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.
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 interactive webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance.
Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success.
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.
Information provided will allow an attendee to determine if their App is a medical device, and if it is, determine the regulatory obligations the App will carry. Guidance will also be provided as to adjusting the intended use claims for an App that might take it out of the definition of a medical device. Recommendations will be provided for getting started with medical device regulations if your App is a medical device.
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.
Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. Software may be a standalone device, control a device's performance, make calculations, identify treatment options or begin to play a more active role in making clinical decisions regarding patient management and treatment.
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?
This course will focus on teaching how to efficiently and effectively apply recommended statistical methods and tools to process validation. Using hands-on exercises (complete with realistic process data), participants will learn how to apply these tools, interpret results, and draw meaningful conclusions throughout Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Quality Systems are the bench mark of the medical device and pharmaceutical industries. It is a practice recognized both internationally and domestically. Technically in way or another we have always these but they may not have been categorized as such.
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.
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.
The proliferation of legal requirements (law and regulation) governing the financial relationships between medical product companies and the doctors who order their products has led to what can only be described as a tangled mess. Many device companies have had to add personnel, or employ expensive consultants in order to have a hope of complying.
Statistical Applications - Use of a statistician or person with adequate statistical training (not just 6 Sigma) to develop the experimental design and the statistical methods / models needed to measure and evaluate process capability, uniformity and on-going stability.
Course attendees will understand the establishment and basics of GLP principles. The responsibility of each member of the lab team with respect to testing, documentation and verification.
This webinar provides all the necessary information concerning the ICH GCP-the only global GCP. ICH GCP is not only the only global GCP it is also the most current GCP. If you are involved with clinical trials the ICH GCP is a must for you.
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
The FDA, GAMP and others provide guidance in the methodology and documentation to achieve this. Consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V. This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
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.
This webinar will provide a detailed discussion of understanding the definition of a combination product, the categories of combination products, how combination products are reviewed, how to assemble a request for designation (RFD) and how to work with FDA when submitting applications for combination products. To do this it will reference the extensive information provided by FDA's Office of Combination Products.
The FDA's "Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations", Part D (Evaluation Activities), #2 (Conduct Internal Audits) establishes as an FDA recommendation that "A quality systems approach calls for audits to be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and specifications."
Today's manufacturers face enormous challenges managing their quality and compliance initiatives. Market trends point to even greater scrutiny of these efforts as pressure mounts from both consumers and regulatory agencies for manufacturers across a broad range of industries to deliver better, safer products and services. To meet these important regulatory challenges, it is imperative that manufacturers have a quality management system to manage processes and provide timely access to relevant data, effectively and efficiently.
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.
Information provided will allow an attendee to determine if their company is distributing combinations products, to understand the various forms of combination products, as defined by the FDA, to understand the Part 4 regulations, and to understand the manufacturer’s options with respect to complying with the Part 4 regulations.
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.
No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters.
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".
This training will introduce the chronology of the HACCP program in the US food industry, covering critical historical events and program developments. The 7 HACCP principles and elements thereof will be discussed to give trainees a comprehensive overview of HACCP. In order to round out the understanding of this critical food safety initiative, the interaction of prerequisite programs will be discussed as well.
This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures. The webinar details the common problems and how to avoid them.
The objective of this web seminar is to provide a comprehensive overview of the approach used to establish an effective and compliant stability program for small molecule pharmaceuticals. Discussion will include a thorough review of cGMP regulations and ICH Stability guidelines, development stability testing protocol supporting global markets, and strategies to minimize redundant testing for resource saving.
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.
This topic addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation.
This webinar covers FDA's 4 programs to facilitate and expedite development and review of new drugs/biologics to address unmet medical needs in the treatment of a serious or life-threatening condition. The 4 FDA programs are Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation and Accelerated Approval.
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings.
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.
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
This webinar details both regulations and provides details for implementing computerized systems. Learn exactly what is needed to be compliant for all three primary compliance areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11 and the new European equivalent Annex 11. It gets you on the right track for using electronic records and signatures to greatly increase productivity.
FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.
Risk Assessment is a fundamental and intuitive activity that is not new to manufacturing professionals.
This webinar presents an overview of the entire FDA Drug Approval Process. The webinar addresses FDA requirements from discovery to USA marketplace. The webinar begins by developing a molecule, testing it, going through the IND process, human clinical testing and then the NDA process.
This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, efficacy and/or data integrity. Key components of documentation and record management system will be introduced. Regulatory requirements will also be discussed as the basis of documentation standards. It will also cover different types of records and how it would affect quality systems.
The webinar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. 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.
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.
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?
This webinar is intended for executives and managers, and explains the business fundamentals of regulatory compliance. It explains what does and does not need to be validated. It describes exactly what is required for compliance with 21 CFR Part 11.
How to Develop World Class Quality Systems that will comply with the new audits such as BRC, SQF, Retail and Restaurant Brands.
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.
FDA regulates the nonclinical safety testing of Drugs, Biologics and Medical Devices under a regulation called The Good Laboratory Practices (GLP)regulation. This webinar will address the reasoning for and the requirements of the GLP regulation. Every section of the GLP (Subparts A - Subpart K) will be addressed. FDA's "umbrella" approach to the GLP will also be discuss and FDA interpretations of the GLP reviewed.
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
This webinar will discuss the 9 required elements of a Design Control System. It will consider different methods of implementation, and expectations of the U.S. FDA, proven by documentation.
FDA recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product.
Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association between the product and a safety signal is present.
Participants will gain a solid understanding of how the OC curve is built, how to use it, and how to identify some of the most important points on the curve, including the AQL and RQL points.
This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project.
This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a "living document".
The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so.
A comprehensive review of an ideal chemical control program will be presented.
Next, detailed descriptions are given for how to calculate confidence/reliability for data that is either pass/fail (i.e., "attribute" data), normally-distributed measurement data, non-normally distributed measurement data that can be transformed into normality, or non-normally distributed measurement data that cannot be transformed into normality.
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.
This webinar details the regulation and how it applies to computerized systems
Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually.
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.
We will cover several topics of value to food manufacturing sanitation team members. We will begin with a conceptual understanding of cleaning vs. sanitation.
This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented.
The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation. This event is applicable to regulated companies and software vendors.
This webinar will provide an overview and guidance to firms that are either going through or preparing to go through clinical trials and working with clinical investigators.
The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".
There is a continuing pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems.
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
Establishing HACCP, Preventative and Corrective Maintenance, GMPs and Pest Control programs will reduce foreign material contamination incidences and ensure safe, wholesome, unadulterated products for consumers.
Some pharmaceutical companies do not have the experience in the regulatory area which includes knowledge of the process, needs, and results necessary for a company to be productive at the regulatory agency. Just as a couple dances together, the pharmaceutical company "dances" with the regulatory agency. Neither of the partners wants to step on the feet of the other.
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".
CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.
When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?