Reliable analytical results are necessary to make informed decision about the quality and safety of the products in the pharmaceutical industry. In addition, such analytical data are required for regulatory submissions in support of the drug product registrations. Therefore, meaningful experimental designs including system suitability parameters must be planned for the intended use of the procedure.

In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures is highlighted for the analysis of both the drug substance and drug product. The factors to consider for verification of the compendial procedures will also be discussed. In addition, different approaches for the transfer of analytical procedure from one lab (transferring) to other lab(s) (receiving) under different circumstances will be covered. Other related topics for obtaining reliable data will also be discussed. These topics include analytical instrument qualification as well as how to set, handle and monitor specifications.

Due to global nature of pharmaceutical industry, other quality topics on both regulatory (ICH) and compendial (USP) harmonization are also covered. These topics are valuable for scientists directly or indirectly involved with the drug development, analysis. stability studies or regulatory/compendial submissions.

Learning Objectives:

  • Drug Approval Process and Regulatory Requirements (private standards)
  • Pharmacopeias and Compendial Approval Process (public standards)
  • Compendial Harmonization Process
  • Chromatography System Suitability Requirements
  • Allowed Adjustments of Chromatographic System Parameters
  • Analytical Instrument Qualifications including DQ, IQ, OQ, PQ
  • Analytical Method Validation
  • Analytical Method Verification
  • Analytical Method Transfer
  • Alternative to Official procedure and options
  • Analytical Procedure Life Cycle
  • How to Set Specifications and how to handle out-of-specification (OOS) and out-of-trend (OOT) results

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • Certification

Who will benefit:

Pharmaceutical Industry, Contract Laboratories (CRO), government (FDA or regulatory authorities), Academia (pharmacy, Pharmaceutical, Chemistry)

  • Analytical/Chemists
  • Formulation Chemists
  • Lab Supervisors and Managers
  • QC Managers and Personnel
  • QA Managers and Personnel
  • Regulatory Personnel
  • Compendial Liaisons
  • Pharmaceutical scientist/Pharmacists working in Industry
  • Senior or Graduate students (chemistry, pharmaceutical, pharmacy)

Course Background:

This course is based on a recent book entitled "Pharmaceutical Analysis for Small Molecules" by Dr. Davani which was published by Wiley in 2017. In addition, examples and case studies will be provided based on insights and extensive experience in developing and implementing these topics in industry/pharmacopeia. Guidance and advice will also be provided based on interactions with global pharmaceutical industry, FDA and other regulatory authorities worldwide

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(9:00 AM - 4:00 PM EST)
  • 9:00 AM - 10:00 AM:
    • Seminar objectives review, expectations and scope.
    • Drug Approval Process and Regulatory (FDA) Requirements (private standards)
    • Pharmacopeias and Compendial (USP) Approval Process (public standards)
  • 10:00 AM - 11:00 AM:
    • Compendial Harmonization Process
    • Chromatography System Suitability Requirements
    • Allowed Adjustments of Chromatographic System Parameters
  • 11:00 AM - 12:00 Noon:
    • Analytical Instrument Qualifications
    • Instrument Categories
    • Qualification Phases (DQ, IQ, OQ, PQ)
  • 12:00 Noon - 1:00 PM: Lunch
  • 1:00 PM - 2:00 PM:
    • Analytical Method Validation (typical validation parameters)
    • Specificity
    • Precision/Accuracy
    • Linearity/Range
    • LOD and LOQ
  • 2:00 PM - 3:00 PM:
    • Analytical Method Verification
    • FDA and USP Requirements
    • Factors to Consider
  • 3:00 PM - 4:00 PM:
    • Analytical Method Transfer
    • Different Approaches
  • 4:00 PM - 4:30 PM:
    • Summary and Review
Day 02(9:00 AM - 12:00 PM EST)
  • 9:00 AM - 10:00 AM: Analytical Procedure Life Cycle
  • 10:00 AM - 11:30 AM:
    • Setting Specifications FDA regulations and ICH guidelines (Q6A)
    • Out-of-Specification (OOS)
    • Out of Trend (OOT)
    • How to handle OOS and OOT?
  • 11:30 AM - 12:00 Noon: Summary and Review
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Kelly Thomas

Kelly Thomas
Head Of Quality Assurance, Veru Inc

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

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$1,499.00

(One Dial-in One Attendee)

December 8-9, 2021, Virtual Seminar
(Registrations till October 30, 2021 - $1499)
(Registrations after October 30, 2021 - $2099)

$7,695.00

Group-Max. 10 Attendees

December 8-9, 2021, Virtual Seminar
(Registrations till October 30, 2021 - $7695)
(Registrations after October 30, 2021 - $9865)



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