Who Should Attend: This course is designed for Quality Control professionals who are either working on the bench, managing a laboratory or involved with a support function which routinely interacts with QC data. Quality Assurance and Regulatory Affair professionals will also find this a useful course to help them interact with the QC lab and the regulators.
Click on the titles below to learn more about each session. When live sessions are available, sign up anytime during the 12-session live course! You will receive recordings of past sessions and invitations to join upcoming live sessions. Or sign up to receive links to recordings of any or all sessions from the previous 12-session course.
Although designed to be taken in a series, you may pick and choose individual sessions, as they are designed to be stand-alone units. When you are ready, click on the “Register Now” button to sign up for individual sessions or the full course. Each live session is interactive: Login, listen, learn and ask questions!
Each 90-minute session is just $362 per session or $3985 for all twelve sessions! Great group discounts are available.
The next live, 12-session course will begin in October 2020. Sessions are scheduled approximately every two weeks through April 2021.
FREE WEBINAR! The on-demand recording of Session 1: Regulations & Regulatory Trends is available for FREE! Click HERE to watch Session 1 anytime.
Content: Regulations and Regulatory Trends and how they impact QC professionals on a daily basis. This session provides an overview of the GMPs as they pertain to the quality control professional. It serves as both an introduction to those new to the field and as a refresher for those with more experience.
Content: How to handle QC Laboratory Equipment. As mentioned in session 1, there are regulatory as well as good scientific practices which mandate how you are to handle all equipment which are used in the QC laboratory. This session covers both the qualification of instruments before they are used, and the required metrology practices. We will discuss documentation, implementing programs in new labs, labs with legacy equipment and how to handle unusual equipment.
Content: Analytical Rare Reagents are a keystone to keeping your methods working for the long term. Unfortunately it is overlooked by many firms. We will cover the regulatory requirements for tracking, testing and releasing analytical reagents for use in the QC department. As part of this we will discuss different approaches for specialty reagents vs. USP grade material.
Content: Review of Basic Statistical Tools needed in the QC laboratory. As a QC professional you are required to understand and implement some basic statistical calculations. This course won’t dwell on concepts you won’t need, but this session provides a refresher of basic concepts you will need in moving forward. We will discuss some basics such as normal distribution, when you should transform your data if it is not normally distributed, how to determine required sample sizes, and remind you about confidence intervals vs. tolerance intervals. All this will occur in terms geared for the lab scientist rather than the statistician.
Content: Specifications and System Suitability Criteria are the two operating numbers which are routinely included on the final Certificate of Analysis. This session will talk about the two and how they protect both you and the patient. We will discuss how they are established, when and what the legal, as well as practical, implications of the two.
Content: Statistical Process Control Charts are at the core of maintaining any product or analytical method for its entire lifecycle. This is a primer for process control charts, how they typically set up and used in a QC environment. By the end of this session, you will be able to start monitoring your methods in a statistically appropriate and practically relevant way.
Content: Understanding Specifications and the Use of Capability Analyses to determine expected “false-alarm” OOS rates. Out of specification (OOS) events are the single most disruptive occurrence in the QC lab. Yet, since many of our specifications are initially established using a very small number of batches, we often find that based upon the precision of a method – there will be an expected number of lots, which are “typical” lots which will fail a specification. We will discuss how to determine the expected outlier rate and what we can do to improve the method precision to decrease these problems.
Content: Despite having our equipment qualified and calibrated, our reagents released and a system suitability tracking in place, occasionally, there will be OOS events. These events will need to be investigated. These are formal investigations which have two parts: A laboratory investigation and, then, a product investigation, if necessary. Much regulatory action happens around these investigations. We will discuss the regulatory requirements, how to implement and conduct excellent lab investigations, and what are the requirements from a QC perspective for a product failure investigation.
Content: Many of our new product developments are happening using concepts from QbD. An underpinning of this approach is the use of “Design of Experiments” (DoE). We will cover the basics of DOE and show how it can be applied to analytical methods. This important tool can be used for trouble shooting, method transfer and validation. It is a tool that every QC professional should have in their arsenal. We will use inexpensive off the shelf software to explore case studies and show you how to use it to understand your methods.
Content: The regulatory requirements of both ICH and Quality by Design approaches will be covered. In the 1990’s, a major shift in the approach to validation happened with the writing of the ICH validation guidelines. These principles are still required. However, Quality by Design has given us some additional tools for validation. These help us validate methods and choose appropriate assay formats (replication schemes etc.). This session will cover both the tried and true ICH basics and cover the QbD approaches which utilize elements of Design of Experiments (DOE) approaches.
Content: This session covers what is required to transfer methods from one lab to another. This includes the different regulatory requirements for compendial versus non-compendial methods. The sampling plans and approaches to data analysis needed to demonstrate equivalency will be covered.
Content: The final session will review Recent Regulatory Audit Results. These will highlight findings in the Quality Control laboratory. By this time, you will be nodding your head and understanding many of the problems revealed by the audit and how companies could have avoided these dangerous pitfalls, if only they had taken this course!
COPYRIGHT: U.S. Copyright Law protects the program you are about to attend from unauthorized duplication. Multiple participants are not authorized to share access provided to a single registrant. For each individual who attends, a single dedicated seat license must be purchased, or a group rate must have been previously arranged with FasTrain. FasTrain reserves the right, at its discretion, to cancel or interrupt access to a web-based training class without notice, or to invoice and collect the group rate payment for the class from the single registrant if this requirement has been violated.
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