Assay Validation by Design - New Course
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Individual Registration
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Time: 8:30 a.m. - 4:00 p.m.
Pharmaceutical assay validation is both a good business practice and a requirement of the current Good Manufacturing Practice Regulations. This introductory course presents assay validation as specified in the ICH guidelines, USP, FDA documents and the literature.
Completion of this course will enable participants to plan, design and analyze data collection protocols to develop and improve chemical assays while also collecting the data needed to validate to the USP and ICH requirements. Additionally, participants will be able to design, execute, and report a statistically consistent validation of an analytical method including considerations such as accuracy, precision, specificity, limit of detection/limit of quantitation/linearity and range, and robustness and ruggedness.
Who Should Attend
This introductory seminar is for those working in chemical assay validation. It is intended for analytical laboratory chemists, supervisors and managers. Validation engineers, quality control/assurance personnel and others with an interest or responsibility for validation will likewise benefit.
Prerequisites
It is recommended that the participant read ICH Q2 (R1).
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Day 1
Upon completion of this course, you will be able to:
- Design an assay validation that uses Plackett-Burman DoE’s to demonstrate ruggedness with fewer experiments than the typical assay validation runs
- Identify the sources of variation in a method
- Quantify the best case and a worst level of variation
Continuing Education for Pharmacists
PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:
PDA #319 | ACPE #0116-0000-18-022-L04-P | 0.6 CEUs
Type of Activity: Application
Continuing Education for Professional Engineers
New Jersey
PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.
The credit value of this course is 6 CPC credits.
North Carolina
PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.
The credit value of this course is 6 PDHs.
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PDA Training and Research Institute
4350 East West HighwayBethesda, MD , United States
Jason J. Orloff, Statistical & Engineering Consultant, PharmStat
Jason J. Orloff, Ch.E. & M.S. Applied Statistics is a Principal Statistical Consultant at PharmStat and a proud colleague of Lynn Torbeck. He is an international consultant specializing in applied statistics and experimental design for pharmaceutical and biopharmaceutical development, quality assurance, quality control, validation, and production under the cGXP's. Current activities include an author of ISPE’s Baseline Guide for Q10 chapter “Process Performance and Product Quality Monitoring”, contributing authorship of the PDA’s Technical Report 59 on “Utilization of Statistical Methods for Production and Business Processes”, and publications in the Journal of Pharmaceutical Technology. Mr. Orloff brings over ten years of experience in manufacturing, quality, and regulatory affairs in the pharmaceutical industry. Areas of expertise include PAT, OOS, SQC, SPC, assay validation and setting specification criteria. A Chemical Engineer with real-life expertise at applying statistics in a highly regulated environment, Mr. Orloff is able to work effectively across all levels of an organization as well as make high level concepts accessible to a variety of audiences. Mr. Orloff has worked with a wide variety of companies including pharmaceuticals, parenterals, biotechnology, fine chemicals, medical devices, food, and nanotechnology. He holds a BS in Chemical Engineering from UW-Madison and an MS degree in Applied Statistics from DePaul University.