This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained.
Post Market Surveillance (PMS) is the practice and system of monitoring the safety of a medical device after it has been released on the market. It relies on several foundations including unique device identifiers (UDI),electronic health records and medical device reporting, device registries, and advance methods for evidence generation and data analysis.It is a system that continues to develop and improve.
This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective clinical studies in the U.S. and EU.
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Under 21 CFR 3.2 (e), a combination product is defined to include:
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.
Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that explores either natural variation or introduced variation in a process and shows that the process can consistently produce a quality product.
A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also effectively correcting problems when incidents do occur and as part of the Continuous Quality Improvement program, correcting potential problems prior to occurrence. Adequate incident tracking is the primary foundational element for an effective CAPA system.
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
The topic is changes in the IVD area, and how they may affect your business or practice. We will review FDAs draft plans for MDUFMA, the LTD vs,IVD issue, the approach to globalization embodied in the proposed acceptance by FDA of the IMDRF Software guidance, the drug and medical device development tools programs (biomarkers), Software as clinical decision assistanceand Multi-Analyte tests such as DNA NGS.
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Written procedures are to be established and followed for a time efficient and clear evidence of the quality related elements during the review and approval for release, including packaging and labeling, to determine compliance of the intermediates (FDA definition) and/or finished product with established specifications before a batch can be released for distribution BPRs, DHRs and laboratory control records for critical process steps are to be reviewed and approved by the quality unit(s) before a finished product batch is released for distribution. Production and laboratory control records for earlier, non-critical process steps may be reviewed by qualified production personnel or other units following procedures approved by the quality unit(s).
This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device.
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation.You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management.We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
Human Factors Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating theeffectiveness of the studies will be explained. The various types and methods of human factors analysis will beexplained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.
There is confusion between the requirements for Design Verification, Process Validation and Design Validation. While each of these processes has its own requirements, they do not stand alone, they are linked together. As this linkage is not well understood, it is the source of FDA observations and potential release of products that do not meet requirements.
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
This presentation is intended to help manufacturers implement cGMP quality systems and risk management approaches during commercial development and operations after the initial preclinical studies, to meet the requirements of the FDA's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211).The FDA requires comprehensive quality systems highlighting the company's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs as well as medical devices, including biological drug products. This program also explains how manufacturers implementing good manufacturing practices managed by quality systems can be in the best compliance with parts 210 and 211.
Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world"
The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).
Normality Tests and normality transformations are a combination of graphical and numerical methods that have been in use for many decades. These methods are essential to apply whenever a statistical test or method is used whose fundamental assumption is that the inputted data is normally distributed.
Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes leading to 483s and even warning letters. This webinar can help you be more professional and polished during an inspection. You will learn how to present information about your quality system in the most competent and professional manner.
This webinar explores the science and art of lyophilization and discusses how the lyophilization cycle and process is developed and validated, along with the regulatory requirements for lyophilization.
Lyophilization cycles consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained. During the freezing phase, the goal is to freeze the mobile water of the product. Significant supercooling may be encountered, so the product temperature may have to be much lower that the actual freezing point of the solution before freezing occurs.
Many medical device companies are surprised when they have a recall, a 483, warning letter or even a consent decree. Yet, all medical device companies follow the same regulatory requirements.So why are some companies more successful than others in terms of quality and compliance? This webinar will explore the seven capabilities every company needs to master in order to succeed in the future. We'll discuss how to evaluate yourself and develop plans to improve your capabilities. You'll learn how to use maturity modeling to develop your Quality and Compliance Strategy.
The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA). Computer software was in a state of infancy during the 1970's and the role computer software would eventually play in the provision of healthcare was not foreseen.
Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document.
This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements are discussed and the reasoning behind them.
Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation - that is, no two items are identical. What method can we use to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".
Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.
In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.
This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations. The deviation process is explored and evaluated and examples are given to demonstrate the best way to handle deviations and subsequent CAPAs. Attendees will have the opportunity to interact and ask questions about best practices regarding both devotions and the CAPA process. Reasons for having a robust deviation process are given with examples.
Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording. This 60 min Webinar will discuss the proper timing and wording to use for the 483 response to put your company in the best position with the FDA. FDA policy and goals regarding the 483 response are discussed. Examples of both good and poor responses are given. Warning Letters and responses are discussed and the implications of both a good and poor response to a possible Warning Letter are given. The standard format of the 483 response is given along with an explanation there of.