Complaint Management: Best Practices to Assure Compliance and Customer Retention
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved i..
Contamination Controls for Non-Sterile Drug Product Manufacturing Facilities
This presentation is intended as an introductory overview of current industry best practices for minimizing the risk of non-sterile drug product contamination during the manufacturing process. A brief overview of the primary regulatory requirements and industry standards will be presented, (FDA, EU, ISO, ICH, USP, PDA, USP), followed by presentation and analysis of 3 differing approaches for contamination c..
Cosmetic Micro Standards, How to Stay in Compliance
What are cosmetics? Paraphrasing the FD&C Act (The Act), Cosmetics are personal care products applied to the human body for the intention of cleansing, beautifying, promoting attractiveness, or altering the appearance. The operative word here is “intent”. If your products go beyond cosmetic intentions they may also be drugs as defined under the Act: "articles intended for use in the diagnosis, cure, mit..
Critical Planning for Exporting Devices to the EU
Exporting devices to the EU has new EU legal requirements. A device must have a valid CE mark. You must renew your CE mark certification every three years. If you do not, your products cannot be marketed legally in the EU. If your product is not marketed in the U.S. Many U.S. devices are legally marketed in the EU, not the U.S., renewing your CE certification takes planning, a lot of planning. It is n..
Data Governance for Computer Systems Regulated by FDA
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a st..
De Novo Classification Process
Unlike other countries in the world, the US uses a predicate-based system to classify its medical devices. For devices that have a predicate device in the marketplace, the classification process is quite straightforward. A predicate device is a legally marketed device, called a preamendments device, that was legally marketed prior to May 28, 1976, a device that has been reclassified from Class III to Class ..
Determining a Rational HPLC/UHPLC Selectivity Starting Point
Selectivity in a liquid chromatography (LC) separation is the ability to separate a molecule from other similarly structured compounds, such as conformational, positional, and optical isomers. Columns do this in a variety of ways that depend on the structural differences between the key target molecules. This is most commonly done by tailoring the column’s stationary phase so that the different target molec..
Developing an Effective CAPA Management and Root Cause Analysis System
In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which..
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..
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..
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..