• 28
  • March
  • 2023
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Susanne Manz Susanne Manz | Duration: 4 Hours | Price: $445.00 | View Details
  • 29
  • March
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Project Management for Non-Project Managers - Scheduling your Project

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives.

Charles H. Paul Charles H. Paul | Duration: 60 Minutes | Price: $150.00 | View Details
  • 29
  • March
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

How to Prepare for and Host an FDA Inspection and Respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $150.00 | View Details
  • 29
  • March
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 29
  • March
  • 2023
  • Wednesday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

FDA steadily expands the scope and restrictions for the promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume you're talking to FDA.

Casper Uldriks Casper Uldriks | Duration: 3 Hours | Price: $290.00 | View Details
  • 29
  • March
  • 2023
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

Charles H. Paul Charles H. Paul | Duration: 6 Hours | Price: $545.00 | View Details
  • 30
  • March
  • 2023
  • Thursday
10:00 AM PDT | 01:00 PM EDT

How to Deal With Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 30
  • March
  • 2023
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $150.00 | View Details
  • 30
  • March
  • 2023
  • Thursday
12:00 PM PDT | 03:00 PM EDT

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $150.00 | View Details
  • 30
  • March
  • 2023
  • Thursday
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, and communication, among many others, will be discussed as part of this webinar.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 30
  • March
  • 2023
  • Thursday
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
  • 30
  • March
  • 2023
  • Thursday
08:00 AM PDT | 11:00 AM EDT

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.

John E Lincoln John E Lincoln | Duration: 4 Hours | Price: $445.00 | View Details
  • 31
  • March
  • 2023
  • Friday
09:00 AM PDT | 12:00 PM EDT

3-Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

Carolyn Troiano Carolyn Troiano | Duration: 3 Hours | Price: $290.00 | View Details
  • 31
  • March
  • 2023
  • Friday
10:00 AM PDT | 01:00 PM EDT

Failure Investigation and Root Cause Analysis

Closed-loop CAPA mandates a repeatable, systematic Failure Investigation and Root Cause Analysis.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $150.00 | View Details
  • 3
  • April
  • 2023
  • Monday
10:00 AM PDT | 01:00 PM EDT

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $150.00 | View Details
  • 4
  • April
  • 2023
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar 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.

Carolyn Troiano Carolyn Troiano | Duration: 6 Hours | Price: $545.00 | View Details
  • 4
  • April
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $150.00 | View Details
  • 4
  • April
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

CAPA: Corrective and Preventative Actions and Non-Conformances

If instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it.

Michael Brodsky Michael Brodsky | Duration: 60 Minutes | Price: $150.00 | View Details
  • 5
  • April
  • 2023
  • Wednesday
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
  • 5
  • April
  • 2023
  • Wednesday
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
  • 5
  • April
  • 2023
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Tom Fragale Tom Fragale | Duration: 6 Hours | Price: $545.00 | View Details
  • 5
  • April
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Medical Device Software Validation Meeting FDA Regulations

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

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $150.00 | View Details
  • 5
  • April
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

How to Write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 5
  • April
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Validation of HPLC/UPLC Methodologies

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 6
  • April
  • 2023
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Training Effectiveness: How to Develop Instruments to Measure Learning and Reduce Errors

Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though Training is considered the "vaccine for mistakes," Training is as good as its effectiveness.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 6
  • April
  • 2023
  • Thursday
10:00 AM PDT | 01:00 PM EDT

HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity, and personnel is crucial to protect the product from contamination.

Roger Cowan Roger Cowan | Duration: 75 Minutes | Price: $150.00 | View Details
  • 6
  • April
  • 2023
  • Thursday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.

Susanne Manz Susanne Manz | Duration: 3 Hours | Price: $290.00 | View Details
  • 6
  • April
  • 2023
  • Thursday
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
  • 7
  • April
  • 2023
  • Friday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Audit like the FDA

This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.

Susanne Manz Susanne Manz | Duration: 6 Hours | Price: $545.00 | View Details
  • 7
  • April
  • 2023
  • Friday
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
  • 7
  • April
  • 2023
  • Friday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

Mike Thomas Mike Thomas | Duration: 3 Hours | Price: $290.00 | View Details
  • 10
  • April
  • 2023
  • Monday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

Charles H. Paul Charles H. Paul | Duration: 6 Hours | Price: $545.00 | View Details
  • 11
  • April
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Project Management for Non-Project Managers - How to Effectively Monitor and Control your Project

This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 11
  • April
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Pivot Table Essentials for Data Analytics in Excel

A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $150.00 | View Details
  • 11
  • April
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $150.00 | View Details
  • 11
  • April
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Is it Microbiological Method Verification or Validation, or Just Semantics?

This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation in food/water microbiology. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses.

Michael Brodsky Michael Brodsky | Duration: 60 Minutes | Price: $150.00 | View Details
  • 11
  • April
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Dealing with Difficult Customers Effectively

People and communications skills are very important in dealing with customers, but have little connection to doing good lab work. This webinar points out some approaches and skills to connect the two areas.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 11
  • April
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $150.00 | View Details
  • 12
  • April
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Linking Techniques In Depth In Excel

ObjectLinking and Embedding (OLE) make content that is created in one location or program available in another program. Using MS Excel you can link or reference to other cells in a worksheet or other worksheets, external workbooks, external files, and pages on the internet or your intranet, a valuable and marketable skill.

Ray Evans Ray Evans | Duration: 75 Minutes | Price: $150.00 | View Details
  • 12
  • April
  • 2023
  • Wednesday
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
  • 13
  • April
  • 2023
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Mastering Data and Information Management Essentials

Skills to effectively manage, present and communicate data are now vital in the competitive financial and business analysis fields and offer vast opportunities to expand accounting client services and career paths.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $150.00 | View Details
  • 13
  • April
  • 2023
  • Thursday
08:00 AM PDT | 11:00 AM EDT

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Susanne Manz Susanne Manz | Duration: 4 Hours | Price: $445.00 | View Details
  • 13
  • April
  • 2023
  • Thursday
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
  • 13
  • April
  • 2023
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Computer System Validation (CSV) and Computer Software Assurance (CSA): Future Trends in Validation

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $150.00 | View Details
  • 13
  • April
  • 2023
  • Thursday
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
  • 13
  • April
  • 2023
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and Combination Products in Japan.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 14
  • April
  • 2023
  • Friday
10:00 AM PDT | 01:00 PM EDT

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Ray Evans Ray Evans | Duration: 60 Minutes | Price: $150.00 | View Details
  • 17
  • April
  • 2023
  • Monday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.

Casper Uldriks Casper Uldriks | Duration: 6 Hours | Price: $545.00 | View Details
  • 17
  • April
  • 2023
  • Monday
12:00 PM PDT | 03:00 PM EDT

C for Yourself: The 5 C’s of Credit

The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $150.00 | View Details
  • 17
  • April
  • 2023
  • Monday
10:00 AM PDT | 01:00 PM EDT

Excel - 10 Must-Know Functions to Boost Your Productivity

Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.

Mike Thomas Mike Thomas | Duration: 90 Minutes | Price: $150.00 | View Details
  • 18
  • April
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Excel - Power Query for the Everyday Excel User - Part 1

Turn bad data into great data in minutes!

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 18
  • April
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Verification or Validation of Methods in Food Microbiology

Although method validation and method verification are related terms, they have very different analytical and statistical requirements, particularly for compliance with ISO/IEC 17025:2005. Unfortunately, the terms are often incorrectly used interchangeably, resulting in confusion and the application of inappropriate or inadequate analytical evaluations.

Michael Brodsky Michael Brodsky | Duration: 60 Minutes | Price: $150.00 | View Details
  • 19
  • April
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Project Management for Non-Project Managers - Project Management in Drug Development

It is important for a project manager to understand how the project management process integrates into drug development because drug development is a complex and highly regulated process that involves various stages, including discovery, pre-clinical development, clinical development, regulatory submission, and post-marketing surveillance.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 19
  • April
  • 2023
  • Wednesday
12:00 PM PDT | 03:00 PM EDT

Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $150.00 | View Details
  • 19
  • April
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Medical Device Cybersecurity following latest FDA Guidance

The company must establish a program where they identify, analyze and control cybersecurity risks for both pre-market and post-market. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to devise users.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $150.00 | View Details
  • 20
  • April
  • 2023
  • Thursday
10:00 AM PDT | 01:00 PM EDT

How to Deal with Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $150.00 | View Details
  • 21
  • April
  • 2023
  • Friday
10:00 AM PDT | 01:00 PM EDT

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $150.00 | View Details
  • 21
  • April
  • 2023
  • Friday
10:00 AM PDT | 01:00 PM EDT

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $150.00 | View Details
  • 24
  • April
  • 2023
  • Monday
08:00 AM PDT | 11:00 AM EDT

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

This virtual seminar 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: 6 Hours | Price: $545.00 | View Details
  • 24
  • April
  • 2023
  • Monday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on How to Establish Procedures for Medical Device Companies

Almost every paragraph of the Quality System Regulation for medical devices says that manufacturers shall "establish" procedures. This seminar will cover the expectations of the word "establish" and how to meet those expectations. Well-written SOPs are critical to show regulators that you have established procedures.

Susanne Manz Susanne Manz | Duration: 3 Hours | Price: $290.00 | View Details
  • 25
  • April
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

How to Write SOP's for Human Error Reduction

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

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $150.00 | View Details
  • 25
  • April
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

ISO-IEC 17025:2017 Update Introduction: Everything Old is New Again

Many laboratories have successfully developed and implemented a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs.

Michael Brodsky Michael Brodsky | Duration: 90 Minutes | Price: $150.00 | View Details
  • 27
  • April
  • 2023
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $150.00 | View Details
  • 27
  • April
  • 2023
  • Thursday
12:00 PM PDT | 03:00 PM EDT

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy-to-use flexible summary reports using Pivot Tables and Charts. We will start with the basics and build up to more complex pivot tables.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $150.00 | View Details
  • 28
  • April
  • 2023
  • Friday
10:00 AM PDT | 01:00 PM EDT

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

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $150.00 | View Details
  • 28
  • April
  • 2023
  • Friday
12:00 PM PDT | 03:00 PM EDT

Part 1- How to Write Right for Better Business Communication

Good leaders walk the talk, but they also “write right”. They know how to say in a few words what needs to be said in crisp, clear language. The road to bad communication is paved with good intentions but poor construction. Readers know when subjects and verbs don’t agree when punctuation misses the point when words don’t fit, and content is confusing. In this session, learn how a few basic rules on grammar, punctuation, and usage can improve business written communications with clearer, more succinct content.

Dev Strischek Dev Strischek | Duration: 90 Minutes | Price: $150.00 | View Details
  • 28
  • April
  • 2023
  • Friday
10:00 AM PDT | 01:00 PM EDT

Project Management for Non-Project Managers - The Project Management process in the development of In Vitro Diagnostics

Effective project management is essential in the development of In Vitro diagnostics. It ensures the timely completion of the project, and the efficient use of resources, coordination of teams, risk management, and quality management.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 28
  • April
  • 2023
  • Friday
10:00 AM PDT | 01:00 PM EDT

Excel - Creating an Interactive Dashboard

No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, its flexibility, and the fact that most people have it installed on their computers.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 2
  • May
  • 2023
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

Carolyn Troiano Carolyn Troiano | Duration: 4 Hours | Price: $445.00 | View Details
  • 2
  • May
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Formulas Automatic Calculation and Key Functions in Excel

Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel at the introductory level.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $150.00 | View Details
  • 3
  • May
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

This interactive webinar provides explicit details and a live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP-compliant spreadsheet application.

David Nettleton David Nettleton | Duration: 75 Minutes | Price: $150.00 | View Details
  • 4
  • May
  • 2023
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Making your Excel Spreadsheet much Easier to use with Tables

Tables are a powerful Excel functionality to streamline many data management functions.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $150.00 | View Details
  • 4
  • May
  • 2023
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.

Susanne Manz Susanne Manz | Duration: 60 Minutes | Price: $150.00 | View Details
  • 5
  • May
  • 2023
  • Friday
10:00 AM PDT | 01:00 PM EDT

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $150.00 | View Details
  • 8
  • May
  • 2023
  • Monday
10:00 AM PDT | 01:00 PM EDT

Project Management for Non-Project Managers - Role of Project Management in Quality Planning throughout the Medical Device Project Lifecycle

Project management plays a critical role in ensuring quality planning and management throughout the product lifecycle. The project manager is responsible for creating a comprehensive quality management plan, implementing quality control procedures, and identifying areas for continuous improvement. By doing so, they ensure that the final product meets the quality objectives and customer requirements.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 8
  • May
  • 2023
  • Monday
10:00 AM PDT | 01:00 PM EDT

Excel - Quick Tips to Help You be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

Mike Thomas Mike Thomas | Duration: 90 Minutes | Price: $150.00 | View Details
  • 9
  • May
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Pivot Table Essentials for Data Analytics in Excel

A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $150.00 | View Details
  • 9
  • May
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $150.00 | View Details
  • 12
  • May
  • 2023
  • Friday
08:00 AM PDT | 11:00 AM EDT

4-Hour Virtual Seminar on Improving Your CAPA Program - And preparing for upcoming changes to the Quality System Regulation

The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This seminar will help you prepare for upcoming changes to the QSR and improve your CAPA process.

Susanne Manz Susanne Manz | Duration: 4 Hours | Price: $445.00 | View Details
  • 12
  • May
  • 2023
  • Friday
09:00 AM PDT | 12:00 PM EDT

Part 2- How to Write More Effective Emails - Improving Your E-Communication Skills

Emails are a core business communication tool. The speed and volume of email have dramatically changed business communication. The not-so-old standards for professional correspondence have changed and will continue to do so. Employees need to know the best strategies to communicate effectively. An effective business email is easily understood, but it is not so easily written.

Dev Strischek Dev Strischek | Duration: 90 Minutes | Price: $150.00 | View Details
  • 16
  • May
  • 2023
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Project Management for Non-Project Managers - Project Management as applied to Clinical Trials

Clinical trial project management is a complex and dynamic process that requires careful planning, coordination, and communication among stakeholders.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 24
  • May
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

4-Hour Virtual Seminar on How to Write Better Communications and Emails

Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.

Dev Strischek Dev Strischek | Duration: 4 Hours | Price: $445.00 | View Details
  • 25
  • May
  • 2023
  • Thursday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Purchasing and Supplier Controls

This 6-hour virtual seminar can help you understand your responsibilities in terms of Purchasing Controls and Supplier Management enabling you to provide safe and effective products to your customers.

Susanne Manz Susanne Manz | Duration: 6 Hours | Price: $545.00 | View Details
  • 31
  • May
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Project Management for Non-Project Managers - Project Management in the Biomedical Industry

It is not possible to present a complete treatment of project management for this industry in the span of 90 minutes. It is however possible to focus on those most critical project management aspects that are critical to the success of any project within biotechnology and the biomedical industry in general.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $150.00 | View Details
  • 1
  • June
  • 2023
  • Thursday
10:00 AM PDT | 01:00 PM EDT

4-Hour Virtual Seminar on Credit Risk Management- Principles and Practices, Tools and Techniques

Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives.

Dev Strischek Dev Strischek | Duration: 4 Hours | Price: $445.00 | View Details
  • 7
  • June
  • 2023
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification

This 2-Hour Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

David Nettleton David Nettleton | Duration: 2 Hours | Price: $190.00 | View Details
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