Webinar Search Results : 52 Upcoming webinars found.
Jeff Kasoff Friday, March 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jeff Kasoff
FDA Inspections - Do's and Don'ts
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

Susanne Manz Monday, March 25, 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.

John Chapman Tuesday, March 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Chapman
FMEA & Risk Management for Medical Devices
FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management.

Prof. Dr. h.c. Frank Stein Tuesday, March 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Prof. Dr. h.c. Frank Stein
ISO 13485 Quality Management System for Medical Device Industry; How to build a Quality Management System for the European Market?
Introduction, who should apply the ISO 13485:2016. Overview about the changes of the ISO 13485:2016. Explaining of each change. Smart and fast ways to implement the changes in your quality management system. Fast track internal audit to approve the changes.

Carolyn Troiano Thursday, March 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Computer System Validation (CSV) for FDA-Regulated Computers
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

Angela Bazigos Friday, March 29, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Boot Camp on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.

Jose Mora Tuesday, April 2, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records

Ginette Collazo Tuesday, April 2, 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.

Angela Bazigos Wednesday, April 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Audit Trail Generation and Review
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

John E Lincoln Wednesday, April 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John E Lincoln
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Steven Laurenz Wednesday, April 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Steven Laurenz
Understanding and Implementing a Technology Transfer Process
The purpose of this training is to provide you with an overview of the Technology Transfer. Define technology transfer. Identify New Product transfer process. Identify elements of the business process framework for managing technology transfers. Explain benefits of technology transfer. Determine elements of a successful technology transfer.

Charles H. Paul Wednesday, April 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
Successful Device Submissions and Approvals - Key Elements
The medical device market is the largest market of all of the life sciences and it is generally valued at upwards of $90 billion with the expectation of continuous growth. This growth demands that the market is continually fed with new and innovative products.

Jose Mora Thursday, April 4, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Jose Mora
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples

John Chapman Thursday, April 4, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Chapman
Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements
This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

Kelly Thomas Thursday, April 4, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Kelly Thomas
Aseptic Processing Overview and Validation
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

Ginette Collazo Friday, April 5, 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.

Kelly Thomas Monday, April 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Kelly Thomas
How to Write Effective 483 and Warning Letter Responses
This 90-minute course will discuss the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response.

Steven Wachs Monday, April 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Steven Wachs
Estimating Reliability Performance with Accelerated Life Tests
This webinar on Estimating Reliability Performance of products will show how you can use Accelerated Life Testing methods (ALT) to reduce costs, minimize risks and ensure adequate product performance prior to launch.

Angela Bazigos Monday, April 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Export Certificate for Medical Devices - Edge Out Your Competition!
Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply proof of the products' status as regulated by the FDA. An export certificate is a document prepared by FDA that has information about a product's regulatory or marketing status in the U.S.

Casper Uldriks Tuesday, April 9, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
FDA's New Import Program for 2019
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

Edwin Waldbusser Wednesday, April 10, 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.

David Nettleton Thursday, April 11, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: David Nettleton
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. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR).

Danielle DeLucy Thursday, April 11, 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.

Carolyn Troiano Monday, April 15, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar on Data Integrity and Governance for Computer Systems Regulated by FDA
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry.

Prof. Dr. h.c. Frank Stein Monday, April 15, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Prof. Dr. h.c. Frank Stein
MDSAP - How to Implement MDSAP-Requirements into your ISO 13485 Quality Management System?
This course will give an introduction into the Medical Device Single Audit Program (MDSAP).

John N. Zorich Tuesday, April 16, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John N. Zorich
Process Validation: Statistical Justification for Sample Size and the Use of Only 3 Lots
This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.

Todd B. Graham Wednesday, April 17, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Todd B. Graham
SOP's for Bioanalytical Methods Validation
The webinar will include the following critical information you will need:

Jose Mora Thursday, April 18, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.

Ginette Collazo Friday, April 19, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
This training program will offer attendees an understanding of human error, its factors and causes.

John E Lincoln Tuesday, April 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John E Lincoln
The Most Serious FDA 483s - How to Avoid them
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.

Susanne Manz Tuesday, April 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Susanne Manz
Turn a Culture of Quality Into a Competitive Advantage
A culture of quality is a powerful tool for creating an effective and efficient Quality Management System. A culture of quality is not accidental but can be purposefully nurtured and developed.

John Chapman Wednesday, April 24, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Chapman
Failure Modes and Effects Analysis - An effective Risk Management Tool
This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

Edwin Waldbusser Thursday, April 25, 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. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

Steven Wachs Thursday, April 25, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Steven Wachs
Fractional Factorial Experiments for Screening Studies
In this webinar attendees will learn the key concepts behind Design of Experiments (DOE) and the use of DOE for Process and Product Optimization.

Susanne Manz Tuesday, April 30, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
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.

Ginette Collazo Tuesday, April 30, 2019
09:00 AM PDT | 12:00 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.

Michael Abitz Wednesday, May 1, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
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.

Steven Laurenz Thursday, May 2, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Steven Laurenz
Quality Risk Management Overview
Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM.

Steven Wachs Tuesday, May 7, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Steven Wachs
Statistical Hypothesis Tests: Concepts and Applications
This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes.

John E Lincoln Wednesday, May 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John E Lincoln
Verification vs Validation-Product, Process or Equipment and QMS Software
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.

Edwin Waldbusser Thursday, May 9, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
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.

Prof. Dr. h.c. Frank Stein Monday, May 13, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Prof. Dr. h.c. Frank Stein
ISO 62304 How to Create a Medical Software Development File?
This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible.

Susanne Manz Monday, May 13, 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.

John N. Zorich Wednesday, May 15, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John N. Zorich
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Thomas Bento Thursday, May 16, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Thomas Bento
The Value of a Human Factors Program
This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.

Susanne Manz Thursday, May 16, 2019
12:00 PM PDT | 03:00 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. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.

Michael Abitz Tuesday, May 21, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Michael Abitz
Root Cause Failure Analysis Closed Loop Corrective Action
Root Cause Failure Analysis 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.

John N. Zorich Wednesday, May 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John N. Zorich
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.

Susanne Manz Wednesday, May 29, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
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.

Casper Uldriks Tuesday, June 25, 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.

Casper Uldriks Tuesday, July 16, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Casper Uldriks
3-Hour Virtual Seminar on FDA Imports Require Precision in 2019
Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct, or else, FDA's entry requirements with detain your product. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.

Casper Uldriks Tuesday, August 13, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
FDA's New Import Program for 2019
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

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