Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed.
This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction.
The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias.
Because certain requirements in 21 CFR part 211, which implement § 501(a)(2)(B) of the FD&C Act, were directed at the commercial manufacture of products typically characterized by large, repetitive, commercial batch production (e.g., those regulations that address validation of manufacturing processes (§ 211.110(a)), and warehousing (§ 211.142)), they may not be appropriate to the manufacture of most investigational drugs used for phase 1 clinical trials.
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.
This session covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.
This webinar will discuss FDA's criteria for acceptance of foreign clinical trials whether conducted under an FDA submission or not conducted under an FDA submission. Clinical research is becoming increasingly global. FDA recognizes Sponsors may decide to use clinical data that is obtained from foreign sites to support clinical investigations and/or marketing approval in the USA. Some Sponsors may even seek to rely solely on foreign clinical data for an FDA investigational or marketing application. This webinar will review criteria for FDA acceptance of foreign clinical studies/data.
US Food and Drug Administration (FDA) now requires electronic submission for labeler code requests, drug establishment registrations, drug listings, annual renewals, and updates. The electronic process replaces FDA paper forms 2656 (Registration of Drug Establishment/Labeler Code Assignment), 2657 (Drug Product Listing), and 2658 (Registered Establishments' Report of Private Label Distributors).
The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously.
Organizations eligible for Meaningful Use incentives, and Accountable Care Organizations, are financially incented to use electronic health records systems or effectively for their Medicaid and/or Medicare populations. But many organizations considering these options have questions about the risks, implementation, and potential for savings under these programs. Established ACOs and organizations already implementing Meaningful Use may have questions about how to leverage existing EHRs or personal health devices to improve efficiency and effectiveness.
Heat sterilization is a PROBABILTY function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms. Current regulations expect the sterilization process to provide a level of assurance of at least 1 x 10-6 probability (fewer than one non-sterile unit per million units) of survival (non-sterility) for terminally sterilized parenterals and medical devices. Since Regulations require that we generate in our sterilization processes a PROBABILITY of a NON-STERILE UNIT (PNSU), how do we use D-values, Z-values and Fo to calculate the probability and determine that we have essentially zero risk in our products due to lack of sterility?
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR?
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 Development of veterinary biologics, involves a complex series of clinical studies and analytical programs to assure the quality and effectiveness of these products. Biologicals are commonly vaccines and include conventional viral based products, bacterins, toxins, rDNA products and antibody products.
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.
This webinar will discuss a voluntary process for qualification of Medical Device Development Tools (MDDT) for use in device development. An MDDT is a scientifically validated tool (test) to determine clinical outcome. Qualification reflects CDRH (FDA's) expectation that within a specified use the results of an assessment that uses an MDDT can be relied upon to support device development and regulatory decision-making.
Safety professionals, managers, operations executives, and Senior Leaders are under moral, legal, and financial obligations to establish workplaces that are safe and run efficiently. At a very practical level, however, a disconnect between regulatory (legal requirements) and safety is very obvious.
A brief description of the FDA groups that are responsible for approving new drug products is reviewed including how one group works with another. This webinar will describe how drug development works in a pharmaceutical company for those students who do not have this experience. The common steps that companies take to develop drugs are described along with documents that are required along this journey. The logistics of interacting with the FDA are described including what the company needs to accomplish to be successful at the meeting.
This session will introduce the basic concepts, the expanding collection methods (the internet of things, drones etc.) and the role of industry standards and simple quality management (e.g., Six Sigma) to document near-misses and good catches using data tools. The need to address privacy issues with patients' customers' or grower's confidential data will be paramount to ensure a cooperative flow of information for performance-enhancing analysis of "big data". In pharmaceutical industry settings, a "Big Data community" brings together the Big Data pioneers who share insights and exchange ideas about its proper use.
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.
Manufacturers of APIs, Final Drug Products and Medical Devices are required to report to the FDA when they learn that any of their products may have caused or contributed to a death or serious injury or if there is an anticipated patient risk. Manufacturers must report to the FDA when they become aware that their product may or has malfunctioned and would be likely to cause or contribute to a death or serious patient risk. The FDA's regulations contain mandatory requirements for manufacturers, importers, and device user facilities to report certain product-related adverse events and product problems to the FDA.
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. There will be a review of the corrective and preventive action requirements. We will cover how corrective actions should be used throughout your Quality Management System. Definitions of Correction and corrective actions, their differences and importance will be covered.
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry.
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer.
This webinar will address the complexity of defining safe food and examine the factors that impact on microbiological food safety. We will look at the changing nature of foodborne/food transmitted pathogens and the influence of demographics and geography on the changing landscape. The webinar will also discuss roles and responsibilities for mitigating food contamination and foodborne illness.
This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices.
A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.
Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained.
In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost effective.
Water system validation is often considered a necessary evil intended to merely satisfy a regulatory expectation. If done using a one-size-fits-all template, it probably satisfies regulatory requirements but is indeed a waste of time when it could be a valuable "insurance policy". All water systems are different and have different challenges in consistently purifying and delivering acceptable water to users.
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.
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.
Course "Better Alternatives to Sampling Plans" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health.
Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors.
Intentional contamination or adulteration of food is a reality. We will review some examples of the dire consequences of adulteration ostensibly for economic gain This webinar will also discuss the potential threats of using food as biological weapon and the actions food companies can take to mitigate and minimize the risks of food bioterrorism.
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background.
The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.
This webinar explains the issues and techniques that regulators may use when investigating your water systems for "GMP flaws". More than likely, even the most quality-conscious organization has some water system "skeletons" in their closets, perhaps unwittingly. These "skeletons" or deficiencies are often connected with the site’s Quality Systems and are indicative of your Quality Systems health, so having an uneventful water system audit (which would be facilitated by attending this webinar and proactively addressing the issues presented therein) could keep the regulators out of other typically fertile territory for regulatory deficiencies found elsewhere at your site.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception.
A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer.
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 12 months FDA issued more than 10 warning letters with citations Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA.
Reliability Plotting is a graphical technique that is a standard method described in some reliability textbooks. The method is used primarily for data that is problematic in one or more of the following ways: non-normal (e.g., a Fatigue-Life distribution), a mixture of distributions (e.g., the distribution looks bi-modal when arranged into a histogram), low precision (e.g., a large number of identical readings in a small sample size), and/or incomplete (e.g., when a study is terminated before all on-test devices can be measured, due either to measurement equipment limitations or due to time limitations). Reliability plotting can easily handle all such situations.
Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success.
Sterilizing filtration, utilizing membrane filter often of 0.2 micron rating, are critical in aseptic processing. As soon as heat sterilization cannot be used or bioburden requires to be reduced before heat sterilization, sterilizing grade filters are installed to remove the microbial burden.
Many laboratories regard Quality Assurance, Quality Assessment and Quality Control as independent activities, others use the terms interchangeably, e.g. QA/QC. This demonstrates a lack of appreciation of the differences between Assurance, Assessment and Control, as well as the interrelationships, particularly between QA and QC. This has created confusion in the minds of many analysts with respect to understanding how QA and QC play separate, but related roles for achieving Quality Assurance in a Quality Management System (QMS).
Supplier qualification and assessment is required in both the QSR regulations and ISO standards.
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.
What is a combination product? What are some examples of combination products? How are combination products assigned for review?
Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?
Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization chemical choices and how they are used, as well as the frequency of the sanitization process have everything to do with its success.
Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction.
Many microbiology laboratories are confused about what MU is, how to calculate it and how to apply it. We will discuss what is needed to meet the accreditation requirement for MU, including, what data to collect and how to analyze it. Also a practical step by step approach to data compilation specifically applicable to microbiology will be discussed.
During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.
Laboratory water systems are often the forgotten, red-haired stepchild of pharmaceutical operations. Yet, in some ways, the maintenance of the appropriate quality of lab water systems is perhaps more important than many applications of manufacturing's water systems since the tests performed on manufacturing's products can be affected by the lab water quality in insidious, hard to detect ways, which could cause perfectly good products to appear to fail testing or bad product to appear to pass. Often too little effort is invested in understanding and maintaining lab water systems for a number of reasons that will be discussed. On the other hand, excessive effort may be expended in maintaining certain water attributes that are neither required nor consequential for the vast majority of analyses, such as the microbiological content.
The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company's personnel every day.
This webinar will provide valuable assistance to all regulated companies, since personnel training is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.