Webinar Search Results : 33 Upcoming webinars found.
Eleonora Babayants Friday, September 21, 2018
07:00 AM PDT | 10:00 AM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eleonora Babayants
Data Integrity in Compliance with GXP-GMP Regulations
There are GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements.

John E Lincoln Tuesday, September 25, 2018
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, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Ginette Collazo Tuesday, September 25, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Angela Bazigos Wednesday, September 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's Enforcement of 21 CFR Part 11 Compliance
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

John Chapman Thursday, September 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Chapman
Corrective and Preventive Action
This webinar will define and explain Corrective Action and Preventive Action requirements as found in ISO 13485 and FDA requirements.

Edwin Waldbusser Tuesday, October 2, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Edwin Waldbusser
Medical Device Hazard Analysis Following ISO 14971
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools.

John E Lincoln Wednesday, October 3, 2018
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.

John N. Zorich Wednesday, October 3, 2018
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.

Susanne Manz Thursday, October 4, 2018
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.

Carolyn Troiano Friday, October 12, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
FDA's New Draft Guidance on Software and Device Changes and the 510(k)
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.

Eleonora Babayants Friday, October 12, 2018
07:00 AM PDT | 10:00 AM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eleonora Babayants
Change Control Procedures in Regulated Industries
GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. According to these regulations, change control procedures have to be used. Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner.

Wayne Taylor Friday, October 12, 2018
10:00 AM PDT | 01:00 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:

Ginette Collazo Tuesday, October 16, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Ginette Collazo
3-Hour Virtual Seminar on How to Implement an Effective Human Error Investigation Program
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. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Robert J. Russell Tuesday, October 16, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Robert J. Russell
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This 3-hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

John Chapman Thursday, October 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Chapman
Medical Device Complaints, MDRs & Recalls
This webinar will help you to understand complaint handling processes and to reap the benefits of valuable product feedback. The identification of the problem, actual cause of the problem,documentation and regulatory reporting is discussed.Consequences of inadequate investigations are pointed out,including FDA Warning Letters and financial losses.The presentation will also review the regulations and point out some of the pitfalls as well as benefits of complaint handling and reporting.

Eyal Lerner Friday, October 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eyal Lerner
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

Carolyn Troiano Monday, October 22, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
The 21st Century Cures Act - Expediting New Products and New Product Indications
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

John E Lincoln Tuesday, October 23, 2018
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.

Thomas Bento Wednesday, October 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Thomas Bento
Validation of Non-Product Software
This course will teach how to comply to 21 CFR Part 820.70(i) and effectively implement a software validation program for medical devices, meeting the FDA requirements and produce a safe product. We will explain the role of Risk Management in Non-Product Validation. How software requirements are used in validation will be described.

Ginette Collazo Wednesday, October 24, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Susanne Manz Thursday, October 25, 2018
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. You'll learn the essentials of validation planning, protocol writing, and change management

Angela Bazigos Friday, October 26, 2018
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, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).

Marina Malikova Friday, October 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Marina Malikova
Trial Master File Requirements and Essential Regulatory Documents
Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed.

Wayne Taylor Monday, November 5, 2018
10:00 AM PST | 01:00 PM EST
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:

Marina Malikova Tuesday, November 6, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Marina Malikova
ICH GCP Guidelines E6 Revision, R2 Addendum- Changes Impacting Sponsors-CRO-Sites
Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed up clinical development.

Susanne Manz Thursday, November 8, 2018
10:00 AM PST | 01:00 PM EST
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.

Carolyn Troiano Friday, November 9, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries.

Susanne Manz Thursday, November 15, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Risk Management Techniques for Medical Devices
Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

Carolyn Troiano Tuesday, November 27, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar - 21 CFR Part 11 - Guidance for Electronic Records and Electronic Signatures used in FDA-Regulated Computer Systems
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. This includes development of a company philosophy and approach and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

Susanne Manz Thursday, November 29, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Addressing CAPA within a Device Quality System
This webinar will help you ensure an efficient and effective CAPA 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.

Ginette Collazo Thursday, November 29, 2018
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.

Shep Bentley Friday, November 30, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Shep Bentley
3-Hour Virtual Seminar on Medical Device Single Audit Program (MDSAP) Preparation
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

Carolyn Troiano Friday, December 7, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar - Best Practices to Help you Pass an FDA Computer System Validation Audit
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 help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.

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