"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Acceptance Sampling Plans: Inspection by Attributes
Part 1 of 2 Click here for Part 2: Inspection by Variables »
Note. It is not a requirement to attend both Acceptance Sampling Plans webinars.
Acceptance sampling plans are often misunderstood and misapplied in industry. What a terrible way to introduce a subject! Unfortunately, it is true. The goal of these two webinars is to foster an understanding of the terminology and goals of acceptance sampling plans without delving deep into the statistical theory. The presenter’s “keep-it-simple” approach will avoid statistical complexity – participants do not need to have a background in statistics.
This first webinar will cover inspection by attributes – that is, parts are inspected for defects so each part is classified as either Accept or Reject. The second webinar will cover inspection by variables. In this case, inspections will result in a measurement that must satisfy a lower or upper specification limit or both.
While participants may be familiar with ANSI Standards Z1.4 and Z1.9 or ISO Standards 2859 and 3951, this webinar will motivate and provide a more straightforward methodology for application. The goal is to avoid confusing terminology, provide clear options, aid in correct application, and help participants understand the risk in their decisions.
Acceptance Sampling Plans, when used, must be based on valid statistical rationale. That is required by the FDA’s Quality System Regulation. Sampling plans can be applied for Receiving, In-Process, & Finished Device Acceptance and for Process Validation. The presentations will discuss the recommendations of the guidance documents developed by the FDA and the Global Harmonization Task Force (GHTF).
These fast-paced webinars will cover the details of application together with some examples of best practices in industry. Analysis results from popular statistical software programs will be illustrated.
The key to creating and applying Acceptance Sampling Plans is to quantify the risks involved in making a decision on the quality of a product or process. At the end of each webinar, participants will be able to:
- Define the fundamental concepts for Acceptance Sampling Plans
- Create Acceptance Sampling Plans
- Establish an appropriate sample size
- Explain the risks involved with decisions
- Quick Introduction to Acceptance Sampling Plans
- Definition of Acceptance Sampling Plans
- Regulatory Issues and Guidance Documents
- Key Considerations
- Acceptance Sampling Plans
- Introduction to Terminology
- Motivational Example
- Deriving Sample Size
- Acceptance Sampling Plan Pathway
- Summary Example of Application
Who should attend:
This webinar is targeted to professionals concerned with the application of Sampling Plans including those who wish to meet the requirements of the FDA's Quality System Regulation. The content should have great value to individuals in industry who are involved with: manufacturing, process, and quality engineering; operations; quality assurance; quality control; and regulatory compliance. Through this overview of sampling plans, managers and members of the leadership team would see how value is added to a product or process.
There are no prerequisites for these webinars. No background in statistics is necessary. That is the foundation of our "keep-it-simple" approach.
Get FREE access to Gate2GMP®, our document library and search tool.
Watch this short video to learn more about what Gate2GMP® offers »
Bring this webinar in-house?
Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?
If so, running the course in-house is probably the best and most cost effective solution.
Peter Knepell, PhD
President, Peak Quality Services
1 September 2020 CANCELLED
This webinar is offered in-house.
Click here for more info and inquiry form.
Price (excl. local VAT):
For in-house webinar, contact us for an offer.