• 29
  • May
  • 2020
  • Friday
09:00 AM PDT | 12:00 PM EDT

Regulatory Challenges of Real-world Artificial Intelligence (AI) and Machine Learning (ML)

This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.

Angela Bazigos Angela Bazigos | Duration:90 Minutes | Price: $150.00 | View Details
  • 29
  • May
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

FDA Audit Best Practices - Do's and Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Charles H. Paul Charles H. Paul | Duration:60 Minutes | Price: $150.00 | View Details
  • 29
  • May
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

ISO 14001: What is Emergency Preparedness and Response?

With any environmental management system (EMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.

Mark Hammar Mark Hammar | Duration:60 Minutes | Price: $150.00 | View Details
  • 29
  • May
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Supply Chain Failures Impact to Food Safety and Quality 2020

One of the three most critical food safety issues facing the food industry today is supply chain failures. With the U.S. initiated tariff wars activated, many types of food shipments are being and are likely to be impacted.

John Ryan John Ryan | Duration:60 Minutes | Price: $150.00 | View Details
  • 29
  • May
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Robert J. Russell Robert J. Russell | Duration:90 Minutes | Price: $150.00 | View Details
  • 29
  • May
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Management Responsibility and Management Review for a Suitable and Effective Quality Management System

In the highly regulated medical device industry, management responsibility and management review are critical concepts in ensuring a suitable Quality Management System (QMS).

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 1
  • June
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Hazardous Material Release Reporting Requirements

Hazardous materials pose a danger to the environment. Federal regulations require immediate reporting to specific agencies (federal and local) in the event of a release to the environment.

Robert A. (Bob) LaRosa Robert A. (Bob) LaRosa | Duration:60 Minutes | Price: $150.00 | View Details
  • 2
  • June
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications.

David Nettleton David Nettleton | Duration:90 Minutes | Price: $150.00 | View Details
  • 2
  • June
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Managing External Audits & Inspections

External audits often create a sense of dread or even panic. This is often followed by a frenzied scramble to get everything straightened out, cleaned up, or hidden away that might be cited by the Auditor.

Steve Gompertz Steve Gompertz | Duration:60 Minutes | Price: $150.00 | View Details
  • 2
  • June
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

GMP 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.

Roger Cowan Roger Cowan | Duration:60 Minutes | Price: $150.00 | View Details
  • 3
  • June
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Using Business Tax Returns For Credit Analysis

Tax Returns include both profit and Loss Statements and Balance Sheets as well as schedules and attachments which tell a great deal about the performance of a business.

Vincent DiCara Vincent DiCara | Duration:90 Minutes | Price: $150.00 | View Details
  • 3
  • June
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

ISO13485: 2016 - Quality Management Systems for Medical Devices

This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.

Yuval Shapiro Yuval Shapiro | Duration:90 Minutes | Price: $150.00 | View Details
  • 4
  • June
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Introduction to Bioresearch Monitoring

FDA's bioresearch monitoring program 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.

Thomas E. Colonna Thomas E. Colonna | Duration:60 Minutes | Price: $150.00 | View Details
  • 5
  • June
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Customer Relationship Management: Mastering Profitable Relationships!

Who would you like to influence more effectively? Your manager? Co-workers? Employees? Key customers? Suppliers? Whether you need to influence someone to go along with your ideas, to make and keep commitments, to help you complete a task, or to cooperate in a team endeavor, your success is greatly influenced by your ability to use your personal power and communication skills effectively.

Chris Devany Chris Devany | Duration:90 Minutes | Price: $145.00 | View Details
  • 8
  • June
  • 2020
  • Monday
12:00 AM PDT | 03:00 PM EDT

Best Practices for Deviation Investigations

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.

Danielle DeLucy Danielle DeLucy | Duration:60 Minutes | Price: $150.00 | View Details
  • 8
  • June
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.

Robert J. Russell Robert J. Russell | Duration:90 Minutes | Price: $150.00 | View Details
  • 9
  • June
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.

Ginette Collazo Ginette Collazo | Duration:90 Minutes | Price: $150.00 | View Details
  • 10
  • June
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

The Human Error Tool Box: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Ginette Collazo Ginette Collazo | Duration:90 Minutes | Price: $150.00 | View Details
  • 10
  • June
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Preventing Human Error in the Life Sciences

This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.

Charles H. Paul Charles H. Paul | Duration:60 Minutes | Price: $150.00 | View Details
  • 10
  • June
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices.

Edwin Waldbusser Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 | View Details
  • 10
  • June
  • 2020
  • Wednesday
12:00 PM PDT | 03:00 PM EDT

Smart Recruitment: How to Attract, Interview and Hire the Best Candidates

Does your hiring process consist of proven practices or just a hodgepodge of activities that get into gear when someone says, "I need more people" or "Sally has left and we need someone to take her place NOW?" The effectiveness of the recruitment process impacts the effectiveness of the organization.

Marcia Zidle Marcia Zidle | Duration:60 Minutes | Price: $145.00 | View Details
  • 11
  • June
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

How to Meet the Requirements of Form CRS (Client Relationship Summary) for Investment

The US. Securities and Exchange Commission (“SEC”) adopted new rules and amendments as of June 5, 2019, requiring both Brokers and Investment Advisers to complete a Client Relationship Summary.

Lisa Marsden Lisa Marsden | Duration:60 Minutes | Price: $150.00 | View Details
  • 12
  • June
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Cross Contamination Flow through the Food Supply Chain

Most information and training surrounding food cross contamination is focused primarily on bacteria in the kitchen and the need to separate utensils and work area of one type of food from another.

John Ryan John Ryan | Duration:60 Minutes | Price: $150.00 | View Details
  • 12
  • June
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Production and Process Controls for Medical Device Companies

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce safe and effective products.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 15
  • June
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

John C. Fetzer John C. Fetzer | Duration:60 Minutes | Price: $150.00 | View Details
  • 15
  • June
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Using Statistics to Determine Sample Size

We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.

Steven Wachs Steven Wachs | Duration:60 Minutes | Price: $150.00 | View Details
  • 17
  • June
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Dietary Supplements CGMPS - 21 CFR 111 Compliance

21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.

John E Lincoln John E Lincoln | Duration:90 Minutes | Price: $150.00 | View Details
  • 17
  • June
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Risk Management - Implementing ISO14971: 2019

Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.

Yuval Shapiro Yuval Shapiro | Duration:60 Minutes | Price: $150.00 | View Details
  • 17
  • June
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Meaningful Quality System Process Monitoring

When considering the requirements for process monitoring and measurement, the first thought is usually in regard to production processes. However, ISO 13485 and ISO 9001 require companies to monitor and measure all quality system processes.

Steve Gompertz Steve Gompertz | Duration:90 Minutes | Price: $150.00 | View Details
  • 18
  • June
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Classifying Your Products for International Trade: Plain Talk and Understanding

Importers must know how to classify imported products using the Harmonized Tariff Schedule of the United States (HTSUS). By becoming knowledgeable of the Harmonized System (HS), importers will know how to use the HTSUS properly.

Martin K. Behr, III Martin K. Behr, III | Duration:90 Minutes | Price: $150.00 | View Details
  • 18
  • June
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for contract Drug Manufacture

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.

Roger Cowan Roger Cowan | Duration:60 Minutes | Price: $150.00 | View Details
  • 22
  • June
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Handling OOS Test Results and Completing Robust Investigations

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.

Danielle DeLucy Danielle DeLucy | Duration:90 Minutes | Price: $150.00 | View Details
  • 23
  • June
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

The 6 Most Common Problems in FDA Software Validation and Verification

This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

David Nettleton David Nettleton | Duration:90 Minutes | Price: $150.00 | View Details
  • 24
  • June
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

How to Conduct a Human Factors/ Usability Validation

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation.

Edwin Waldbusser Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 | View Details
  • 24
  • June
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Responsibilities of the Carrier Under the Final FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

This is part 1 of a three part required training resulting from the finalization of new US FDA food transportation laws.

John Ryan John Ryan | Duration:60 Minutes | Price: $150.00 | View Details
  • 24
  • June
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Measurement, Analysis, and Improvement for safe and Effective Medical Devices

This 90 minute Webinar will cover the concepts of measurement, analysis, and improvement to ensure conformity of products, conformity of the management system, and on-going effectiveness.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 25
  • June
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Charles H. Paul Charles H. Paul | Duration:3 Hours | Price: $290.00 | View Details
  • 25
  • June
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

The Loan Review Process: Important Steps

The Loan Review Process is an important component of any successful commercial lending program. Although prudent underwriting before a loan decision has been made is key to building a strong loan portfolio, an incomplete or deficient loan review process can prove detrimental to the maintenance of that loan portfolio.

Vincent DiCara Vincent DiCara | Duration:90 Minutes | Price: $150.00 | View Details
  • 25
  • June
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Introduction to FDA Regulation of In Vitro Diagnostics

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.

Thomas E. Colonna Thomas E. Colonna | Duration:60 Minutes | Price: $150.00 | View Details
  • 26
  • June
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Drug Master Files: Understanding and Meeting your Regulatory Responsibilities

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

Robert J. Russell Robert J. Russell | Duration:90 Minutes | Price: $150.00 | View Details
  • 26
  • June
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Practical Training & Employee Competence Management

Training management is often focused only on aligning standard operating procedures with job titles, and tracking whether employees have been "trained" to the latest versions.

Steve Gompertz Steve Gompertz | Duration:90 Minutes | Price: $150.00 | View Details
  • 29
  • June
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Medical Device Risk Management following ISO 14971:2019

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post production risk management program be implemented.

Edwin Waldbusser Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 | View Details
  • 29
  • June
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

What You Need To Know About Export Compliance So That Your Company Can Stay in Business

Various U.S. governmental authorities have moved to mandatory compliance of all export regulations. Exporting has always been associated with intense documentation, bureaucracy, and much frustration.

Martin K. Behr, III Martin K. Behr, III | Duration:90 Minutes | Price: $150.00 | View Details
  • 30
  • June
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

John C. Fetzer John C. Fetzer | Duration:60 Minutes | Price: $150.00 | View Details
  • 30
  • June
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Human error is known to be the major cause of quality and production losses in many industries.

Ginette Collazo Ginette Collazo | Duration:90 Minutes | Price: $150.00 | View Details
  • 30
  • June
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

2020 IRS Representation Update

Over the past several years, the IRS has seen its budget cut significantly. There has been a corresponding reduction in the quality of service that it provides, including a dramatic cutback in its enforcement efforts.

Robert E. McKenzie Robert E. McKenzie | Duration:90 Minutes | Price: $150.00 | View Details
  • 30
  • June
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to meet FDA and International Quality Standards

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.

Roger Cowan Roger Cowan | Duration:60 Minutes | Price: $150.00 | View Details
  • 1
  • July
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Useful Statistical Methods for Defining Product and Process Specifications

Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.

Steven Wachs Steven Wachs | Duration:90 Minutes | Price: $150.00 | View Details
  • 8
  • July
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Batch Record Review and Product Release

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

Danielle DeLucy Danielle DeLucy | Duration:60 Minutes | Price: $150.00 | View Details
  • 8
  • July
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Standardizing Transportation Procedures to Control Food Safety and Quality

The course includes activities to help trainees develop a general plan and procedures to standardize and control food quality and safety transportation processes.

John Ryan John Ryan | Duration:60 Minutes | Price: $150.00 | View Details
  • 9
  • July
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries.

Ginette Collazo Ginette Collazo | Duration:90 Minutes | Price: $150.00 | View Details
  • 9
  • July
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Edwin Waldbusser Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 | View Details
  • 9
  • July
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Sample Size Determination for Design Validation Activities

Design Validation should ensure that product performance, quality, and reliability requirements are met.

Steven Wachs Steven Wachs | Duration:90 Minutes | Price: $150.00 | View Details
  • 10
  • July
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Say Goodbye to NAFTA: The USMCA is Now Here

The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes.

Martin K. Behr, III Martin K. Behr, III | Duration:90 Minutes | Price: $150.00 | View Details
  • 14
  • July
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Importing and Exporting by U.S. Mail and Express Consignment

The webinar will cover such topics as definitions of various articles related to U.S. Mail and express consignments; mail subject to Customs examination; exceptions to Customs examinations; general documentation and requirements; importations not over $800 in value; bona-fide gifts; dutiable packages; formal entries; costs of importing by mail; special classes of merchandise; restricted and prohibited merchandise; mail from insular possessions; articles returned for repair or alteration; special requirements for the import of food, plants, and animals; mail branches and examinations; export regulations and requirements, including AES, permits, licenses; marking and labeling.

Martin K. Behr, III Martin K. Behr, III | Duration:90 Minutes | Price: $150.00 | View Details
  • 15
  • July
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Root Cause Analysis - Starting at the Beginning

CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

John E Lincoln John E Lincoln | Duration:60 Minutes | Price: $150.00 | View Details
  • 17
  • July
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

2020 IRS Collection Procedures

This class will discuss the collection methods the IRS is using in the new enforcement environment. When clients are faced with IRS enforcement representatives need a wide array of skills to protect their clients.

Robert E. McKenzie Robert E. McKenzie | Duration:90 Minutes | Price: $150.00 | View Details
  • 20
  • July
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Determining Sample Size: What Sample Size Should I Use?

The webinar will provide important considerations when selecting sample sizes for specific applications.

Steven Wachs Steven Wachs | Duration:75 Minutes | Price: $150.00 | View Details
  • 21
  • July
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Medical Software Validation for the New FDA Inspections

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.

Edwin Waldbusser Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 | View Details
  • 21
  • July
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Traceability and Recall Through Food Processes

This webinar will cover traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls.

John Ryan John Ryan | Duration:60 Minutes | Price: $150.00 | View Details
  • 21
  • July
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

How to Get CBP to Classify Your Imports for Free: How to Design a Binding Ruling Request

U.S. Customs and Border Protection (CBP) can go back five (5) years and retroactively assess the correct duty rate for all product shipments during that time.

Martin K. Behr, III Martin K. Behr, III | Duration:90 Minutes | Price: $150.00 | View Details
  • 22
  • July
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Human Error Reduction in GMP Related Environments

Human error is known to be the primary cause of quality and production losses in many industries.

Ginette Collazo Ginette Collazo | Duration:3 Hours | Price: $290.00 | View Details
  • 24
  • July
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Non-Filer Representation

This presentation will cover the best methods to represent your non-filing clients. We will discuss IRS investigation techniques, IRC Sec. 6020B returns and substitutes for returns (SFR's), For fiscal year 2020 IRS has launched an aggressive initiative to pursue high income non-filers.

Robert E. McKenzie Robert E. McKenzie | Duration:90 Minutes | Price: $150.00 | View Details
  • 29
  • July
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

EU ISO 13485:2016 Medical Device Quality Management System

This webinar will examine the basic elements of the EU's QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical device industry QMS failings, as well as how ISO 13485 interfaces with the EU MDR (Medical Device Regulation).

John E Lincoln John E Lincoln | Duration:60 Minutes | Price: $150.00 | View Details
  • 30
  • July
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Importing and Exporting PPE: How to Deal with CBP, FDA, FEMA and Other Scary Agencies

The outbreak of coronavirus disease (COVID-19), first in the People's Republic of China (PRC or China), and now globally, including in the United States, is drawing attention to the ways in which the United States and other economies depend on critical manufacturing and global value chains that rely on production based in in the PRC and other countries.

Martin K. Behr, III Martin K. Behr, III | Duration:90 Minutes | Price: $150.00 | View Details
  • 31
  • July
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Reporting Name Foreign Financial Accounts

Many of our client's may be engaged in either cash transactions or have opened foreign bank accounts to avoid IRS scrutiny. This class will alert you to IRS enforcement efforts and the compliance requirements for foreign accounts.

Robert E. McKenzie Robert E. McKenzie | Duration:90 Minutes | Price: $150.00 | View Details
  • 4
  • August
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Project Management for FDA-Regulated Companies

This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.

John E Lincoln John E Lincoln | Duration:60 Minutes | Price: $150.00 | View Details
  • 7
  • August
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Gambling and Taxes: The Price of Winning

Most states now have some form of legalized gambling. Even in states without legalized gambling there are internet gamblers, those who travel to gambling venues and those who engage in illegal gambling.

Robert E. McKenzie Robert E. McKenzie | Duration:90 Minutes | Price: $150.00 | View Details
  • 26
  • August
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Verification vs Validation-Product, Process or Equipment and QMS Software

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.

John E Lincoln John E Lincoln | Duration:90 Minutes | Price: $150.00 | View Details
  • 8
  • September
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

John E Lincoln John E Lincoln | Duration:90 Minutes | Price: $150.00 | View Details
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