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Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions
Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.Learning ObjectivesDiscuss what to do when problems o..
Deviation Management – Investigations to Root Cause Analysis
The fundamental failure identified by regulators evolves from companies not knowing how to conduct investigations, how to identify the root cause, and how to select actions to correct the problems such that they never recur. The key to performing effective investigations is the timely gathering of all the facts necessary to understand what happened, and more importantly, what is wrong before we can begin to..
Device and Software Changes and The 510(k)
This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results-driven 510(k) / change analysis activities, based on the U.S. FDA has its current two recent “Final Guidance for Industry and FDA Staff”: “Deciding When to Submit a 510(k) for a Change to an Existing Device”; and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device..
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how Disaster Recovery and Business Continuity Planning should be carried out. This is necessary to protect against the onslaught of threats and attacks, both from natural disasters ..
Domestic and Foreign Medical Device Regulatory/Reimbursement Strategies
In general, all commercial medical devices require regulatory approval, for obvious reasons. Of equal importance, is to have a reimbursement pathway in each country where the device sale is targeted. One must get a reimbursement assessment early--while still in the product design phase. One must understand how your device may or may not fit within current payment methodologies such as DRGs, resource-based r..
Drug or Cosmetic? Promoting Health Benefits in Personal Care Products
FDA has a history of avoiding discussion of popular issues and leaving the course of history to the imagination of the industry to push the boundaries of regulatory compliance. The unwillingness by FDA to address issues like “natural”, “probiotic”, “CBD” and other popular issues, creates an opportunity to add market potential, but it also creates hazards to avoid for FDA regulated products. Assuming that di..
Drug Product Performance, In Vivo: Bioavailability and Bioequivalence
Drug product performance, in vivo, is defined as the release of the drug substance from the drug product leading to the bioavailability of the drug. The evaluation of drug product performance relates bioavailability to the therapeutic response and adverse events. Bioavailability and bioequivalence studies are measurements of drug product performance and can be used to evaluate new drug formulations, changes..
Effective and Practical use of FMEA for Risk-Based Approach to Computer Systems Validation
Validation of computer systems is a regulatory requirement within the life sciences. "How much to validate" is one of the biggest challenges validation teams face. The struggle to balance time and available resources with compliance requirements often leads to insufficient testing and/or project overruns, which in turn can lead to significant regulatory and safety risks. One way to avoid these issues is to ..
Equipment Validation, Tracking, Calibration and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces a product ..
Essentials of Root Cause Analysis for CAPA
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We’ll also cover the essentials of doing a failure investigation.Areas Covered This 90-minu..
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, but they also have the ability to change behavior, drive quality culture and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to u..
EU MDR-Introduction into The European Medical Device Regulation
The EU MDR 745/2017 is a complete game change to the old law of the MDD 93/42/EEC since 1993 with a couple of updates. The time is very short and the number of requirements and required changes is high. The training will show how to conduct a gap-analysis, an action plan and how to be on track until May 2020. Learn what to do into the quality management department and what to do in the regulatory affairs de..
EU Medical Devices Regulation: CE Mark Expiration and the EU Refusal of Your Exports
FDA and the EU have tried to harmonize device regulatory requirements for over 25 years. Major differences between the FDA and the EUincludepremarket authorization (CE Mark), complaint investigations, postmarket surveillance, and reports. The EU’s new Medical Devices Regulation (MDR) incorporates more rigorous regulatory requirements for those areas and in some cases outpaces the FDA’s requirements. The FDA..
Extractables and Leacheables in Drug Development
Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies identify potential leachables and therefore assess and mitigate the above risks based on the dosage forms and the administration route. When safety concerns are detected, approaches for the toxicological evaluation of extractable and leachable have been developed and applied by pharm..
False Claims Act (or Whistleblower Act) and Hospital Fraud
A whistleblower or qui tam action can provide financial rewards to individuals who provide information that a company, hospital, or individual has defrauded the government. The primary statutes under which this relief may be sought are the federal and state False Claims Acts (“FCAs”). State and federal governments pay hundreds of billions of dollars each year for pharmaceutical drugs, medical devices, hospi..