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Overview of the Training
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
▪ Pharmacopeias 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
Training Objectives/Agenda!
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
Who Are The Probable Beneficiaries of Analytical Method Validation Training Course?
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
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.
Kelly Thomas (25+ year exp.)
Vice President, Americas Quality Operations at Stallergenes Greer - Charlotte Metro USA
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.
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.
High degree of quality understanding and ability to apply knowledge of global regulatory requirements particularly with process / equipment validation, new product and technology transfer, lot/process investigations, quality systems, quality control, data trending, lab equipment and validation.
Goal-oriented and self-motivated. Committed to quality, teamwork, continuous improvement and organizational success. Ability to motivate staff and create positive, team driven, goal achieving organizations.
