- 22
- March
- 2023
- Wednesday
FDA's New Import Program for 2022 and Impact of the COVID-19
In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Casper Uldriks |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 22
- March
- 2023
- Wednesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 22
- March
- 2023
- Wednesday
3-Hour Virtual Seminar: SOP Writing, Training and Compliance in the Pharmaceutical Industry
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Michael Esposito |
Duration: 3 Hours |
Price: $299.00
| View Details
- 22
- March
- 2023
- Wednesday
6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
John E Lincoln |
Duration: 6 Hours |
Price: $545.00
| View Details
- 22
- March
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 22
- March
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 22
- March
- 2023
- Wednesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 23
- March
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 24
- March
- 2023
- Friday
Excel - Formulas and Functions 101
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Mike Thomas |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 24
- March
- 2023
- Friday
Writing Excellent SOPs
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Susanne Manz |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 24
- March
- 2023
- Friday
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 24
- March
- 2023
- Friday
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 |
Duration: 2 Hours |
Price: $199.00
| View Details
- 28
- March
- 2023
- Tuesday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 29
- March
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 29
- March
- 2023
- Wednesday
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 |
Duration: 3 Hours |
Price: $299.00
| View Details
- 29
- March
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 29
- March
- 2023
- Wednesday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 29
- March
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 30
- March
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 30
- March
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 30
- March
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 30
- March
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 30
- March
- 2023
- Thursday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 30
- March
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 31
- March
- 2023
- Friday
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 |
Duration: 3 Hours |
Price: $299.00
| View Details
- 31
- March
- 2023
- Friday
Failure Investigation and Root Cause Analysis
Closed-loop CAPA mandates a repeatable, systematic Failure Investigation and Root Cause Analysis.
John E Lincoln |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 3
- April
- 2023
- Monday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 4
- April
- 2023
- Tuesday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 4
- April
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 4
- April
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 5
- April
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 5
- April
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 5
- April
- 2023
- Wednesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 5
- April
- 2023
- Wednesday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 5
- April
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 5
- April
- 2023
- Wednesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 6
- April
- 2023
- Thursday
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 |
Duration: 3 Hours |
Price: $299.00
| View Details
- 6
- April
- 2023
- Thursday
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 |
Duration: 75 Minutes |
Price: $149.00
| View Details
- 6
- April
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 6
- April
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 7
- April
- 2023
- Friday
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 |
Duration: 3 Hours |
Price: $299.00
| View Details
- 7
- April
- 2023
- Friday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 7
- April
- 2023
- Friday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 10
- April
- 2023
- Monday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 11
- April
- 2023
- Tuesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 11
- April
- 2023
- Tuesday
Writing Excellent SOPs
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Susanne Manz |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 11
- April
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 11
- April
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 11
- April
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 12
- April
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 13
- April
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 13
- April
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 13
- April
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 13
- April
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 13
- April
- 2023
- Thursday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 17
- April
- 2023
- Monday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 17
- April
- 2023
- Monday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 17
- April
- 2023
- Monday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 18
- April
- 2023
- Tuesday
Excel - Power Query for the Everyday Excel User - Part 1
Turn bad data into great data in minutes!
Mike Thomas |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 18
- April
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 19
- April
- 2023
- Wednesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 19
- April
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 20
- April
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 21
- April
- 2023
- Friday
Essentials of Validation - IQ OQ PQ
Validation is an important element of the Quality System Regulations and ISO13485.
Susanne Manz |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 21
- April
- 2023
- Friday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 24
- April
- 2023
- Monday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 24
- April
- 2023
- Monday
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 |
Duration: 3 Hours |
Price: $299.00
| View Details
- 25
- April
- 2023
- Tuesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 25
- April
- 2023
- Tuesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 27
- April
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 28
- April
- 2023
- Friday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 28
- April
- 2023
- Friday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 28
- April
- 2023
- Friday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 2
- May
- 2023
- Tuesday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 3
- May
- 2023
- Wednesday
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 |
Duration: 75 Minutes |
Price: $149.00
| View Details
- 4
- May
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 5
- May
- 2023
- Friday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 8
- May
- 2023
- Monday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 9
- May
- 2023
- Tuesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 12
- May
- 2023
- Friday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 12
- May
- 2023
- Friday
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 |
Duration: 4 Hours |
Price: $445.00
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- 24
- May
- 2023
- Wednesday
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 |
Duration: 4 Hours |
Price: $445.00
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- 25
- May
- 2023
- Thursday
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 |
Duration: 6 Hours |
Price: $545.00
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- 1
- June
- 2023
- Thursday
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 |
Duration: 4 Hours |
Price: $445.00
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- 7
- June
- 2023
- Wednesday
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 |
Duration: 2 Hours |
Price: $199.00
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