Webinar Search Results : 36 Upcoming webinars found.
Steve Gompertz Friday, September 20, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Steve Gompertz
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.

Charles H. Paul Monday, September 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Charles H. Paul
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.

Angela Bazigos Tuesday, September 24, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts
With the emerging utilization of computerized technologies in the late 1980s and early 1990s, the pharmaceutical industry asked the FDA for guidance regarding compliance of the resulting electronic records. After several years of development and industry comments, 21 CFR Part 11, the Electronic Records & Electronic Signatures Rule became law in 1997.

John N. Zorich Wednesday, September 25, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:2 Hours
Price: $190.00
by: John N. Zorich
2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Yuval Shapiro Wednesday, September 25, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Yuval Shapiro
Creating Optimal Sampling Plans
A sampling plan is a term widely used in research studies that provide an outline on the basis which of research is conducted. It tells which category is to be surveyed, what should be the sample size and how the respondents should be chosen out of the population.

Robert J. Russell Wednesday, September 25, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Robert J. Russell
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Danielle DeLucy Thursday, September 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Danielle DeLucy
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.

Edwin Waldbusser Thursday, September 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Edwin Waldbusser
How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.

Susanne Manz Friday, September 27, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Susanne Manz
3-Hour Virtual Seminar on Design Controls for Medical Devices
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.

Casper Uldriks Tuesday, October 1, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Casper Uldriks
Responsibility for Off-label Claims in Social Media
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

John E Lincoln Tuesday, October 1, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: John E Lincoln
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.

Susanne Manz Wednesday, October 2, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Susanne Manz
Quality is not an Organization
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Karl J Hemmerich Thursday, October 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Karl J Hemmerich
Accelerated Aging Techniques for Medical Device Packaging
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.

Steve Gompertz Thursday, October 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Steve Gompertz
Practical Training & Employee Competency 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. But, quality standards and regulations actually focus on employee competence and awareness of their impact on quality.

Yuval Shapiro Monday, October 7, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Yuval Shapiro
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. Prior to engaging the process of establishing and certifying a QMS for medical devices or enhancing the QMS to the newly introduced requirements, a review of those requirements and how to approach them is important.

Charles H. Paul Monday, October 7, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Charles H. Paul
Implementing Effective CAPA Systems
How CAPA's are executed and managed is crucial to maintaining a compliant organization. Inadequate CAPA processes continue to be a major GMP deficiency and consistently make the FDA's top five list for adverse observations.

Ginette Collazo Tuesday, October 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Ginette Collazo
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. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Edwin Waldbusser Wednesday, October 9, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Edwin Waldbusser
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. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.

Swasita Saigal Thursday, October 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Swasita Saigal
Conducting An Effective Recall (Managing Internal and External Customers)
The webinar will cover what it takes in conducting an effective recall. You will learn practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up or a regulatory action. You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business.

Susanne Manz Wednesday, October 16, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Susanne Manz
3-Hour Virtual Seminar on CAPA for Medical Devices
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

John E Lincoln Wednesday, October 16, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: John E Lincoln
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).

Ginette Collazo Friday, October 18, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Ginette Collazo
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. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.

Angela Bazigos Friday, October 18, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device
This presentation uses the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the predictability, consistency, and transparency of the "when to submit" decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.

Susanne Manz Monday, October 21, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Susanne Manz
Death By CAPA - Does your CAPA Program Need a CAPA?
This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.

Steve Gompertz Tuesday, October 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Steve Gompertz
The 7 Habits of Highly Effective Project Managers
Too often Project Leaders and Managers fall into the role due to demonstrated technical competence. After all, if you're competent enough to create great technical output, certainly you can figure out how to run a project on schedule and within budget, right? And even when you get an opportunity to attend training to become a better Project Manager, the focus is on the "hard" or technical aspects of project management rather than the "soft" skills or habits that typically only come with experience.

Swasita Saigal Tuesday, October 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Swasita Saigal
Managing Complaints, Small Business Perspective
This webinar will review GMP requirements for complaint handling. We will also discuss the types of complaints (adverse and non-adverse events) that may be received.

Edwin Waldbusser Wednesday, October 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Edwin Waldbusser
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. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Angela Bazigos Thursday, October 24, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Bootcamp on How the FDA are Trained for Medical Device Inspections
This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms. It will present the specific guidance FDA inspectors receive for each of the regulations.

Ginette Collazo Thursday, October 24, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Ginette Collazo
Tools for Human Error Reduction
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Susanne Manz Wednesday, October 30, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Susanne Manz
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. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

Angela Bazigos Wednesday, October 30, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions
The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.

Ginette Collazo Thursday, November 7, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Ginette Collazo
Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

John E Lincoln Wednesday, November 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: $150.00
by: John E Lincoln
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.

Angela Bazigos Wednesday, November 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Export Certificate for Medical Devices - Edge Out your Competition!
In today's global environment, sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the issues involved in managing regulations across different countries.

Angela Bazigos Thursday, November 21, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements
Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents.

Ginette Collazo Friday, November 22, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Ginette Collazo
Training in Human Error: Reducing Training Related Errors
We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.

  • Ginette Collazo Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Ginette Collazo
    Training in Human Error: Reducing Training Related Errors
    We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.

  • Ginette Collazo Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Ginette Collazo
    Controlling Human Error in the Manufacturing Floor
    Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

  • Ginette Collazo Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Ginette Collazo
    Tools for Human Error Reduction
    Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

  • Ginette Collazo Recorded
    View Anytime
    Duration:3 Hours
    Price: $340.00
    by: Ginette Collazo
    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. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.

  • Ginette Collazo Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Ginette Collazo
    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. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

  • Susanne Manz Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Susanne Manz
    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. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

  • Susanne Manz Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Susanne Manz
    Death By CAPA - Does your CAPA Program Need a CAPA?
    This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.

  • Susanne Manz Recorded
    View Anytime
    Duration:3 Hours
    Price: $340.00
    by: Susanne Manz
    3-Hour Virtual Seminar on CAPA for Medical Devices
    CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

  • Michael Abitz Recorded
    View Anytime
    Duration:60 Minutes
    Price: $190.00
    by: Michael Abitz
    Fishbone Diagramming
    Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

  • Susanne Manz Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Susanne Manz
    Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
    This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.

  • Susanne Manz Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Susanne Manz
    Quality is not an Organization
    What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

  • Edwin Waldbusser Recorded
    View Anytime
    Duration:60 Minutes
    Price: $190.00
    by: Edwin Waldbusser
    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. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

  • Susanne Manz Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Susanne Manz
    Essentials of Validation - IQ, OQ, PQ
    Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.

  • Michael Abitz Recorded
    View Anytime
    Duration:60 Minutes
    Price: $190.00
    by: Michael Abitz
    Fishbone Diagramming
    Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

  • Ginette Collazo Recorded
    View Anytime
    Duration:3 Hours
    Price: $340.00
    by: Ginette Collazo
    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. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.

  • Danielle DeLucy Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Danielle DeLucy
    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.

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