"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Valid Statistical Techniques
for Medical Device and Pharmaceutical Firms
This 3-day, computer-based workshop provides product and process experts in US FDA-regulated firms a solid understanding of how to use valid statistical techniques for their needs. It focuses on specific methods and tools that assist with the challenges of Process Analytical Technology (PAT), Design Control, Process Validation, CAPA, and other mandated activities. The content is based on the requirements of the US FDA’s Quality System Regulation and the recommendations of the Global Harmonization Task Force (GHTF).
Industry-specific examples are provided throughout the workshop. The statistical material is covered in a practical manner. It is not over-burdened with statistical complexity. Guidelines, rules of thumb, and a very user-friendly software tool are given to foster correct, immediate, and sustained application.
Case studies (click on a topic to view an example of a case study):
- I keep hearing that we only need three production runs for Performance Qualification (PQ). Our lead Quality Engineer keeps telling me that this is wrong. Who is right?
- A competitor just received a Warning Letter from the FDA for misapplying standards for sampling procedures for inspection by attribute. We are in an acronym jungle: AQL, AOQL, LTPD, LQ, CRQ, Ac, Re, α, β, … What is important for us to do?
- For a new device we will only manufacture one device every month. How can we satisfy the FDA’s requirements for Performance Qualification (PQ)?
- The customer of our components is finding more defective items than our inspection system finds. Is there a simple way to find agreement between our inspection system and theirs?
- We perform safety-critical attribute inspections of our device but are only 90% effective. How can we improve our effectiveness?
- The FDA Quality System Regulation says that we should apply appropriate statistical techniques to detect recurring quality problems. Is there an easy way to meet this requirement? What if our quality problems are rather rare?
- How do I qualify my inspection, measuring and test equipment to satisfy FDA requirements? Do I have to do this for automated test systems?
The primary goal is for all participants to be able to immediately apply valid statistical techniques. Students are provided a Participant’s Guide and very user-friend software. The Guide is filled with examples of application. The participants will receive data files so they can work in teams to solve practical problems. Thus, the workshop stresses practical application instead of theory. A background in statistics in not required.
Participants are highly encouraged to bring a Windows-based laptop computer with MS Excel installed. Those who cannot bring a laptop will be paired with those who can so that they can benefit from the computer-based exercises
- Fundamental Concepts for Quality Systems
- Performing Process Capability Studies
- Conducting Test Method Validation (aka, MSA and Gage R&R)
- Sampling and Drawing Conclusions
- Creating Acceptance Sampling Plans
- Applying Control Charts
The content should have great value to industry professionals involved with: research and development, new product development, process development, manufacturing engineering, operations, quality engineering, quality assurance, supplier quality, and regulatory compliance. Although not required, a basic familiarity with statistical concepts would be helpful. A basic familiarity with MS Excel would also be helpful for the in-class exercises.
Equipment and software needed
A WINDOWS-BASED LAPTOP WITH MICROSOFT EXCEL IS REQUIRED.
Those who can’t bring a laptop will be teamed with those who do so that all can share in the computer-based learning experience.
A statistical software package will be provided. It is a Microsoft Excel application (SPC XL)
NOTE. This software is only compatible with Windows operating systems.
System requirements: http://www.sigmazone.com/spcxl_sysreqs.htm
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I keep hearing that we only need three production runs for Performance Qualification (PQ). Our lead Quality Engineer keeps telling me that this is wrong. Who is right?
Scenario: For a new production process we will have two identical production lines and intend to run two, 8-hour shifts. Our process engineers insist that we only have to measure the results of three batches to satisfy the FDA for process validation. They say: "We've always done it that way. Why should we change our methodology? "Our lead Quality Engineer claims that there is no valid statistical justification for three batches. It looks like we are in for a "bad stat day"...
A competitor just received a Warning Letter from the FDA for misapplying standards for sampling procedures for inspection by attribute. We are in an acronym jungle: AQL, AOQL, LTPD, LQ, CRQ, Ac, Re, α, β, … What is important for us to do?
Scenario: You are a Quality Engineer concerned with sampling plans. Several standards are given to you by the senior QE. You cannot understand them, especially the ones related to inspection by attribute. Worst yet, an internet search found an FDA Warning Letter concerning the misapplication of a related standard. After reading it, you get the feeling that the other company did not focus on risk to the end user.
For a new device we will only manufacture one device every month. How can we satisfy the FDA’s requirements for Performance Qualification (PQ)?
Scenario: We manufacture a complex, expensive scanning device. For a new model we anticipate only making one device every month. There are several critical measurements that we take before we decide that the device is acceptable. The FDA requires that we show that we can make consistent product over time. Since our production rates are so low, we feel that we cannot apply a valid statistical technique.
The customer of our components is finding more defective items than our inspection system finds. Is there a simple way to find agreement between our inspection system and theirs?
Scenario: Your company is a supplier of components to a medical device manufacturer. These components have very tight tolerances. Your company purchased several different types of expensive measurement equipment. The CMMs purchased are highly automated. Your processes have been validated and you certify the quality of everything that you ship to your customer. Unfortunately, your customer’s Quality Control group frequently rejects items for being out of specification. Your management wants a simple and inexpensive solution to this very bad situation.
We perform safety-critical attribute inspections of our device but are only 90% effective. How can we improve our effectiveness?
Scenario: We manufacture an implantable, electronic device. The device has a thin metal casing that is sterilized. We laser-etch the serial number of each device onto its casing. Sometimes the laser energy is too high and the etching cuts through the thin casing. If this happens, then the device cannot be sterilized. This is a safety-critical issue so our goal is to detect 99.9% of all defective casings. We tested our three inspectors and found that each one only detects around 90% of the defective casings. An automated inspection device can be built but will be extremely expensive.
The FDA Quality System Regulation says that we should apply appropriate statistical techniques to detect recurring quality problems. Is there an easy way to meet this requirement? What if our quality problems are rather rare?
Scenario: A company manufactures hundreds of different combination devices. An internal audit found that certain similar production steps are sometimes missed or performed incorrectly. These can affect product quality or production-line safety. The audit also found that while CAPAs were initiated, there was no trend analysis to see if these issues were recurring. Management reviews that are conducted every three months were ineffective in detecting trends. Both process and quality engineers claimed that these events were relatively rare and weekly, monthly, or quarterly trending would prove to be non-productive.
How do I qualify my inspection, measuring and test equipment to satisfy FDA requirements? Do I have to do this for automated test systems?
Scenario: Your company just purchased expensive, automated measurement equipment, called CMMs. After Installation Qualification (IQ) the supplier of the equipment claims that the CMMs are qualified and ready to be used. Your Quality Engineer (QE) says that this is not enough. She is concerned that there are more considerations beyond installation.
Pharmaceuticals and Medical Devices
Intermediate / Expert
Dr. Peter L. Knepell
Date, location and venue:
November 27-29, 2018, Copenhagen, Denmark
This course is offered in-house.
Click here for more info and inquiry form.
8.00-17.00 (Registration 07.30-08.00, day 1)
18 950 DKK (€ 2 550) incl. course material (pdf), SPC XL statistical software package, lunches and refreshments.
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.
For groups registered and invoiced together for the same course we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
Quantity disconts can not be combined with other discounts or offers.
We do not offer or practice any general company discounts without commitments and/or written agreements.
Cancellation of registration:
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.
Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.