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The selection of a new supplier can be an arduous process, and the importance of the decision is inarguable. Changing suppliers when continuous improvement recommendations fail to succeed most surely will result in high switching costs. Ultimately, the decision is worth careful evaluation, which makes a grid analysis a useful and easy tool to use.
You have just been informed by your boss that the FDA is coming to conduct an inspection of a clinical study recently completed at your facility. Does this raise your anxiety level and that of your staff to near panic levels? A FDA inspection can bring on images in your mind of a large room, bright lights and grueling questions. Probably no other agency of our government can evoke a more frightening scenario, except for maybe an IRS audit. However, with proper planning and preparation, a FDA inspection does not have to be a nightmare experience.
A big part of the cost of developing a new drug can be attributed to clinical research, which typically lasts at least eight-and-a-half years. For this reason, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are emphasizing the need to mitigate clinical-trial risks (1).
In August, I traveled to Phoenix to videotape a presentation for Natural Products INSIDER’s Digital Summit. The presentation, entitled “A Guide to SOPs and Compliance for Dietary Supplement Distributors,” goes into much more detail than our February blog post on the same subject (which you can read here:
FDA classically has defined the requirements for validation under 21 CFR 820 and 210/211 regulations as a comprehensive testing process where all systems are given thorough examination and tested under equal weight, complete with an exhaustive evaluation process. Recent guidance and initiatives by FDA (Process Validation: General Principles and Practices) and ICH (Q11: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES) have provided a streamlined risk based approach under an updated life cycle management methodology. Under this scenario, a new definition of validation has emerged, best described by FDA as “the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process is capable of consistently delivering quality products.” This is in contrast to the classical definition as perhaps best emphasized in the device regulations under 21 CFR 820.75:
From the introduction of the Guidelines for Biosimilars in the EU in 2004, Europe has been pressing hard for the introduction of these money-saving options into the marketplace. The initial guidelines of 2004 were followed very rapidly with further guidances on comparability (2005), preclinical and clinical requirements (2005), recognition of the changing landscape (2010) and in 2011, further recommendations for studies and statement of the recognition of the issues surrounding lice
Will you be prepared when tasked to write a standard operating procedure (SOP)? Writing SOPs--- shorthand for a written document that helps ensure accuracy and repeatability when executing a task---is an integral part of assembling a successful quality system. When poorly written, they are of limited value. Using the following 10 guidelines, you can create a successful SOP document.
On-the-job training is usually conducted one-on-one or in small groups so it can be challenging to confuse trainees; but fear not — when employees start a new job, they are usually a little nervous or apprehensive. They want to make a good impression and they want to be successful in learning their new tasks. This is when they are most vulnerable and they are easy pickings for total confusion. Follow these simple steps and you will have your new hires running for the hills and
All too often, quality management systems are seen as a cost of doing business – a requirement of regulators (e.g., 21 CFR 820), customers (e.g., ISO 9001:2008) or overbearing parent companies – rather than as a tool for management to effectively manage their organizations. However, quality management systems that are effectively designed, implemented, utilized and continuously improved upon provide management with quality information, delivered in a timely fashion, which facilitate data-driven decision making. Designing and implementing a quality management system that provides the appropriate information for management to make educated decisions requires careful thought and detailed planning. Once accomplished, management will have the tools to effectively allocate resources to risk-prone areas and reduce the cost of poor quality.
Dan O’Leary, president at Ombu Enterprises, LLC, started an interesting discussion on LinkedIn’s Corrective and Preventive Action Group. He was wondering where the term “root cause” came from.
Risk management is a sore point for a lot of start-ups during their product development programs. FMEAs, FTAs, ISO 14971- the sheer number of acronyms alone is staggering! I excitedly introduce you to another one – the MHL, or Master Harms List. Aligning product failures identified in risk management activities with their corresponding clinical harms sometimes becomes very labor intensive. In attempting to ensure that all relevant harms associated with a product’s component failures are captured, the engineer is presented with an expansive list of possibilities. Consumer risk is a permanent priority: thorough risk analysis is forever coupled with patient and physician safety. Drawing from multiple sources and inputs - whether from other hazard analyses, customer complaints, instructions for use or otherwise - the engineer may become overwhelmed with the plethora of available data and overlook some of the simpler and more frequently occurring harms. The preparation of an MHL gives you a leg up on the competition by giving you a “one-stop-shop” for all of your harms and eliminates the difficult task of assembling a coherent list from a multitude of sources.
This article is based on a presentation the author gave at the FoodSafetyTech Conference on May 17, 2013 in Chicago.
Do we do a good enough job at identifying the real issue or are we in such a hurry to meet a requested deadline that we simply take the word of the requestor? How do we know we are truly solving the issue and not just meeting a request?
We’ve all heard about quality management journeys or trips down the quality lane. I heard someone recently equate quality to following the yellow brick road. Quality similes are usually about pathways but this week, I read a new description.
If you’re working in the medical device industry, chances are you’ll be heading for MD&M West in Anaheim next week. MD&M West is the world’s largest medical OEM event.
Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”
Anyone who keeps an eye on the FDA’s website for enforcement actions and warning letters knows that violations pertaining to corrective action and preventive action (CAPA) are among the most common issues cited by the agency (1).
Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!
It seems like the clinical research world is often thought of in terms of pharmaceuticals. Clinical trials are often referred to in Phases, such as “a Phase 2 study of a new drug” or “a Phase 3 randomized clinical study with a placebo control.” Although clinical trials for medical devices have many similarities to those for pharmaceuticals, there are some necessary differences in the way the trials are designed and carried out. And in some cases, for medical devices, clinical trials may not even be required!
So you’ve implemented a new software system, and you’re supposed to go live with it in four weeks. It has taken you months to get to where you are: months bordering on a year. You’ve had to let some of your normal job responsibilities slide because of how much time this implementation is taking, but it can’t be much longer, right? You go through your checklist: Is the system configured the way you need it to be for your company? Check; or at least you think so. Are your documents imported and easy to find? Check; well, you can find them, but you honestly don’t know how your end users will find them. Do you have a support group at both your company and the software provider on the ready? Check; kind of. The people in your group went through the same training as you did so that means they know at least as much as you do, and you have a business card from the software trainer and the number for tech support if something goes wrong. Have you developed and distributed the end-user training? Hmmmm, no. Well, that can’t be too hard, right? Just take a couple of screenshots, write some steps, and bang—you have end-user training.
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