Compliance4all is the ultimate continuing professional education provider offers you regulatory and compliance trainings and customized consulting from the industry's leading experts.
We conduct online webinars and 2 days in-person seminars to participants in the US and other parts of the globe.
The area's on our Speakers speacilised in:
Food & Beverages
Banking & Insurance
Auditing/ Accounting & Tax
General counsel/ Accountant
Traffic flow management
Electronics & Semiconductor
Science and Technology
Purchasing & Vendor Relation
We conduct online webinars and 2 days in-person seminars to participants in the US and other parts of the globe.
The area's on our Speakers speacilised in:
Food & Beverages
Banking & Insurance
Auditing/ Accounting & Tax
General counsel/ Accountant
Traffic flow management
Electronics & Semiconductor
Science and Technology
Purchasing & Vendor Relation
Compliance4all is based in Fremont, CA, USA
In addition, as an online training solutions provider that brings the world's best known names for regulatory and compliance trainings through webinars that fill your knowledge gap; Compliance4All comes with other major benefits:
The webinars are simple and focused on your particular area of interest;
We have a panel of Experts that has vast and deep knowledge and expertise of the subject matter;
Our webinars foster interaction with Experts. This is a great opportunity to have all your doubts cleared;
Participants can participate from any part of the world.
The webinars are simple and focused on your particular area of interest;
We have a panel of Experts that has vast and deep knowledge and expertise of the subject matter;
Our webinars foster interaction with Experts. This is a great opportunity to have all your doubts cleared;
Participants can participate from any part of the world.
learn at home
DVD video training
e-book digital book
train the trainer
Accounting and Tax Procedures to Maximize your Deductions and Minimize Problems with The IRS : Overview Small business owners and startup companies often lack the resources to hire someone to properly set up their accounting system and their policies and procedures. They often don't know what they can and cannot deduct and, even if they do, they are unsure of the proper documentation requirements. In this webinar, we will give you a solid foundation to build your accounting system on so that you can maximize your deductions and minimize any problems with the Internal Revenue Service. This webinar has been developed by a CPA who has been licensed for over 30 years more...
Air Route Traffic Control Center ARTCC Operations : Overview: This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Air Route Traffic Control Center (ARTCC). The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace. The next topic addresses the airspace structure within the ARTCC, including the more...
Air Route Traffic Control Center ARTCC Operations - Webinar By the Speaker Stephen Alvania : Overview This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Air Route Traffic Control Center (ARTCC). The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace.
Airport Traffic Control Tower ATCT - Online Webinar By Stephen Alvania : Overview This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Airport Traffic Control Tower (ATCT). The initial subject focuses on the primary control positions located in the tower. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage aircraft operating on the Airport Movement Area (more...
Alternate Service Delivery - Canadas Approach to Industry Provided In Service Support for Military Aircraft Fleets : Overview Alternate Service Delivery as provided by industry in Canada offers various approaches to the provision of in service support for military aircraft ranging from total support to limited support for 3rd line requirements. The background to Canadaa s approach that has been evolving for the past two decades is instructive as it started with one fleet and then was extended to others as it proved its worth as an efficient and effective method of supporting various types of aircraft. The more...
Aware of the Similarities and Differences in the files : In this Interactive presentation John E Lincoln is going to discuss about Latest U. S FDA and European Union Regulatory Requirements on Design History File, Technical File / Design Dossier.
Beef Tenderness - Webinar By Compliance4all : Overview The successful incorporation of beef in the food industry involves providing consumers with consistently tender beef. To ensure that this challenge is attained, the food industry needs to be familiar with the factors that contribute to beef tenderness and how this important trait can be maximized. This status is attained through the antemortem, postmortem, and food preparation techniques that are available. This webinar will address available technology to enhance tenderness and how these treatments may be incorporated. As the food processing and foodservice industry have grown and consumers have become more sophisticated and demanding, tenderness enhancement has become more...
Best Practices of Environmental Cleaning - 60 Minutes online webinar by Compliance4all : Overview Companies must provide effective Food Safety training for all employees including managers, supervisors, sanitation employees and production employees in order to produce a safe quality food product. Proper Environmental Cleaning is just as important as the cleaning of the "inside" of food processing equipment. The exterior of equipment, floors, walls, ceilings, doorways and drains can be a major source of microbial contamination if not properly controlled. This presentation will review sources of more...
Business of Defence Procurement in Canada- A Market Over : Overview The Defence Procurement Strategy announced in February 2014 is designed to address many of the problems that have plagued defence procurement policy for many years. It includes changes in responsibility, changes in the Industrial Regional Benefits Policy and changes in the way in which proposals are prepared and evaluated. This webinar will explain the DPS in detail and will brief participants on the major defence procurements planned over the next more...
Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials : Overview: A comprehensive review of an ideal chemical control program will be presented. The guidelines presented will enable your company to implement programs that are cost effective and meet or exceed the expectations of major QSR, and GFSI audit criteria. This presentation will provide not only a provide schematic for management and control of chemicals, but an interactive and customizable course for personnel to meet program training requirements.
Compliance and Food Safety Risks How to Manage Them : Overview When we are making a Food Safety Plan (specifically a HACCP plan), implementing a Food Safety Management System or solving audit non-compliances we face a lot of risk assessment situations that challenge us to assess consequences, prioritize actions and determine future prevention efforts. Risk assessments in food safety are scenario specific. For example, we can investigate the severity of Escherichia coli as a hazard and the probability of its occurrence in more...
Detecting Frauds in Purchasing and Payables - Webinar By Compliance4all : Overview Fraud and abuse losses continue to significantly impact as many as 70% of businesses, governments and non-profits annually. Purchases (from large projects to minor daily expenses) can represent as much as 60% of an organization's spending and provides those looking to steal and defraud an attractive target. Awareness of the most common fraud approaches in the procurement and accounts payable areas and how to spot them is a critical first step in reducing the potential for fraud in any organization.
Drug Master Files Understanding and Meeting your Regulatory and Processing Responsibilities : Overview: This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of more...
Evaluating Your Compliance Training - Are You Providing Enough : Overview Financial institutions are required to be compliant with laws and regulations. Such compliance needs to be well documented and consistent to ensure financial institutions avoid violations and implications. However, financial institutions often rely on their training programs to provide knowledge and education to their personnel. This training needs to be sufficient and thorough enough to provide the necessary information for them to properly perform their roles and responsibilities while remaining compliant. Why should you attend: Although financial institutions have been managing their training program per the regulation requirements, determining if more...
FDA Regulation of In Vitro Diagnostics : Overview: In vitro diagnostic devices, or IVDs, are assays designed to test body fluids for the presence of any substance of interest to researchers, clinicians, and healthcare providers. IVDs can be used to detect hormones or antibodies, viruses or expressed cancer genes, bacteria or bacterial resistance to antibiotics, and beyond. The Food and Drug Administration (FDA) has created a flexible, yet sometimes confusing, approach to IVD regulation. In addition, FDA regulation and more...
Fine Tuning your GRC Program to the Federal Sentencing Guidelines FSGO : Overview Ethics officers have one of the most challenging compliance risk jobs in the country. How does one reasonably ensure that ethical behavior is practiced by all of the employees of the firm given todaya s mobile and geographically diverse business models? The topic, "Fine tuning your GRC program to the Federal Sentencing Guidelines" helps ethics officer fine tune their programs with the help of Behavioral Risk Systems. Almost all regulation and compliance risk more...
Foodservice Sanitation - Webinar By Compliance4allcom : Why should you Attend: Foodservice personnel should attend this event because more knowledge of sanitation is essential to ensure a safe food supply for consumers. Educational information about how sanitary conditions for foodservice establishments can be improved will enhance their reputation, protect against foodborne illness, and increase sales and net profits. Morale of foodservice employees through recognition of the importance of additional training can be accomplished, which will improve employee performance and customer satisfaction. Areas Covered in the more...
Foreign Bodies in Foods - Effective Techniques for Prevention Control and Detection : Overview: Foreign bodies are the most obvious evidence of a contaminated product, its presence in foods is among the biggest source of complaint and prosecution in the food industry. To the food processor or manufacturer, foreign body contamination can be costly and may include the cost of a product recall, legal expenses and ultimately, the costs of lost reputation and consumer confidence. Therefore, it is essential that the food supply and allied industries act in line with the current Food Safety Modernization Act (FSMA) that mandates all processing facilities more...
Forms W-4 W-2 Update and Best Practices for 2014 - Webinar By Compliance4allcom : Learn the latest updates on Form W-2 and Form W-2 wage and withholding reporting. This webinar will prepare your staff for the upcoming filing year, improve your employee reporting set-up and maintenance practices, and reduce your risk of complaints & penalties from the IRS. Experienced CPA and businessman Miles Hutchinson will review the current law and regulations regarding the filing of Forms W-2 and W-4 and will provide practical guidance in these areas that have become the subject of increasing IRS scrutiny.
Guidelines for New FDA Transfer of Analytical Methods - 2017 : Overview: 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'.
Hot Issues in Determining Multi-State Sales Tax Nexus : Overview Gain valuable insight into the complex issues of interstate sales and the obligations of out-of-state (foreign) sellers to collect the destination statea s taxes. Get up-to-date information about the retailing giants and their fights with the various states. Take a ring-side seat with an expert who will share the anticipated outcomes. Why should you attend: Will I owe taxes in more than one state for the same sale? Must I charge tax on my internet sales? Why is my drop shipper charging me tax? Why did I receive a NEXUS Questionnaire and what if I dona t respond to it? Learn the nexus triggers more...
How to Comply with both in the Same Organization : Overview: This ISO 13485: 2016 webinar is a standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices.
How to Validate for Regulated Computer Systems : Overview: You'll learn about the various computer system validation deliverables and how to document them through the entire process. You will learn about what must be done to ensure the system remains in a validated state.
ISO Standard for Business Continuity ISO 22301 - Webinar By Compliance4all : Overview Learn how to create and ISO 22301program to plan, establish, implement, operate, monitor, review, maintain and continually improve a documented management system to protect against, reduce the likelihood of occurrence, prepare for, respond to, and recover from disruptive incidents when they arise. ISO 22301: 2012 specifies requirements to plan, establish, implement, operate, monitor, review, maintain and continually improve a documented management system to protect against, reduce the likelihood of occurrence, prepare for, respond to, and recover from disruptive incidents when they arise. The more...
IT Auditing - Principles and Practices 2nd Edition : Overview: There exists apparent financial auditor (FA) and IT auditor responsibility overlaps. One reason this interrelationship exists is because, when planning audits, the FA and IT auditor evaluate manual as well as automated processing. However, there is a distinguishing feature that is obvious. As most of the professional audit community is aware, an FA fundamentally focuses on financial transactions, whereas, the IT auditor places emphasis on system processing. In addition, the FA's assessment is mandated by assertions presented in financial statements. Though concerned about the same claims, the IT auditor has other reasons for performing an IT audit. Therefore, more...
Mastering the Power of Sensitivity Tools in Financial Modeling : Overview 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. Why should you more...
Meeting the requirements of Federal Financial Institutions Examination Councils FFIEC : Overview Learn to properly use the Federal Financial Institutions Examination Council FFIEC as a guideline to prepare for an impact to the business for any organization. We will cover how to identify, analyze and document the events and environmental surroundings that can adversely affect the organization. You will learn how to both prepare and review the continuity planning program in accordance with FFIEC guidelines. Areas such as IT Outsourcing and other risks will be covered. It is critical to assess the IT and Information Security risks and the effectiveness of the more...
NDAs and INDs for Orally-Administered Drug Products : Overview: This webinar will be helpful to applicants conducting BA/ BE studies during the IND period, also FDA guidance recommendations on how to meet the BA and BE requirements in 21 CFR 320 as they apply to oral dosage forms.
Planning for Resilience - Best Practices for Developing Reliable Disaster Recovery Plans : In order for a company to be truly prepared all three plans have to flow into each other effortlessly. This presentation will cover the importance of getting management buy in. Of combining the plans in such a way that there is a clear incident management structure. Crisis planning covers situations such as disgruntled employees, anthrax scares, hostage situations etc. Although very serious, the event does not affect the whole company and does not affect the structure or data. An Emergency Plan covers situations such as Ice alerts, hurricanes, earthquakes as well as terrorist more...
Regulatory Requirements for Medical Device Calibration Programs : Overview: Calibration is an essential component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement. The presentation states with the regulatory requirements in the FDA's QSR, ISO 13485, and ISO 9001. After analysis of these requirements, more...
Risk of Transmission of Carbapenem-Resistant Enterobacteriaceae CRE and Related Superbugs during Gastrointestinal GI Endoscopy : This lecture focuses on the recent emergence of the superbug carbapenem-resistant Enterobacteriaceae (CRE). The details of a recent outbreak of CRE following GI endoscopy performed at a hospital in Illinois in 2013, with associated morbidity and mortality, is discussed. Failure to properly clean and disinfect GI endoscopes and their accessories has been directly linked to superbug transmissions, increasing a GI endoscopy suite's legal exposure. The history of transmission of infectious pathogens before and since CRE's emergence in 2001 more...
Sanitation Chemical Testing - Best Practices : Overview Companies must provide effective Food Safety training for all employees including managers, supervisors, sanitation employees and production employees in order to produce a safe quality food product. The objective of this presentation is to equip the participants with the basic skills and knowledge to properly perform a titration drop count test on food plant chemical cleaners and sanitizers. The participants will also be presented with a basic review of the most common single parameter titration test kits used on chemical detergents and sanitizers. Examples of "Audit more...
The National Shipbuilding Procurement Strategy- Changing the playing field for shipbuilding in Canada : Areas Covered in the Session: NSPS Background National Shipbuilding Policy in Canada Navy Requirements Coast Guard Requirements Ship procurement issues in Canada Towards a new policy National Shipbuilding Procurement Strategy- Outcomes NSPS Process NSPS Requirements for shipyards Current status of the program Future of the program Speaker Profile: Anthony Goode After 30 years of more...
TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties - Webinar By Compliance4allcom : Why should you Attend: How do you know your vendor's W-9's are correct? What are the consequences of filing incorrect name and ID numbers on their 1099's? In just 90 minutes, you can begin to develop a solid plan to move your company toward near absolute regulatory compliance, efficiency improvements, standardized processes, & adequate documentation to ensure your 1099's contain accurate information that will agree with the IRS's records. You will all but eliminate your B-Notices from the IRS! Areas more...
Traffic Flow Management TFM Operations-End to End Flight Scenario : Overview This webinar, one in a series of ATC topics, addresses the operational environment and functioning of ATC System Command Center (ATCSCC). The topic starts with the communication system design that delivers the single ATCSCC facility with the radar and flight data from the entire National Airspace System (NAS) for real time processing and assessment. There is then a discussion of the various goals, strategies, and techniques the more...
Using Forensic Accountants Effectively in the Legal Process : Overview Although steadily expanding for years before Enron, Worldcom and other major frauds in the early 2000s brought the concept into the public's consciousness, the field of forensic accounting has seen rapid growth since then. This growth has steadily increased the areas where forensic accountants can be utilized far beyond just fraud investigations into almost any area where money or other "numbers" are related to the issues in a case. As with any professional area, the appropriate and effective use of forensic accountants within the legal more...Accounting and tax
1099-MISCBlock By Block Discussion - 2017 : This course will cover not only these common mistakes but make suggestions regarding the contents of each Block on the Form 1099-MISC.
Benefits of your SPC Program for Maximizing the 10 Keys : Overview: Highly effective SPC programs combine technical competencies, such as using an appropriate chart and sample size for the application, with effective management techniques such as enabling operator buy-in and involvement. This article identifies ten keys that unleash the power of SPC.
Calculating and Using Statistical Power 2017 : Overview: This webinar explains the basics, by using a t-test as an example. One of the very many possible formulas is then demonstrated, as well as 2 different software programs and their "Power Curves". Why should you Attend: Whenever a test of statistical significance is conducted with the hope that the result will be non-significant, the results may be unacceptable to a regulatory agency unless the test had an acceptable level of "power". Areas Covered in the Session: Vocabulary and more...
Conference about Consumer E-Payments - Complying with Auditors Standards Part I - Identifying and Understanding the Risks : This training will outline and discuss the growing market of electronic payments. We will talk about risk profiles and the quality of risk management practices as required from internal and external auditors. Emerging payment systems also increase the use of nonbank third parties which will increase risk factors and weak points in the process.
Excel Formulas and Functions in Mastering : Overview: 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.
Excels Data Management Tools in 2016 by Compliance4all : Overview: New regulations are going to dramatically increase banking charges and exporters are going to be impacted more than most. Coming on the heels of the banking crisis of 2008, Basel III is the latest attempt at creating a global set of regulations that assure the ability of banks to sustain credit losses in a financial downturn.
How to Design and Implement Outstanding KPI Performance Dashboards : In just 90 minutes, Miles Hutchinson, experienced CGMA and business adviser, will explain how to get the most from your KPI dashboards and help improve your bottom line!
How to Validate and use Excel Requirements : How to design spreadsheets for compliance , also how to ensure and validate spreadsheet integrity.
Mastering Excel 2013 Pivot Tables : How to use Slicers instead of filters to identify which field elements are displayed
Spreadsheet Validation for FDA 21 CFR Part 11 : This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations.
The Impact of Basel III on Export Finance in 2016 by Compliance4all : Overview: New regulations are going to dramatically increase banking charges and exporters are going to be impacted more than most.
US Exports and Proper Use of EAR99 - 2017 : This course will explain about US Export Filing Requirements and the proper use of EAR 99 , and what documents are required for exporting.
Using the ISP98 Model Forms for Standby Letters of Credit : Overview: Letters of credit are commonly used in business transactions to ensure payment and performance by the parties. Over $600 billion of standby letters of credit are currently outstanding in the U. S. marketplace. The transactions they support can be complex, leading to concern that the letters of credit be properly worded. The majority of these letters of credit are subject, by their terms, to the International Standby Practices ("ISP98"), a body of rules and practices designed for making standby letters of credit dependable instruments for the purposes more...
Webinar on Exporters of Foreign Assets Control Anti-Boycott and Anti-Money Regulations : Overview: U. S. exporters are not only required to understand complex licensing requirements regarding the goods they sell, they must adhere to U. S. sanctions against "enemy" countries (foreign assets control regulations) and refuse to comply with sanctions imposed by other countries (anti-boycott regulations).Fda Compliance
2016 webinar on Healthcare Hazard Control and Safety Management : Overview: Companies must provide effective chemical safety training for all employees including managers, supervisors, operators and temporary workers. The objective of this presentation is to equip the participants with the basic skills and knowledge to assess chemical hazards in their workplace. The participants will also be presented with basic controls for working safely with chemical detergents and sanitizers used in food processing plants.
2016 webinar on How to Ensure You Get the Correct One : The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.
2016 webinar on Polymer Materials Selection for Radiation-Sterilized Products : 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.
Analytical Materials used in Microbiology Laboratories to control the quality : Overview: We will discuss a practical QC approach for in-house prepared and/ or commercially purchased media, test kits and reagents specifically applicable to microbiology laboratories.
Calibration and Qualification in Analytical Laboratories : 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.
Conducting Observational Studies in US Canada and Europe : This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada.
Conference about Predictive Warranty using Paynter Charts : 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.
Conference about 2011 FDA Guideline on Process Validation : 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.
Conference about Best Practices for an Effective Cleaning Validation Procedures : 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.
Conference about Combination Products FDAs Final Rule for GMP Requirements : Overview: 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?
Conference about Effective Techniques for Prevention Control and Detection : Foreign bodies are the most obvious evidence of a contaminated product, its presence in foods is among the biggest source of complaint and prosecution in the food industry. To the food processor or manufacturer, foreign body contamination can be costly and may include the cost of a product recall, legal expenses and ultimately, the costs of lost reputation and consumer confidence.
Conference about Effective Training Practices for FDA Compliance : 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.
Conference about FDA - Legal Writing Skills that Result in Effective Regulatory Submissions : Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.
Conference about FDA Regulations for Environmental MonitoringEM Program : Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring (EM) Program fits into the Regulations.
Conference about Forecasting for Profit The Basics : This webinar will cover the basics of creating a model to forecast variables that are relevant to a business such as product demand or price of an important input. What are the steps to formulating a forecast model? How do you estimate a model? What are the potential pitfalls in formulating and estimating a model? How do you determine which model formulation performs best? How do you test your model? What do you need to do once you have built your model?
Conference about Introduction to FDA Regulation of Combination Products : 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: A product comprised of two or more regulated components (i. e., drug/ device, biologic/ device, drug/ biologic, or drug/ device/ biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity.
Conference about Pest Control in Food Processing and Foodservice : Effective sanitation in the food industry involves the maintenance of clean conditions in the entire food operation including the control of pests such as cockroaches, houseflies, rats, mice, and birds. This status is attained through the prevention of pest entry and eradication of those that infiltrate food establishments.
Conference about Quality by Design The Value of CRF Mapping : The clinical research community continues to struggle with privacy protections and the subsequent limitations on direct access to electronic health records (EHR) for monitors, auditors and even regulatory authorities. Since these EHRs house the original source data supporting regulatory approvals, some level of source document verification is expected.
Conference about Reporting Adverse Event - Regulatory Requirements : Before the celebration of a successful clinical development of a novel therapeutic molecule, the teams face several years of challenges with the drug development process.
Conference about SOPs for Clinical Trials - Regulatory Requirement and Key to Effective Management : Since the year 2000 there has been an increasing trend of registered clinical studies from approximately 4, 000 in 2000 to 160, 000 in 2014. In 2014 Forbes Magazine reported that the FDA had approved 44 drugs the highest in 18 years.
Controlling Human Error in the Manufacturing Floor : This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
Corrective Actions - Current Expectation of ISO 13485 and FDA Auditors : This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity.
Current Challenges in Argentina Brazil and Mexico : Overview: The course will cover topics relating to full product life-cycle management, as well as, address the structure of the regulatory agencies in Latin America.
Device Changes FDA Changes and the 510k Webinar by Compliance4all : 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".
Effective FDA and ISO Management Reviews - 2017 : Learn how to get management's attention to the information being presented and how to make it fit your company culture.
Effective Training Practices for FDA Compliance Webinar by Compliance4all : 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.
Efficient and Effective FDA and ISO Management Reviews : This session will discuss how to make your Management review fit your company and the best ways to get involvement from your senior management
Ensuring Data Integrity and Safety in Clinical Research : Basically electronic records and electronic signatures must be trustworthy, reliable and generally equivalent to paper records and signatures executed on paper.
Environmental Monitoring in Pharmaceutical Clean Rooms : Environmental Monitoring looks at the end results of the Environmental Control program-the microbiological and particulate quality of the clean room.
Equipment and Facility Qualification 2017 : Equipment Qualification, process validation and commissioning have some overlapping areas that have over the years been the source of confusion.
Excel Spreadsheets - Step-By-Step Instructions - 2017 : Overview: 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.
FDA and Regulatory Aspects Training by Compliance4All : 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.
FDA Inspections Dos and Donts : FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.
FDA Regulation of Combination Products : Attend this 60 minutes presentation to gain a fundamental understanding of FDAa s regulation of Combination Products.
FDA Regulation of Combination Products Webinar by Compliance4all : 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
FDA Regulation of Dietary Supplements : 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.
FDA Regulations for Environmental Monitoring Program : Overview: Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring (EM) Program fits into the Regulations.
FDA Regulations for Qualification and Validation Processes - 2017 : This webinar will help attendees understand the instrument qualification and system validation processes.
FDAs enforcement of 21 CFR part 11 compliance : 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. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
GLP Comparison with GMP in Quality System -2017 : GLP is a unique quality system in the sense it is intend for non-routine processes and activities.
Go Beyond ISO 90012015s Requirements Training by Compliance4All : ISO 9001: 2015 requires "actions to address risks and opportunities" with regard to "context of the organization" and "needs and expectations of interested parties." These actions are necessary but not always sufficient to achieve organizational success or even survival because many risks and opportunities are outside the standard's explicit scope.
How FDA Trains its Investigators to Review CAPA - 2017 : Overview: In this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.
How to Conduct a Human Factors - Test following ISO 62366 - 2017 : The post test participant inquiry is critical to validation success. we will describe how to do this.
How to develop and create a Paynter Chart : Overview: 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.
How to develop high performance expectations through setting SMART goals : Overview: 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.
How to Manage an effective FDA Inspection : Overview: 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.
How to Meet FDA QSR and ISO 13485 Requirements - 2017 : Overview: A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures.
How to Respond to an FDA Investigation What happens when the FDA threatens to shut you : Drew Barnholtz has "been there, done that" when it comes to the FDA investigation and Consent Decree process. Learn firsthand of his experience and how his company survived the ordeal.
How to Survive an FDA Inspection : Bioresearch monitoring program or BIMO is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research.
How using such Sampling Plans Leads to Production : Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.
Implementing a Technology Transfer Process - 2017 : Overview: It will cover the concepts associated with transferring the scientific technology needed to manufacture the product, processes to ensure the receiving manufacturing facility is ready for the product and tools and templates to help capture the knowledge.
Integration of ERP and Legacy FDA 2017 : There should be a distinct segregation of duties, as well, meaning all best practices for ensuring that the person responsible for entering data is not the person responsible for reviewing and/ or approving the data.
Introduction to Bioresearch Monitoring : To gain a fundamental understanding of FDA regulation of bioresearch monitoring.
Laboratory Have an Instrument Calibration Program -2017 : What Should be Included in a Calibration Program and the Importance of a data-based Calibration Interval and Limits of accuracy and precision.
Latest Regulations for Tobacco Industry Effective 8-2016 : Overview: The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Why should you Attend: How to Build a Compliance Strategy Minimizing Cost while Maximizing Compliance Knowing the policies and procedures that must be developed and maintained to support the clinical trial system in more...
Lineament Analysis Training by Compliance4All : 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.
Maintaining an Effective CAPA Program in 2016 by Compliance4all : 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.
Market Corrections in Compliance with FDA Webinar by Compliance4all : To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field.
Meeting Annual US FDA cGMP Training Requirements : We will evaluate the chief areas of an FDA CGMP compliance audit to see actual and anticipated changes in emphasis based on this new regulatory climate. We will also discuss proven methods to address such training needs.
Motivation for EHS practitioners : This presentation is designed to maintain the high level of motivation EHS practitioners need in order to stay effective.
New Import Program for FDA 2017 : In this interactive session author will discuss about the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Pest Control in Food Processing Training by Compliance4All : Effective sanitation in the food industry involves the maintenance of clean conditions in the entire food operation including the control of pests such as cockroaches, houseflies, rats, mice, and birds. This status is attained through the prevention of pest entry and eradication of those that infiltrate food establishments.
Principles of Food Extrusion Processing : This webinar describes in detail about the types of extruders, Extrusion process is widely used in food processing.
Product Risk Management Under ISO 14971 Training by Compliance4All : The U. S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time.
Products Used in Early Phase IND Studies : Overview: How it may be integrated with the recommendations of the guidance documents on CMC requirements. Areas Covered in the Session: Discussion of the elements found in the guidance document for Phase 1 material What to do at really early stages What about special IND studies? What about preclinical studies? Who Will Benefit: Regulatory Affairs personnel who coordinate activities for the CMC more...
Protecting the Payments Franchise Training by Compliance4All : 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.
Quality and Compliance for Medical Devices Training by Compliance4All : The role of Quality leaders, general managers, and executives includes "Management Responsibility".
Reduction Using Paynter Charts - 2017 : In this webinar speaker explains how to develop and create a Paynter Chart for predictive warranty management and then process improvement.
Requirements for Compliance Compounding Pharmacies : The first module will cover federal and state regulatory agencies governing compounding pharmacies and handling of hazardous drugs for sterile and nonsterile compounding according to USP 800.
The Investigational Medicinal Product Dossier Webinar by Compliance4all : 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.
The Marriage of the PFMEA and Control Plan Webinar by Compliance4all : 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.
The New FDA-Product Approval Webinar by Compliance4all : The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration. The new commissioner recently announced a new policy for Warning Letters and FDA-483 responses, putting manufacturers under very tight response timelines.
The Role of FDA in Health Care Software Regulations and Development : 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. I
Tools for Human Error Reduction - 2017 : Overview: Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented.
Understanding International ACH - 2017 : Overview: Instructor will cover customer benefits and value proposition regarding International ACH and why it may be preferred over wire transfers.
Understanding of FDAs regulation of Dietary Supplements : Overview: 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).
Warning Letters due to Lack of Comprehension : Overview: 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.
Webinar on Ethics in EHS : There are many forms of ethical behavior, and it is good to know what they are when performing the required tasks of the EHS function. This session discusses those forms, plus outlines situations in which ethics play an important part of decision making, both from a professional and a personal perspective. The session also covers situations that the participants have experienced (without giving away names of people or organizations), and the way they were handled and what the results or consequences were. The session also covers a "value system".
Webinar on Extending Your Drugs Life : This course will describe how a pharmaceutical company can prolong the life of a drug product. The high cost of time, money, and man-hours to develop a new pharmaceutical drug requires that the company hang onto the drug especially during the patent period.
Webinar on The Marriage of the PFMEA and Control Plan A Dynamic Control Plan : Overview: 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!Medical Device
2016 webinar on Monitoring and Enforcing The Quality Agreement : Outsourcing and contracting is continuing to increase in the pharmaceutical industry. Regulations have been in place for some time specifying requirements that ensure that appropriate controls are in place.
Batch Record Review and Product Release - 2017 : This webinar will analyze each necessary elements of the batch record review process.
Biologics Facility Design Pharmaceutical Regulatory Aspects - 2017 : The attendee will learn what is important in facility design from the FDA and regulatory standpoint.
Bullet Proof 510k Latest FDA Changes to the Process : This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). 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
Calibration in the Laboratory in 2016 by Compliance4all : Overview: This web seminar builds on the terminology found in 21CFR160(b)(4) and introduces terminology and concepts not found in the regulation , but necessary for an effective calibration program, such as instrument classifications.
Chemistry 101 for Medical Device Regulatory Webinar by Compliance4all : 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.
Conference about 21 CFR Part 820 - Quality System Regulation : 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.
Conference about A Durable Medical Equipment Revenue Program : Overview: Consider a DME (Durable Medical Equipment) Profit Center for your practice. Your Practice can develop a new revenue stream from your existing patient base by providing braces & pain management solutions right from your own office! Fully compliant with federal and state regulations. You're already creating DME revenue - Why not keep it for your practice?
Conference about Best Practices for Developing Reliable Disaster Recovery Plans : Overview: The best way forward is an efficient disaster recovery solution that helps respond with speed and agility, while empowering businesses to maintain continuous operations during an outage. Such a solution also ensures availability of critical systems, reduces revenue loss, and protects brand reputation. : Emergency Planning, Business Continuity Planning and Crisis Management.
Conference about DMAIC Autism A Sample Size of One : This is an interactive overview of how DMAIC can be utilized in a home environment to improve the quality of life for a child diagnosed as being on the Autism Spectrum. The discussion takes the participants through how DMAIC was successfully used to make viable differences with live metrics and results.
Conference about Drafting a Software VV Documentation Package and Protocol : Overview: The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of the FDA, DAMP, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, to structure, run, and document acceptable software validations.
Conference about International Evidence Requirements for Medical Devices : Stephen Hull, a 20 year veteran of medical device reimbursement will provide first hand insight into the core requirements of key global markets and offer advice on how to best assemble your global evidence strategy. Detailed slide materials will provide the frameworks and pathways for reimbursement across the target markets.
Conference about Key Factors to Write an Effective Standard Operating Procedure : Overview: This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
Conference about Principles of Lean Documents and Lean Configuration : Overview: 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.
Conference about Risk Management for Commissioning and Qualification : Overview: As long as increase in the regulatory requirements and market needs which causes conflicts between inspectional parties and manufacturers along with limited resources for each party, there must be a harmonized baseline between two parties that both must agree on. Upon achieving this harmonization, this will minimize the efforts that will in turn increase the quality of the product.
Conference about Sample Size and Statistical Rationale for Medical Device Packaging Validations : Compliance to ISO 11607, Parts 1 and 2 require that Packaging Validations include the development of a statistical rationale to support the testing conclusions of sterile barrier systems and packaging processes. Learn the basics of a process for developing a validation statistical rationale for packaging sterile barrier systems and processes.
Conference about Sterile Medical Packaging Design - 7 Essentials : Individuals responsible for medical packaging system design and validation are required to provide a safe and effective packaging system that can deliver the enclosed product to the end-user without incurring defect or risk to patient safety.
Conference about The New European Clinical Trial Regulation : The course also covers recent updates on EU-GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.
Conference about Validation Master Planning and Regulatory Expectations : 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.
Construction of the European Drug Master File Training by Compliance4All : Drug master files serve as documentation on the quality of an active ingredient or excipient and are submitted by a manufacturer as part of the licensing or amendment procedure.
Designing Medical Devices for Long Life at Lower Costs : Learn how to design it right the first time for not only long life design but understand that no safety related failures should occur during the long life.
Device Changes FDA Changes and the 510k : 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".
Effective Cleaning Validation Procedures : By attending this webinar attendess will Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product.
Equipment and QMS Software by Verification Process : Overview: 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".
FDA Export Certificates for Medical Devices : Overview: Companies need to stay internationally competitive and this webinar on export certificates provides a key link for entry to markets around the globe. This webinar will explore the export approval and certification process in the U. S. It will include guidance on preparing applications and obtaining FDA's certification that specific products identified for export meet U. S. regulatory requirements. All of this will be valuable in obtaining broader access to global markets. Why should you Attend: In today's global environment, sustaining competitive advantage within the medical device industry more...
FDAs Medical Device Clinical Trials Program in 2016 by Compliance4all : Overview: The topic is device clinical trials. This term refers to the use of medical products on/ in humans, in order to gain useful knowledge about the product.
Fremont 2016 Webinar on Latest FDA Update and Expectations : The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention.
Fremont 2016 Webinar on The Achilles Heel of cGMP Compliance : The last few years have seen an increase in product recalls. For this and other reasons, the U. S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual".
Good Deviation Practice - CAPA Process - 2017 : Overview: 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.
How the New Rules for the Sanitary Transportation : Maintenance and transportation operations must shift gears to assure implementation and reliability of sanitation and temperature controls.
How to Accurate Adverse Event Reporting : Overview: Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects.
How to plan risk based approaches for clinical trials : Overview: You will understand how to identify, evaluate and also how to implement specific risk based techniques for risk management used in clinical trials.
Implementation and Management of GMP Data Integrity 2017 : In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry's responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices.
Investigational Device Exemption Training by Compliance4All : 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.
Is it Method Verification or Validation : Overview: 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.
Join this Webinar to better understand and start taking advantage of Accelerated Aging Techniques : In order to design a test plan that accurately models the time correlated degradation of polymers, it is necessary to have an in-depth knowledge of materials composition and structure, end product use and mis-use, assembly and sterilization process effects.
Lyophilization Technology effective design of the process : Overview: 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.
Managing Your Medical Device Reporting MDR Program for Compliance Success : This webinar will provide valuable assistance and guidance to all medical device companies and user facilities that are required to manage or comply with the provisions of the 21 CFR 803 MDR program.
Medical Device Cybersecurity - Standalone Software to Assure : This webinar will identify the FDA's fundamental premarket and postmarket requirements that involve software.
Medical Device Employee Training - 2017 : Overview: This is especially true for start-up and other small medical device companies, or rapidly growing companies. Specific FDA training requirements will be presented.
Medical Device Engineering Change Control - 2017 : The situation gets complicated when a company has suppliers or contract manufacturers and changes and approvals must pass from one to the other.
Medical Device Hazard Analysis Following ISO 14971 - 2017 : In this webinar we will explain in detail the process of conducting a hazard analysis.
Medical Device Recalls : This seminar will explore key concepts in helping your company stay ahead of the regulatory curve by understanding FDA operations and developing effective mitigations to reduce risk in the recall area.
Medical Device Registration Listing and Inspection Follow-up Activities : This webinar will explore key concepts in helping your company stay ahead of the regulatory curve by understanding FDA operations and developing effective mitigations to reduce risk, wherever your devices are marketed around the globe.
Medical Device Software - Compliance and Quality : This webinar will Explain the fundamentals of Agile method and discuss how an Agile approach, properly followed, can improve development time without sacrificing quality or regulatory compliance, describe various pitfalls related to Agile.
New Cosmetic Product Regulation in World Economies 2017 : In this interactive session speaker will speak on the key regulatory provisions for cosmetic products in the major global economies.
Out-Of-Specification Laboratory Results : This live webinar training will provide a clear process for compliant laboratory OOS investigations, and the discussion will be based on the FDA guidance on handling OOS laboratory results.
Packaging and Labelling for Clinical Products - 2017 : You will learn to translate a protocol into optimal package design.
Preparation for GMP Inspections by Regulatory Agencies - 2017 : This webinar will provide practical tips and advice for ensuring that all inspections.
Process Capability Analysis Webinar by Compliance4all : This method involves first creating a probability plot (Y = %cumulative vs. X = raw data). That step and all subsequent ones can easily and automatically be performed using an Excel spreadsheet.
Review process on Advertising Promotional material compliance - 2017 : Overview: You will hear about the opportunities for input from regulatory agencies at critical stages and on key promotional materials and you will hear strategies for implementing review process and procedures to facilitate high compliance standards.
Root Cause Analysis for CAPA Best Practices - 2017 : We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.
Successful Product Complaint Investigations : Overview: The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored.
Supplier Quality Management - Implement it Now or Pay for it Later : This webinar will provide attendees with the information and tools necessary to develop, implement, and effectively utilize and maintain a program for Supplier Quality Management that will satisfy the FDA's requirements without creating undue burdens for the organization.
Traceability and Recall Through Food Processes Training by Compliance4All : This 60 minute webinar will cover traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls. The session will also cover associated information like identification, classification and protocols.
Validation and Regulatory Approaches in 2016 by Compliance4all : Overview: 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.
Validation Under Good Laboratory Practices 2017 : How to validate an analytical method under the GLP requirements. It is recommended for laboratories that are under, or want to be under, GLP.
Webinar on Analytical Instrument Qualification According The New Revision of USP 1058 : The first version of USP has been released in 2008. Since then it has evolved as the global standard for analytical instrument qualification, despite of some deficiencies of the first version. For example, the industry had difficulties to apply the chapter for systems comprising equipment hardware and computer systems. In addition, there have always been comments about not enough details for the four qualification phases. These deficiencies have been clarified in the new revision with much more details on integrated systems but still some interpretation is required for compliant and efficient implementation. This webinar will discuss all details and give strategies and case studies for easy implementation.
Webinar on Developing an Effective CAPA Program for GMP Operations : Overview: Having an effective CAPA documentation and tracking system are crucial to pharmaceutical operations. This system will allow personnel to identifying the root cause, corrective action taken, and verification stages. This session will discuss important components to create an effective CAPA system, determine different levels of actions to be taken, and training needed to prevent reoccurrence.
Webinar on Establishment of Quality Systems : Overview: 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.
Webinar on Lyophilization Technology : 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.
Webinar on Software Verification and Validation Planning and Documentation : The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", 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.
Webinar on Why You Need to Get Out of the Construction Business : Overview: It doesn't matter whether you are construction buildings or roads; you need to get out of the construction business. No one is suggesting that you stop building things because that's what you do, but that's not your business. The real business you are in is what you do that provides value for clients. If you attempt to compete on construction activities, you will typically end up competing on price, which doesn't work for the contractor.
What are Standards for Medical Device Software -2017 : The effect of new regulatory developments on the medical device manufacture process
Which data and systems are subject to Part 11 : This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity, and explains about the regulation and how it applies to computerized systems.Risk Management
2016 webinar on VISUAL MERCHANDISING The Basics of Excellent Presentation : How Emotional and Sensory merchandising creates a memorable bond between your store and your customers. Using Sensory Merchandising will create amazing memories of your store for customers. People want experiences more than "stuff" and using emotional and sensory techniques will help create those experiences
Analytical Method Validation in FDA process - 2017 : This webinar will discuss method validation requirements through the test method lifecycle: method development, the formal method validation and continued use of the method for routine testing.
B2B Payments in the US and Compliance Issues in 2016 by Compliance4all : Overview: The yearly payment volumes - B2B only - of processors such as CHIPS, Fedwire, SWIFT, and ACH are growing steadily, while checks are declining at a small single-digit rate.
Business Continuity Management Architect and Implement Solution : Learn to properly prepare for an impact to the business for any organization. We will cover how to identify, analyze and document the events and environmental surroundings that can adversely affect the organization.
CAPA Root Cause Analysis in 2016 by Compliance4all : Overview: The course takes one through the rigors of RCA as it applies to CAPA. There are ways of making the journey easier and structuring it so that the right answers are arrived at.
Conducting Safety Reviews for Systems Products Processes facilities and Procedures : This webinar discusses the concept of conducting an inclusive safety reviews in order to evaluate associated risks and mitigations. Safety axioms appropriate to the safety review concept are discussed.
Conference about Auditing Enterprise Risk Management : 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.
Conference about Foreign Corrupt Practices Act - Audits Role : Overview: 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.
Conference about Modeling and Optimizing Process Behavior using Design of Experiments : Overview: 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.
Conference about Risk Assessment and Business Impact Analysis using PMI : Learn to properly manage project to prepare for an impact to the business for any organization. We will cover how to identify, analyze and document the events and environmental surroundings that can adversely affect the organization. You will learn how to both prepare and review the continuity planning program.
Conference about The Bayh-Dole Act and Its Implementing Regulations Rule-Making : Overview: 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.
Designing Full Cyber Security Incident Response Team CSIRT Training Program as well as Table Top and Simulation Testing : Designing a CSIRT Training program, Tests and Simulations are key if an organization wants to be prepared to respond to Breach, Malware and more.
Guidance on Software and Device Changes and the 510k : How to manage software and device changes in an FDA-compliant manner.
How to Develop the Risk Management File - 2017 : To create an effective Risk Management Plan (RMP), you must understand the details behind the mandatory areas.
Introduction to Risk Assessment : The reason for attending would be to gain a perspective and understanding of the proper application of risk assessment.
Laboratory Investigation of Out-of-Specification Results in 2016 by Compliance4all : The discussion will be based on the FDA guidance on handling OOS laboratory results. This live webinar training will provide a clear process for compliant laboratory OOS investigations.
Microsoft Dynamics 365 For Operations Azure : This webinar will explain the challenges and pose practical strategies for the validation of Microsoft Dynamics 365 and Azure.
Preventing Recalls Product Liability in New Product Development : understand the difference between Design Reviews and Product Safety Reviews, nor did anyone probability ever receive formal training in Hazards Analysis and Risk Assessments.
Product Risk Management - ISO 149712007 : This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.
Quality by Design Establishing a Systematic Approach to Pharmaceutical Development : This webinar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles.
Resiliency Individual Community Business : Business Continuity Management (BCM) is a holistic management process that identifies potential impacts that threaten an Organization and provides a framework for building resilience with the capability for an effective response that safeguards the interests of its key stakeholders, reputation, brand and value creating activities.
Sampling Plans for Risk Management Webinar by Compliance4all : 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.
Statistical Analysis of Measurement Uncertainty Metrology - 2017 : All manufacturing and development companies perform testing and/ or inspection that involves measurements of products, components, and/ or raw materials.
Understanding Risk Assessment of Proper Application : Overview: 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.
Webinar on Calibrating the Human Gage Attribute Agreement Analysis : Overview: Defining Attribute Agreement Analysis (AAA): 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.Accounting Tax /Auditing /Banking / insuranceSupply-Chain Finance
Conference about Credit card surcharging What are The Stipulations for Compliance : The worst thing end-user organizations can do is to have an uninformed reaction to surcharging. It's important to first look at the big picture as end-users should also educate suppliers about the economics of card acceptance, pointing out the savings possible and other benefits.
Conference about Managerial Primer for Assuring Information Security : Most entities actively seek maximizing stakeholder return on investments and fostering superior customer relations to sustain creation justification. With information technologies considered indispensable to providing processing efficiency, communication expediency and information reliability for stakeholders; entities need to safeguard adequately information assets because they have measurable value.
Supply-Chain Finance : This session will examine the origins of supply-chain finance, the current state, and the projected future and its impact on importers, exporters, and banks.
Webinar on Building a Lean Culture : Overview: In lean, one of the fundamental differences in culture begins with leadership. Lean leadership is involved in coaching and mentoring their teams to drive operational excellence in an organization. These types of leaders must be present at every level of the organization and must permeate the culture in order to be successful. Some key attributes set lean leadership apart from the norm.
Webinar on Making Supply Chain Decisions Based on Total Cost of Fulfilment : Overview: Is anyone in your organization trying to calculate and minimize total fulfillment costs for your fulfillment stream? The answer is likely "no." Breaking through this sub-optimizing approach requires a new way of thinking and a new way of telling the critically important story of your fulfillment stream.TIN Matching program
1099 and W-9 Update - Complying with IRS Information Reporting : Learn the rules requiring W-9 documentation and 1099 reporting. Learn how to establish the independent contractor relationship with the right documentation. Understand the rules and keep your company in compliance.
TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties : Join us for a content-rich 90-minutes and you will gain the tools to make you the most effective information return manager your company has ever seen.AerospaceAS9100 vs ISO 9001
Aerospace - AS9100 vs ISO 9001 : AS9100 was released in 1999, and was based on ISO 9001. As many different organizations wanted a standard for their industry, ISO 9001 did not cover all of the aspects needed to ensure safe materials and manufactured goods were acceptable for their aerospace applications.
Conference about Enroute Air Traffic Control - ATC in the World of Contrails : Overview: The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace.
Webinar on Terminal Radar Approach Control TRACON Operations : Overview: Many people believe that communications, navigation, surveillance, and automation technologies are the elements of the complete ATC system when, in fact, they are simply the enabling technologies that allow the air traffic control function to perform efficiently and safely.Canadian Establishment LicensesDrugs, Supplements and Medical Devices
483 Covers a Broad Gradation of Problems : The 483 and the inspection report provide the factual foundation for the FDA to determine whether official action is appropriate.
7 Megatrends that Will Transform the Global Marketplace : The trends will impact virtually every industry that is dependent on supply chains. There is a convergence of supply chain trends that will dramatically change the global marketplace.
Agile Meets Software Standards and We all Win : Understanding TIR 45 can be the roadmap for improving development and benefiting everyone, companies, development teams, caregivers, patients, and regulators.
Auditing of CMOs 3rd Party and Subcontractors : Audits become an effective means of evaluating compliance with the objectives of the quality system especially when concern suppliers and outsourcing operations like CMO's, service providers, sub-contractors and raw materials suppliers.
Canadian Establishment Licenses Drugs Supplements and Medical Devices : Seminar will also include some instruction on how to best use the Health Canada website for these licenses, and how to stay on track and receive the latest updates as they become available. An introduction to Health Canadaa s newly proposed consultation document Consumer Health Products Framework will be introduced along with a brief discussion of its relevance to the current establishment license procedures in Canada.
Compliance for Computer Systems Regulated by FDA - 2017 : Overview: The Webinar will focus on the importance of ensuring that electronic record/ electronic signature (ER/ ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. Why should you Attend: This Webinar will help you understand in detail the application of FDA's 21 CFR more...
Conference about EHS Leading Indicators - Facing Front While Looking Back : This session describes what a leading indicator is, how to use it, and how to measure it. We ask ourselves a I know what went wrong because I investigated it and tracked it", but how do I know a 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.
Conference about FDA New Drug Approval Process : In the calendar year 2015, the pharmaceutical industry witnessed the largest number of Food and Drug Administration (FDA) prescription drug approvals in the past decade. The FDA's Center for Drug Evaluation and Research played a valuable and key role in bringing these drugs to market.
Conference about Generating Political and Community Support During the Regulatory Permitting Process : The regulatory process can be mired in opposition derived from NIMBYa s, environmentalists, competitors and a variety of other reasons. You typically have to generate support from within the community in order to counter opponents to your specific development, this can cost time and resources and unless you understand the political nuances, being successful is a difficult task.
Conference about Normality Tests and Normality Transformations Explanations : 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.
Conference about Orphan Medicinal Product Designation in the EU : The European Medicines Agency plays a central role in the development and authorization of medicines for rare diseases. These medicines are termed a orphan medicinesa in the medical world. It is estimated that today in the EU, 5-8000 distinct rare diseases affect 6-8% of the population - about 30 million people.
Current Status of Biosimilars in US Europe and Canada : We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.
Dietary Supplement Health and Education Act of 1994 : FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.
Essentials of Validation -IQOQPQ : In this webinar you will learn the benefits and impacts of validation and how it can benefit your customers and your business, and also you'll learn the essentials of validation planning, protocol writing, and change management.
FDA current recommendations on using electronic health records - 2017 : Overview: This webinar will discuss FDA's current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination product.
Final FDA Guidance Form FDA 1572 : This guidance applies to clinical investigations conducted under 21 CFR Part 312.
Final Rules of Unique Device Identification : Overview: This webinar will address the four key steps to compliance by device manufacturers. Also covered will be the Final Rule's provisions to address existing FG inventory, not properly labeled.
Food Technology for Non-Technologists : In this webinar speaker will explain about Internal Audit Team Members, those planning to become Internal Auditors in the food industry and Consultants.
FSMA Impact to the Transportation of Perishables Training by Compliance4All : This webinar is designed to help you understand how the new rules for the sanitary transportation of human and animal foods will impact your logistics operations and to provide you with some of the tools needed to meet new regulations and customer demands.
How Ensuring Data Integrity in Method Validations : Overview: The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements to ensure Data Integrity.
How software requirements are used in validation : 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 to Manage a Medical Device Recall Training by Compliance4All : 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.
Lean Documents and Lean Configuration - 2017 : The webinar will first present the key differences between ISO 13485 2015 versus ISO 13485 2003.
Meeting your Regulatory and Processing Responsibilities : In this session speaker will discuss - Why DMFs are important to you and your company , and How DMFs fit into FDA's regulatory processes for review of drug and biologic applications.
Optimizing Process Behavior Using Design of Experiments : 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.
Pest Control in Food Processing and Foodservice - 2017 : In this webinar you'll learn how pest control practices are essential for protecting consumers from unhealthy food.
Phase I GMPs clinical trials - 2017 : Overview: Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product.
Process or Equipment and QMS Software 2017 : 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".
Regulatory Compliance by Implementing the Cost Effectively - 2017 : Best practices should be determined for "like" operations, equipment, processes, etc. and then implemented across all facilities and locations where those "like" operations exist.
Requirements and Available Options for Achieving Compliance : In this session you will learn how to calculate serving sizes and declare correct calorie counts for standard menu items, and also learn how to make calorie and nutrient declarations using the principle of reasonable basis.
To Facilitate a Closed-Loop Problem Resolution System : This webinar will help you understand the critical ingredients for conducting an effective root cause analysis, also you will learn how to Analyze and document the root cause of the problem.
USP Chapter 1224 for Transfer of Analytical Methods : 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.
Webinar on 2011 FDA Guideline on Process Validation : 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.
Webinar on 21st Century Validation : Overview: The 'why' and 'what' and the events / background that have impacted validation over the last 25 years will be presented.
Webinar on About The Requirements of The NI 43-101 : National Instrument 43-101 is a national instrument for the Standards of Disclosure for Mineral Projects within Canada. The Instrument is a codified set of rules and guidelines for reporting and displaying information related to mineral properties owned by, or explored by, companies which report these results on stock exchanges within Canada.
Webinar on Cyber Security Mitigation and Response Risk Assessment : An organization's security policy and controls must be adaptable to emerging threats in today's world. The assessment of security threats is ongoing, and must be mapped against the adequacy and existence of security controls.
Webinar on Development and Implementation of an External Auditing Program as part of a Pharmaceutical Manufacturing Quality Syst : The presentation will explain the need and implementation of a pharmaceutical manufacturing external auditing program as part of an overall GMP compliant Quality System.
Webinar on Driving a Quality-Lean Steering Committee : This session demonstrates how to develop, manage, and implement an effective quality Lean Management System (QLMS) steering committee. Attendees will observe the development of the key components of a steering committee.
Webinar on FDA Regulation of Medical Device Software : 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).
Webinar on Introduction to SPC Statistical Process Control : 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 be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".
Webinar on Regulatory Aspects of Advanced Therapy Medicinal Products in the EU : Overview: Advanced therapy medicinal products are human cells and tissues or products with a genetic mode of action; they generate huge expectations but are also associated to new significant threats including tumorigenicity, cell (de)differentiation, and patient integration.
Webinar on Setting the ideal cGMP HVAC Design Requirements for Pharmaceutical Sterile and Sterile Facilities : It was observed that there are misunderstanding between design intent HVAC designer and User (who is working on the field) where each party is focusing on his area!
What to Do When Its Not a Bell Curve - 2017 : Overview: Statistical textbooks, manuals, and even most software rely on the assumption that processes conform to the normal or bell curve distribution.
Why are we Seeing More Independent Data Safety Monitoring : In this webinar speaker will discuss the purpose of the Data and Safety monitoring plan, and Importance of avoiding a Conflict of interest in the DMC members.
Why Capturing Justifications in Change Control : Overview: It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to explain or justify why it should be done or why a product should be released or rejected as a result.Clinical ComplianceRegulation
2016 webinar on Exporting Marketing Channel Audits : This training will address the export audit compliance procedures that will emphasize what appropriate documentation that are often used in the country market system and its product competitiveness research methods for conducting trade transactions.
Clinical Data Systems Regulated by FDA : This webinar will benefit those involved in the conduct of clinical trials, audit and inspection of clinical trial study data and records.
Conference about Creating High Performance Expectations Of People HPE : 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.
Conference about Designing full Cyber Security Incident Response Team CSIRT Training and Testing : Many companies have never trained their response teams and never tested their Cyber Security Incident Response Team Program. The reason that so many companies have failed to respond in a quick efficient manner, is poor preparation. Attackers attack 24x7 and Computer Security Incident Response for a company, government agency or organization must also be ready 24X7.
Conference about Discover How You Can Remove the Risk of Harmful Employee Conflict : This program was developed for leaders at all levels of an organization. It merges the topics of risk management and employee engagement into a solution on how to manage employees whose behaviors negatively influence others. This material has been road tested and is highly rated.
Conference about Managing Non-Conformance and Corrective Actions : Root Cause is an essential component for addressing non-conformance. It uses a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can: Determine what happened. Determine why it happened. Figure out what to do to reduce the likelihood that it will happen again.
Conference about Performance Evaluations May be Hazardous to Your Companys Success and Employee Longevity : This program was developed for leaders at all levels of an organization. It merges the topics of risk management and employee performance evaluations into a solution for better employee performance and loyalty.
Conference about Pre-Control Easier than SPC : 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.
Conference about Risk Management - Eliminate the Hidden Traps to Project Success : The key to minimizing risk is knowing what you don't know. Notice I said minimizing risk, because construction by its very nature has risk. We are always doing something new. Therefore, the program why explains the key fundamental to avoiding is to rely on experts.
Corrective and Preventive Action CAPA Webinar by Compliance4all : Medical Device managers, engineers, QA personnel, as well as lean program leaders. Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA)which is often redundant, repetitive, and chained together in a cumbersome way?
International Regulatory Cooperation Among Agencies : This presentation will review what we know of how regulatory agencies are working together internationally to share best practices in reviewing drugs.
Spreadsheets in FDA Regulated Environments webinar by Compliance4All : Excel ® Applications are widely used in laboratories, offices and manufacturing e. g., for data capture, data manipulation and report generation. Regulations such as FDA's GxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality.
The Value of a Human Factors Program : This webinar will help to sort through the confusion of the standard and help meet regulatory expectations by enumerating the tasks necessary to build a robust Risk based Human Factors program.
Understanding Autism Spectrum Disorder Webinar by Compliance4all : This is an interactive overview of how DMAIC can be utilized in a home environment to improve the quality of life for a child diagnosed as being on the Autism Spectrum.Clinical trial and researchGood clinical practice
21 CFR Part 820 - Quality System Regulation : Overview: In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820.
Goldratts Theory of Constraints - 2017 : A short cycle time may make the difference between manufacturing to order and manufacturing to meet uncertain sales forecasts.
Good Clinical Practice GCP : GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates.
Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs : This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
Navigating the New European Clinical Trial Regulation Webinar by Compliance4all : This course covers the newly proposed requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation 536/ 2014 (for Drugs, Biologics & Combination Products).
Practices for Active Pharmaceutical Ingredients per ICH Q7 : Overview: The APIs covered in this guidance document include new chemical entities and APIs of biological origin and those created by biotech processes.
Webinar on A second look at 510k changes : Overview: 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).constructionconstruction webinar
Avoiding Pitfalls With Air Barriers : This workshop will review the proper planning, product selection, specifications, details and field quality assurance needed for a successful air barrier installation.
Client Expectations Without Losing Your Shirt or the Next Job - 2017 : Many times this can be done without having to give back money.
Design Inputs Design Outputs Traceability Matrix - 2017 : This webinar presents a new approach yet is based on solid principles and proven practices.
Fremont 2016 Webinar on Avoiding Pitfalls With Spray Foam Insulation : The use of spray polyurethane foam insulation in building construction has increased dramatically over the past decade because of its superior insulating qualities, performance and ability to provide all four barrier needed to effectively separate the interior environment form the exterior environment.