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DR. MARK POWELLMark Powell Scientific Limited |
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September 13 – 14, 2018 |
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Zürich, ZH, Switzerland |
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In addition to the practical aspects of method validation, a logical approach to setting defendable acceptance criteria will be described. Best practices for writing methods and validation protocols will be discussed, including actions to reduce the chances of validation failure and approaches to addressing failures if they occur.
Course Objectives:
By the end of the workshop attendees will:
- Be familiar with regulatory guidance on analytical method validation
- Understand how to plan and execute a phase-appropriate method validation study
- Know how to approach setting method validation acceptance criteria
- Understand the importance of effective method and method validation documentation
- Know how to approach setting system suitability criteria
- Understand the importance of verifying compendial methods and know how to approach this activity
- Be familiar with allowable changes to method conditions for compendial chromatographic procedures
Directors, VP’s, Administrative Staff, Managers and Supervisors in:
DAY 1:
Lecture 1: Regulatory Guidance on Method Validation
- ICH Q2
- US, EU and WHO and other guidance
- Guidance on bioanalytical and cleaning verification methods
Lecture 2: Definitions of Validation Terminology
Lecture 3: Setting Validation Acceptance Criteria
- Assay, Impurities, Dissolution and Content Uniformity
- Regulatory expectations
- Consideration of drug product specifications
- Measurement uncertainty
Lecture 4: Experimental Approaches to Method Validation
- Demonstrating specificity
- Known API degradation pathway / degradation products available
- Unknown API degradation pathway / degradation products not available
- Placebo/reagent/synthetic impurity interference
- API/drug product stress study design (including peak purity evaluation)
- Demonstrating linearity Best Practice
- Accuracy and precision – spiked matrix vs. real samples
- Sensitivity
- Robustness
- Which experiments to perform?
- Setting sensible robustness criteria (including in-house IVR method)
Lecture 5: Phase-Appropriate Method Validation / Verification
- Early stage (focus on specificity, solution stability, filter recovery, logical recoveries for real samples, evaluating accuracy and precision)
- Phase 1 (focus on safety of clinical subjects)
- Late stage/commercial
Exercise: Setting Method Validation Acceptance Criteria
DAY 2:
Lecture 1: Writing effective validation protocols and reports
- Is the method ready for validation?
- Structure
- Mistake-proofing (identifying and mitigating risks)
- Results template
- Contingency planning
- Action in the event of validation failure
Lecture 2: Setting System Suitability Criteria
- Regulatory expectations
- Taking criteria from method validation results
Lecture 3: Verifying Compendial Procedures
- HPLC (including common mistakes, pitfalls and opportunities for faster analysis)
- Approaches for other techniques (pH, osmolality, viscosity and Karl Fischer titration)
Discussion: Case studies and examples
Exercise: Planning a Validation Study
He also provides training services, which are accredited by the UK’s vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.
Regular Price – $ 1500
Group of 3 Delegates – Get 10% Discount (Save $ 1260)
Group of 5 Delegates – Get 20% Discount (Save $ 2700)
EARLY BIRD OFFERS CLOSES ON AUGUST 23, 2018
Early bird seats are limited and based on first-come, first-serve.
For discounts on multiple registrations, contact customer care at +1-416-915-4458
Payment Options
Register Online:
- Make Secure Payment using Credit Card
- Click on Register Now, and you will be redirected to Payment Options page.
- Please choose your option (No. of delegates) from the drop down and click on Add to basket
- Click on Proceed to Checkout on the Cart Page, and complete the registration.
- Once the payment is completed, you will be receiving a Form to fill up the Delegates Information
- An electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date.
- Please bring the respective passes to the event venue.
Pay by Wire:
- Please contact our support to assist you with registration by Wire
- Support Number: +1-416-915-4458
- E-mail: info@webinarcompliance.com
By Check:
- Pay your check to (payee name) “FutureCorp Consulting Inc” our parent company
- Please send the Scanned copy of the check to info@webinarcompliance.com
- Mail the check to:
FutureCorp Consulting Inc
5939, Candlebrook Ct.,
Mississauga, ON L5V 2V5,
Canada - Once we receive the check, you will be receiving a Form to fill up the Delegates Information
- After payment receipt, from the registered attendee, an electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date. Please bring the respective passes to the event venue.
Hilton Zurich Airport
Zurich, Switzerland | September 13 – 14, 2018
Call for Assistance: +1-416-915-4458
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