Course Description

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

Agenda

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

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


Choose a Pricing Option

$1,295

Early Bird One Dial-in One Attendee - Live

Early Bird $1295 Regular Price $1985

You get one log-in for the live virtual seminar for one participant, presentation materials , Certificate and the opportunity to ask questions by phone and email.

$3,995

Corporate Live Group 5 Attendees

2 Days Virtual Seminar

You get 5 log-in for the live One and a Half Day Virtual Seminar for all the participant, presentation materials ,DVD , and the opportunity to ask questions by phone and email. Recorded Access for 12 months is Included .

$1,498

On demand Recorded Access Single User Access

2 Days Virtual Seminar

You'll have Group access to log-in for an archived recording of the entireOne and a Half Day Virtual Seminar

for 12 months, including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$3,998

Corporate Group On Demand 4 users

You'll have 12 month group access to log-in for an archived recording of the entire One and a Half Day Virtual Seminar

, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

FDA Faculty Kelly Thomas

Faculty Kelly Thomas

Vice President, Americas Quality Operations at Stallergenes Greer

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.