Webinar Search Results : 38 Upcoming webinars found.
John E Lincoln Tuesday, May 21, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: John E Lincoln
Device Changes, FDA Changes, and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

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.

Charles H. Paul Wednesday, May 22, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Charles H. Paul
3-Hour Virtual Seminar on Project Management for Non-Project Managers
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Danielle DeLucy Tuesday, May 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Danielle DeLucy
Implementation and Management of GMP Data Integrity
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.

Charles H. Paul Wednesday, May 29, 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
Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients.Human error is a frequent occurrence in pharmaceutical manufacturing.

John N. Zorich Wednesday, May 29, 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.

John E Lincoln Wednesday, May 29, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: John E Lincoln
3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements
This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF including its derivative documents, the DMR and DHR.

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.

Prof. Dr. h.c. Frank Stein Thursday, May 30, 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).

Wayne Taylor Friday, May 31, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Wayne Taylor
Medical Devices - Complying With 820.250 Statistical Methods
Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for:

Jose Mora Friday, May 31, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Jose Mora
Risk-based Design Control - The New Paradigm for Medical Device Design
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. Design control is not only a requirement of the QMS but risk management must be applied to the design control process itself.

John N. Zorich Wednesday, June 5, 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.

Charles H. Paul Monday, June 10, 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.

Wayne Taylor Monday, June 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Wayne Taylor
Validation Sampling Plans for Process Validation, Design Verification and CAPA Effectiveness Checks
This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:

Carolyn Troiano Monday, June 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Carolyn Troiano
21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
The Webinar 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.

Ginette Collazo Monday, June 10, 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 Tuesday, June 11, 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.

Prof. Dr. h.c. Frank Stein Tuesday, June 11, 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.

Edwin Waldbusser Wednesday, June 12, 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.

Casper Uldriks Wednesday, June 12, 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.

David R Dills Wednesday, June 12, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: David R Dills
FDA Issues Final Rule on Symbols in Labeling
The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.

Karl J Hemmerich Thursday, June 13, 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.

John E Lincoln Tuesday, June 18, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: John E Lincoln
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

Susanne Manz Wednesday, June 19, 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.

John N. Zorich Thursday, June 20, 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.

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.

Jose Mora Tuesday, June 25, 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

Edwin Waldbusser Wednesday, June 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Edwin Waldbusser
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This webinar details the regulation and how it applies to computerized systems.

Ginette Collazo Tuesday, June 26, 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.

Charles H. Paul Friday, June 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Charles H. Paul
Project Management for Non-Project Managers
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Carolyn Troiano Friday, June 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
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.

Susanne Manz Tuesday, July 2, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Susanne Manz
Preparing for an FDA Inspection - What you Need to Know
Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively.

Edwin Waldbusser Wednesday, July 10, 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.

Carolyn Troiano Friday, July 12, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Carolyn Troiano
Good Documentation Practices to Support FDA Computer System Validation
As a "GxP"system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.

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.

John E Lincoln Tuesday, July 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: John E Lincoln
Dietary Supplements CGMPS - 21 CFR 111 Compliance
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

John E Lincoln Tuesday, August 6, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: John E Lincoln
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

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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