Boston Public Garden

Boston Public Garden

This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

Boston Public Library

Boston Public Library

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Fenway Park

Fenway Park

Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.

Museum of Fine Arts

Museum of Fine Arts

Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.

Museum of Science

Museum of Science

The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.

North End

North End

This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.

Old North Church

Old North Church

The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.

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