Dependable analytical results are essential to making a knowledgeable choice about the excellence and care of the products in the medicinal business. Additionally, such investigative data is required for supervisory submissions in the provision of the drug creation recordings. Therefore, expressive untried projects including scheme appropriateness limits must be planned for the intended use of the process.
In this course, a 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 procedures from one lab (transferring) to another 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.
In this Analytical Method Validation Training Course, the overall recommendation for the purpose of the logical features for diverse types of authentication measures is highlighted for the examination of the drug substance and drug product. The trainees will be required to pay attention to the influences to reflect for confirmation of the compendial actions that are an indivisible part of the training course. In addition, different methods for the transmission of the analytical procedures from one lab (transferring) to another lab (s) (receiving) under different conditions will be enclosed. Other related topics for obtaining reliable data will also be discussed. These themes comprise logical tool requirements as well as how to set, grip and screen specifications.
Learning Objectives
The Analytical Method Validation Training Course follows a few objectives that every aspiring candidate needs to focus on while undergoing the course:
- Drug Endorsement Process and Controlling Necessities (secluded values)
- Substitute Official methods and options
- Allowed Alterations of Chromatographic System Strictures
- Pharmacopoeias and Compendial Approval Process (public standards)
- Logical Method Life Cycle
- Investigative Method Authentication
- Compendial Coordination Procedure
- Analytical Instrument Qualifications including DQ, IQ, OQ, PQ
- Analytical Method Verification
- Analytical Method Transfer
- Chromatography System Appropriateness Necessities
- Analytical Method Validation
- How to Set Specifications and how to handle out-of-specification (OOS) and out-of-trend (OOT) results
Course Background
This Analytical Method Validation Training Course is eventually based on a new book entitled "Pharmaceutical Analysis for Small Molecules" written by Dr. Davani in 2017. Additionally, examples and case studies will be provided based on insights and widespread knowledge in emerging and applying these themes in the industry. The trainees should also get guidance and assistance depending on the interactions with the worldwide pharmaceutical industry, FDA, and other regulatory authorities.
9.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 9 credits towards a participant's RAC recertification upon full completion.
Course Content
DAY 01 (10:00 AM - 4:00 PM EST)
- Seminar objectives review, expectations, and scope.
- Pharmacopoeias and Compendial (USP) Approval Process (public standards)
- Analytical Method Validation (typical validation parameters)
- Drug Approval Process and Regulatory (FDA) Requirements (private standards)
- Chromatography System Suitability Requirements
- Compendial Harmonization Process
- Qualification Phases (DQ, IQ, OQ, PQ)
- Precision/Accuracy
- Allowed Adjustments of Chromatographic System Parameters
- Specificity
- Factors to Consider
- LOD and LOQ
- Analytical Method Verification
- Analytical Instrument Qualifications
- Analytical Method Transfer
- Linearity/Range
- FDA and USP Requirements
- Instrument Categories
- Different Approaches
- Summary and Review
DAY 02 (10:00 AM - 01:00 PM EST)
- Investigative Procedure Life Cycle
- Setting Stipulations FDA rules and ICH strategies (Q6A)
- Out-of-Specification (OOS)
- Out of Trend (OOT)
- How to handle OOS and OOT?
- Summary and Review
Course Provider
Ms Kelly Thomas,
Vice President ,
Stallergenes GreerMs. 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.
Who Should Attend
Contract Laboratories (CRO), Academia (pharmacy, Pharmaceutical Industry, Pharmaceutical, Chemistry), government (FDA or regulatory authorities),
- Quality Analysis Managers and Personnel
- Controlling Personnel
- Analytical and or Formulation Chemists
- Quality Control Managers and Personnel
- Lab Supervisors and Managers
- Compendial Liaisons
- Senior or Graduate students (chemistry, pharmaceutical, pharmacy)
- Pharmaceutical scientists/Pharmacists working in Industry
