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.
Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs - which is often redundant, repetitive, and chained together in a cumbersome way?
IFRS requires that you make irrevocable choices in assigning values to financial instruments. So if your company reports financial instruments on the Balance Sheet, you need to be up-to-speed on these new rules which have the potential to affect the company for years to come. This presentation will provide you with a point-by-point summary of the items contained in the IFRS standard.
Power Pivot takes Pivot Tables and data analysis to the next level. If you're a fan of Pivot Tables, you'll love Power Pivot. It lets you quickly and easily create Pivot Tables from multiple data sets (no VLOOKUP required) and enables you to analyze your data in ways that you've never been able to do before thanks to some new Power Pivot functions (known as DAX functions). Power Pivot lets you work with datasets that span millions of rows.
Payments made by businesses to other businesses for services and rentals must be reported on a Form 1099. Since the IRS uses 1099 information to estimate a company's/persons income tax liability the IRS is serious about 1099 compliance. Congress has increased penalties for failure to timely file accurate information documents (1099s) to $250 per form per year. Form W-9 contains the information necessary to determine who to send a Form 1099, the name of the individual/company, and the appropriate SSN, EIN, or TIN. Good W-9 procedures enhance the accuracy of the Forms 1099 prepared.
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.
Compositional data arise naturally in several branches of science, including geology. In geochemistry, for example, these constrained data seem to occur typically, when one normalizes raw data or when one obtains the output from a constrained estimation procedure, such as percentages, ppm, ppb, molar concentrations, etc. Compositional data have proved difficult to handle statistically because of the awkward constraint that the components of each vector must sum to unity. The special property of compositional data (the fact that the determinations on each specimen sum to a constant) means that the variables involved in the study occur in constrained space defined by the simplex, a restricted part of real space.
To gain insight with regard to future expectations of the FDA with regard to quality metrics. Since the publication of the draft guidance there have been independent studies performed on behalf of the FDA.
The objective of any report is to provide important information to management in the area reviewed. It represents the end result of weeks of reviews, analyses, interviews and discussions. The quality of that report will have an impact on how well the report is understood and accepted. The best information and recommendations may not be acted upon if the report is poorly written. Poor quality reports can result in management:
This webinar provides a brief history of the Bayh-Dole Act, where it is managed within the federal government, the invention reporting requirements of grantees to the federal government, an example of how a university coordinates invention reporting requirements to complete timely reporting requirements of the Act. In addition to those provisions that apply to all organizations, non-profit organizations are subject to three obligations that those that seek intellectual property rights via license contracts need to be aware of.
This program is going to be presented to give the attendees a better or broader perspective of how to use this program from a more comprehensive understanding based upon how this system has been proven to be very successful in gaining FDA approval when the field inspectors have come in to do their job to ensure this facility is operating in a way that is very reliable and consistent in dong what is needed to minimize patient risk.
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
This webinar will uncover the scope and impact of intellectual property theft. We will define the various terms used in the field of intellectual property protection and management.Case studies will be used to illustrate the risks and hazards of intellectual property theft. Strategies, tactic and techniques for preventing IP theft will be discussed.What actions should you take if your IP is stolen or miss-used will be outlined.
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.
This session describes what a leading indicator is, how to use it, and how to measure it. We ask ourselves "I know what went wrong because I investigated it and tracked it", but how do I know "what went right." That is a question we all ask ourselves and our clients (the bosses) especially want to know because they have to justify the money spent and the resources allocated to the safety and environmental activities. When we have good months or even good years (the statistics on incidents are low) how do we know why. If the safety statistics or environmental incidents graph shows peaks and dips over the last several years - WHY? If the graph shows a high, then a gradual lowering with a continuous low over several years - WHY?
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.
Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect.
Third party agreements cover everything from cleaning to the provision and operation of strategic information technology systems. From the simplest of services to the most complex, such agreements can bring significant benefits including economies, more effective services than could be delivered in house and expert knowledge and skills. However, this comes at a price: strategic risks and new uncertainties can hide within such agreements.
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".
Internal fraud is has been around long before Sarbanes-Oxley and will be with us when we retire. According to the Association of Certified Fraud Examiners(ACFE), it is estimated that 5% of all revenue is lost to occupational fraud every year. Fraud is not completely preventable but there are steps you can take to systemically prevent and detect fraud on an ongoing basis. This webinar will discuss several key areas to investigate, how to uncover fraud, and put a plan in place to prevent it going forward.
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
The United Nations Convention Against Corruption was formed as a committee in 2003 to help combat what was being seen as an epidemic against free trade. Organizations working in the international arena now face greater regulatory challenges to continue practicing, to educate their employees, and to monitor for violations. The legal loophole is spreading and the FCPA has recently held financial institutions liable for not reporting clients who fail to comply with FCPA requirements.
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.
This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many common types of experiments and their applications are presented. These include experiments appropriate for screening, optimization, mixtures/formulations, etc. Several important techniques in experimental design (such as replication, blocking, and randomization) are introduced. A Case Study involving optimizing a manufacturing process with multiple responses is presented.
No crystal ball or Tarot cards will be used in the making of predictions covered in this program. This webinar will provide results obtained by surveying experts in a variety of fields and disciplines. Each potential regulatory change will be weighed for probability and size of its effect. Compliance areas that are targeted for drastic changes include:
Come celebrate the union of the PFMEA and the CP! See how the Dynamic Control Plan (DCP) combines both tools into ONE enabling the savings of hundreds of hours of Engineering time, reducing the risk of documentation errors, and, actually improving QMS effectiveness while reducing repetitious work. This session will show you how you can benefit from the DCP!
Pivot Tables are one of the most powerful tools in Excel's data analysis armoury. With just a few clicks of the mouse (and no complicated formulas) you can quickly and easily build reports and charts that summarise and analyse large amounts of raw data and help you to spot trends and get answers to the important questions on which you base your key business decisions.
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.
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
The Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025:2005 for laboratory accreditation in food/water microbiology. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses. Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005.
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.
At a loss at to how to approach the required documentation of SOX controls? How can you keep your bosses and the DEC happy along with the auditor? This presentation will show you how simple it can be to deliver SOX documentation which auditors and executives are pleased to sign.
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.
If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
There is a saying,a picture is worth a thousand words.In Excel that means finding ways to represent numerical data pictorially so that your audience can quickly and easily understand it. It's often easier to look at a chart or graph that interprets trends in a set of data, than to just look at a set of figures.
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.
Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic.
We will introduce you to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. Even over new areas with limited or nonexistent geological information we are able to help you concentrate your exploration efforts to keep your budget in the black.
The objective is to better understand the breadth of retail payments compliance issues and how to create a framework for reviewing both internal and third-party responsibilities for a successful audit. The primary objectives this session are to evaluate the effectiveness of the internal controls and risk management processes implemented by the financial institution and/or the technology service provider.
Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified. However, not all SPC programs deliver to their highest capability as there are many elements to get right to achieve maximum utility.
This topic discusses in detail, the process of how to develop high performance expectations through setting SMART goals and objectives, getting the support you need in order to achieve the goals, and how to measure if the goals are working for you and the company you work for. It is a step-by-step process from defining the objectives, setting up the guiding principles, setting the high performance objectives (HPE), establishing the key accountabilities, working up a development plan, defining the employee and supervisor goals, and setting up the "go forward" plan for the actual goal setting processes. We also develop a "Goal Matrix" where people can track their progress on a month-to-month basis.
ANSI/ASQ Z1.9 is the variables (real number) data counterpart of ANSI/ASQ Z1.4 (formerly MIL-STD 105) for sampling by attributes or good/bad data. It begins with the lot size N and the sampling level to define a sample size n (n is far smaller than N) and acceptance criteria for the sample's average and standard deviation. Procedures also are available that use the sample range and, more importantly, a known rather than a sample standard deviation as might be obtained from a stable process. The latter allows the use of smaller samples than when only sample standard deviations are available.
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.
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S Custom's ACE software program require more information from the foreign source(s).FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise,you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software.
A properly completed Form W-9 will ensure accuracy on Forms 1099. We will cover a line by line review of Form W-9's, who should receive a W-9, and hints on reviewing W-9s for accuracy. These steps will lead to the accuracy of information on the Form 1099.
Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently. It's all the more important as data collection has become more automated and you're getting swamped with tons of data.
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).
Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring (EM) Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monitoring (Pre-qualification through post-qualification EM) and what each type stands for. List the basic content of a well-designed, effective and compliant EM Program. Explain the relationship between an EM Excursion Program and CAPA
Many laboratories struggle with developing and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs. Once accreditation has been achieved many laboratories have difficulty maintaining the QMS as evidenced by the number of non-conformances cited during the subsequent biannual audits.
If you are an accounting professional you need to become familiar with exactly what these new standards consist of,and what these changes mean for companies. This presentation will help you make sure your company remains compliant with SOX. You will become acquainted with the latest information regarding IFRS and will review how to design and implement controls for IFRS processes.
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.
Every project undertaken is not a guaranteed success; there are many things that can and do go wrong. Overly optimistic budgets or underfunded projects can result in shortcuts or unrealistic pressures on those working on the project. Staff or resources lacking the skills to work on the project see the assignment as a fast track to promotion and may not be willing to admit they can not handle the project, projects escalated to be done quickly may result in shoddy workmanship, resources pulling on time constraints can stretch employees to thin, opposition may even exist that is looking to have the project fail - yes sabotage is more common than many will admit to.
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.
The procedures provided in this session should not be construed as requirements for control implementation. The selection of controls and control implementation should be guided by the risk profile of the institution. We will discuss procedures that provide additional validation verifying the effectiveness of a financial institution's internal control processes over ACH processing, EFT/POS network processing, check item processing, electronic banking-related retail payments processing, and bankcard processing, clearance, and settlement.
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.
In 2004, the Committee of Sponsoring Organizations of the Tread way Commission (COSO), issued a principle-based guidance on designing and implementing an effective enterprise-wide approach to risk management. This guidance defines essential components - such as risk appetite, risk tolerance and portfolio view, provides guidance using common principles, and provides counseling and strategy for an effective program.
This session shows practitioners how to develop and create a Paynter Chart for predictive warranty management. Attendees will see how to actively utilize representative return data, observe the construction of a sample Paynter and then observe the results of the predictive analysis.
If you think that Excel is all about working with numbers then think again. More and more people are turning to Excel to help them to manage list-based and tabular data.In many cases they receive, download or import data from elsewhere and before that data can be used within their business and treated as a credible source of information, it needs be seriously checked and cleaned duplicate entries, non printing characters, extra spaces and capitalisation inconsistencies are all too often present in downloaded and imported data. In this session, you'll learn how to deal with and fix all these issues.
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).
Any company that submits IRS Forms 1099 to the IRS can possibly benefit from using the IRS Taxpayer Identification Number (TIN) Matching program. The program is a free service included in IRS e-services. Any authorized person can access e-services and submit payees for the matching process. The IRS will not tell you the correct TIN but they will let you know that the TIN and Name combination you submitted is incorrect.
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.
Product Reliability requirements must be satisfied like all other performance requirements prior to product launch. However, since reliability is a function of time, the methods for verifying that reliability performance has been verified differ than for most other performance characteristics.
All manufacturing processes include random variation in part dimensions, which is why specifications include a tolerance width (lower and upper specification limits) between which the product is acceptable and will interchange with other parts during assembly. The analogy of a gun target can be used to teach this concept, and the handouts include a Visual Basic program that simulates gun targets side by side with histograms and control charts. Accuracy means that the gun is aimed at the bulls-eye (nominal, halfway between the specification limits) while variation reflects the spread in the shots. A rifle can represent a capable process, while a musket illustrates a non-capable process.
A review of basic AAA analysis. Will cover the 3 basic types of agreements: Agreement with oneself, Agreement to a peer, Agreement to the standard. Both the "Statistical AAA" and the Kappa value will be reviewed. Confidence levels for the result bands will also be reviewed. Incorporation of AAA into the Control Plan and frequency of "calibration" will be reviewed.
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).
If you're like millions of other business professionals, you probably use Microsoft Outlook every day to manage your email, calendar and to do's. It's available for Windows, Mac, mobile and there's even a web version. So there's no excuse not to be organised. Or so the theory goes. The reality is email overload, missed deadlines and calendars so full you have no room to breathe
Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales.Use our proven model to quickly assess the financial condition and results of operations of any business using trend and ratio analysis.Join C-suites and business analysts from around the country and empower your team to maximize the benefit from your crystal clear understanding of the numbers.
IFRS #6 requires that companies that have assets used for exploration and evaluation of mineral resources must issue IFRS compliant financial statements. As an accounting professional, you should be familiar with exactly what these new standards consist of, and what they mean for companies in the oil, gas and mining industries. This presentation will help you become acquainted with the latest information regarding IFRS for companies in the resource sector.
The purpose of a designed experiment is to distinguish between random chance (luck) and genuine effects of an experimental treatment versus a control, or genuine differences between choices of materials, machines,methods, or other factors from the familiar cause and effect diagram. That is, if an improvement team identifies the choice of material,e.g. from one of three suppliers,as a possible factor that affects the outgoing quality,DOE can prove beyond a quantifiable reasonable doubt that it does. This reasonable doubt is known as the significance level in hypothesis testing.
This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. The difference between pre release and post release change control will be explained. Methods to control the transfer and approval of changes between the company and its suppliers or contract manufacturers will be explained. Change control forms will be provided and described in detail.
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.
Identifying, mitigating, and stopping fraud is the key to a successful program. Time is of the essence in identifying and reporting this fraud to recover any losses. You should be armed with the tools necessary to properly audit your current process to make sure the potential for fraud is limited.
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.
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.
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.
Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005. Unfortunately, the terms are often incorrectly used interchangeably, resulting in confusion and the application of inappropriate or inadequate analytical evaluations.
New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) beginning July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents is being written, which will replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU.
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.
Pre-Control is easier than SPC! With no control limits to calculate and go/no go colored zones, this control tool can rapidly help to reduce process variation. Participants will observe a modeled session that both develops and runs a Pre-Control chart.
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.
Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job.
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools.
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.
Financial institutions have long been the payments engines for their customers. However, with heightened competition and the advent of new non-bank entries into the marketplace, financial institutions have been playing more defense than offense. It is now time to go from playing 'not to lose' to using the implied trust and the customer experience to reverse the trend, get back lost customers,and retain existing ones.
Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many life science companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process improvements in a timely manner.
Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness.
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.
Join us for 90 minutes to learn how to put the powerful sensitivity tools of Microsoft Excel to work in your models. Learn the top 20 best practices of solid model design, development and delivery. Seasoned financial analyst, Miles Hutchinson, will show you how to unlock the power of scroll bars and spinners, goal seek, one and two-input data tables and scenario manager in your models. He will provide you with samples of the tools demonstrated during the webinar along with complete instructions for creating and using each of these tools.
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.
Statistical textbooks, manuals, and even most software rely on the assumption that processes conform to the normal or bell curve distribution. When the real world process does not cooperate with this assumption,
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".
At the completion of this course you will have the tools necessary to evaluate the W9 and prepare a Form 1099-MISC with all the blocks properly completed. This course will cover not only these common mistakes but make suggestions regarding the contents of each Block on the Form 1099-MISC.
If you are constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.
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.
Manufacturing professionals recognize that inventory ties up cash, provides a hiding place for defects, and also increases cycle time according to Little's Law (inventory = cycle time multiplied by throughput). Alternatively, longer cycle times generate more inventory and also increase the lead time for customer orders. A short cycle time may make the difference between manufacturing to order and manufacturing to meet uncertain sales forecasts.
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.