Compliance Services Provided

Audits.

DefibrillatorValidation & Compliance Institute, LLC can help you find the opportunities for improvement in your compliance program. No matter which GMP’s apply in your industry VCI has an audit template which can uncover the flaws in your system. VCI's systematic approach thoroughly examines the procedures and practices in your own organization or that of a supplier. The audit protocols are specific to the industry, for instance, pharmaceuticals, medical devices, and food.

CAPA: Corrective and Preventive Action.

When an error occurs in your process, of course you will find the root cause and install a solution that will prevent the error from happening again. But do you have a system in place which encourages everyone in the plant to be looking for potential sources of problems before they happen? VCI can help you to create a work environment where employees take advantage of the CAPA process and catch errors in the system before they affect product quality. See our CAPA-RCA training.

Cultural transformation.

If your audit and gap analysis indicate widespread system failures then procedural and technical upgrades won’t lead you to full quality compliance. You need to transform the behavior of most of your workforce. Although your employees certainly need knowledge in order to make the best product, training alone doesn’t get the job done. What do people do with the binders they bring home from seminars? Are they sitting on shelves gathering dust? The concepts that they learn in their quality training need to be converted into behavior patterns; behaviors that produce quality results even when the pressure to ship product and cut costs becomes intense. VCI’s experience provides you with a cultural transformation process that, with the strong support of upper management, is a simple, yet powerful means to motivate large numbers of people.

VCI helps companies achieve a Strong Quality Culture with surprisingly low cost.  In fact, VCI's process, Positive ComplianceTM, not only produces radical improvements in compliance, it also substantially reduces costs.  For more on Positive ComplianceTM, click here.

What Are cGMPs?

Current Good Manufacturing Practices (cGMPs) are regulations that describe the methods, equipment, facilities and controls required for producing medical devices, pharmaceuticals, food, biologics, and veterinary products. FDA inspects facilities using the Quality System Inspection Technique and expects to see systems in place like Management Controls, CAPA, Design Control, and Production Controls. VCI has excellent GMP courses at several levels of intensity.

Change control.

Before you implement a change in your process you must evaluate the impact of the change on the quality of the product. You must provide documented assurance that the quality of the product will not be adversely affected by the change.

Communications with FDA.

Your communications with FDA can be critical to the success of your business. If you are responding to a 483 or Warning Letter be sure to include target dates and responsibilities. Remember that FDA is looking not only for corrections to specific observations but also to the quality systems that underlie the citation.

Design Controls.

Every manufacturer of class III, class II, and some class I medical devices must have systems and procedures for controling the design of their products. Like any activity medical device design works better if there is an established process to channel the work. FDA requires that you have a written plan for each design project; that you document initial design requirements, that you verify that the design outputs meet design input requirements; that you validate that the initial production units conform to user needs and intended uses; that the design is properly transfered to manufacturing; and that changes in design are tracked and documented. See VCI's course Introduction to Design Control. If you are developing a new medical device, let VCI's experience guide you through this heavily regulated pathway.

Deviations.

Deviations occur in the workplace, whether it is planned or not. However, any deviations that occur in the manufacturing or testing of a bulk or drug product must be documented and reviewed by management. A review of the affect of the deviation on the quality and efficacy of the product must be performed and documented by both quality and production management. This review must include any necessary steps or corrective actions that are required. Responsible personnel must be listed for each item.

Drug Master Files.

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential information about a drug. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application. DMF's are generally created to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file. An example might be a finished drug manufacturer who wants to reference information about a drug substance from another company which wants to keep their processing information confidential. VCI can write DMF's for you.

Gap analyses.

A gap analysis compares your system to the FDA requirements. What do the gaps in your program mean? Do you have some lapses in the execution of a fundamentally sound system, or are there underlying issues that manifest themselves in seemingly unrelated errors? VCI can expose those gaps and find their underlying patterns.

What Are GLPs?

Good Laboratory Practices (GLPs) are regulations that describe the requirements for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. You must have documented evidence that the quipment used for the generation, measurement, or assessment of data has been adequately tested, calibrated and/or standardized. Animal care facilities must have a sufficient number of animal rooms or areas, as needed, to assure proper: (1) separation of species or test systems, (2) isolation of individual projects, (3) quarantine of animals, and (4) routine or specialized housing of animals.

Quality Systems Regulations (QSRs).

The Quality System Regulations are detailed in 21 CFR 820, Good Manufacturing Practices for Medical Devices. As the title says it details the GMP requirements for medical devices.

Remediation plans.

After you’ve seen how your quality program compares to regulatory requirements and understand the root causes for the errors that are occurring in your process it’s time to devise a plan to bring you into compliance. A remediation plan identifies root causes for deficiencies and puts into place a system which corrects and prevents those deficiencies from re-occuring. VCI can develop your remediation plan. You can’t do everything at once. VCI’s broad experience will provide the context that you need to prioritize the improvement goals that will bring you into compliance.

Root Cause Analysis.

Does everyone in your organization understand the difference between a band-aid fix and a true root cause analysis? Do they realize that symptomatic cures are rarely cost effective? VCI can develop a root cause analysis system for you that is simple and flexible enough for employees at all levels of the organization, yet is powerful enough for even the most complicated problems.  VCI also offers training here.

Label and Market Materials Review.

Are your label and marketing claims compliant with the law? There is no surer way to get the attention of the regulatory authorities than to publish or advertise an illegal claim. Make sure that your website, labels, inserts, and advertising copy are all within the law. If you're a dietary supplement manufacturer be aware that you cannot make a disease claim on the product, such as "cures cancer, reverses diabetes or cures influenza".

Out Of Specification Results (OOS).

A laboratory may have a test result that is suspect or outside of the approved acceptance limits; that is, for release testing any result that is outside release specifications or for stability testing any result outside of stability specifications. You must have a clear procedure for handling OOS results that includes a determination of whether there was a clear, assignable laboratory cause for the anomalous result. The procedure must lead the investigators to classify the OOS result as either an analytical error, or a sample-based anomaly (including defective product) or unknown cause. The investigators must then formulate a re-test strategy.  VCI also offers training here.

Failure Investigations

Failure Investigations are performed to document the investigations and resulting actions involving a known off specification batch or Customer Complaint. Due to the compliance scrutiny that failure investigations must endure, these investigations must be thorough and complete. Therefore, a systematic approach must be applied each and every time a failure occurs.

Drug Pedigree.

The diversion of legitimate drugs and sale of counterfeit drugs is a significant drug industry problem, a law enforcement problem, and a health hazard to the American population. Although the pharmaceutical supply chain is simple in concept, the reality is far more complex. Drug containers must be traceable from the factory, through distribution, all the way to the end user. In addition the drug must be traceable at the item, or primary container level. For more information about solutions to your supply chain concerns click here to see Dr. Howe's article on Drug Pedigrees in Pharmaceutical Engineering magazine.

Risk Management.

The process of applying procedures to identify, assess, control, and monitor risks. The key to success in risk management is to make it systematic within your organization. For instance, your risk assessment SOP should define how you will insure that you will quantify the severity and probability of occurrence of any risk. FDA recognizes ISO 14971 as a reference for Risk Management procedures. Risk management is distributed throughout FDA regulations. It should be part of the first design review meeting during the design of a medical device. It should be part of Quality by Design for a drug. It should be part of the characterization of any manufacturing process before validation.  VCI also offers training here.

Call 734-274-4680 or email us at Ask VCI to find out how VCI can help you.