Webinar Search Results : 42 Upcoming webinars found.
Laura Brown Friday, May 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
CAPA Systems for Compliance
This course will be ideal for you to learn how to improve industry procedures and processes and how to implement and document an effective CAPA quality system.

Angela Bazigos Friday, May 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3 Hours Boot Camp on Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds
This presentation uses the latest FDA thinking and guidance documents to assist you in re-establishing those requirements that need to be fulfilled in the evaluation for microbial methods used in your testing laboratories. It also re-establishes performance evaluation (verification & validation) criteria, necessary for the use of commercially-available diagnostic test kits and platforms.

Ginette Collazo Wednesday, May 23, 2018
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.

Shep Bentley Friday, May 25, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Shep Bentley
FDA Review of 510(k)s - How to Speed the Process
Every person or company who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).

Susanne Manz Wednesday, May 30, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 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.

Angela Bazigos Tuesday, June 5, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Off label Promotion of Drugs and Medical Devices - FDA's Latest
Off Label Promotion for Drugs and Medical Devices is a controversial topic which often puts FDA and industry at loggerheads. FDA continues to need to ensure public health by protect public health by ensuring that medical products distributed in the United States are safe and effective for their intended use while industry believes that safe and effective off label use is warranted. It is further complicated by today's patient who is much more savvy with regards to treatment and sometimes demands off-label use of products.

Robert Michalik Wednesday, June 6, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Robert Michalik
Advanced Legal Writing Methodologies for Successful FDA 'Breakthrough Therapy' Submissions
The scientific and regulatory landscapes continue to evolve as novel breakthrough therapies are envisioned and developed in R&D labs around the world. Gene editing via CRISPR and nuclease enzymes such as Cas9, Cpf1 or C2c1, PAM-dependent target recognition, and gene delivery approaches such as adeno associated virus (AAV) are dominating the news today.

John N. Zorich Wednesday, June 6, 2018
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.

Larry Spears Wednesday, June 6, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Larry Spears
FDA Export Certificates for Medical Devices
Companies need to stay internationally competitive and this webinar on export certificates provides a key link for entry to markets around the globe. This webinar will explore the export approval and certification process in the U.S. It will include guidance on preparing applications and obtaining FDA's certification that specific products identified for export meet U.S. regulatory requirements. All of this will be valuable in obtaining broader access to global markets.

Eleonora Babayants Thursday, June 7, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eleonora Babayants
Corrective and Preventive Action (CAPA) per FDA Requirements
CAPA - Corrective and Preventive Action plan. CAPA is a concept within Good Manufacturing Practice (GMP). It is required for FDA compliance in case of specification situations or other deviations. CAPA is part of the overall quality management system (QMS).

Shep Bentley Friday, June 8, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Shep Bentley
Risk Management Simplified
At its most basic, risk management is the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk. The International Standards Organization (ISO) Technical Committee 210 (ISO/TC 210), Quality management and corresponding general aspects for medical devices, was formed in 1994, and the group published the first edition of the ISO 14971 risk management standard for medical devices in 1998.

Grace Morgan Holmes Monday, June 11, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Grace Morgan Holmes
Developing and Implementing Effective Corrective Action Plans in Clinical Trials
The concept of corrective and preventative actions (CAPA) are generally intertwined with the process of ensuring product quality in Good Manufacturing Procedures (GMP)- compliant manufacturing settings. This is because CAPA has been predominantly used to address identified errors and issues per regulatory requirements within the confines of current GMP (cGMP).

David Dills Monday, June 11, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: David Dills
Complaint Handling and Management: From Receipt to Trending
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Ginette Collazo Tuesday, June 12, 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.

Jack Dhuwalia Tuesday, June 12, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jack Dhuwalia
Verification vs. Validation in Regulated Industries for Processes
Various regulations for Medical Devices as well as Combination Products require aspects of design control to include these steps. Verification generally addresses whether the device meets its design -basically an internal review whereas Validation evaluates how well the entire system perform when subjected to real-world conditions such as in an operating room -does it work as intended?

Susanne Manz Tuesday, June 12, 2018
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.

Jose Mora Wednesday, June 13, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
Through the Eyes of an Auditor
Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally, an auditor has personal experiences of what a state of control looks like and has visited sufficient places to know what to look for.

David Dills Wednesday, June 13, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: David 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.

Edwin Waldbusser Thursday, June 14, 2018
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, June 14, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Responding to FDA 483s and FDA Warning Letters
Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.

Casper Uldriks Tuesday, June 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
FDA's New Import Program for 2018
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.

John N. Zorich Wednesday, June 20, 2018
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.

Christina Bernstein Wednesday, June 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Christina Bernstein
Medical Devices: Hazard Identification and Risk Assignment Using Public Data Sources
There is no universal standard for assigning risk to a medical device, and competing manufacturers of devices may quantify risk differently for similar identified hazards. One manufacturer may identify a hazard as a high enough risk to warrant triggering an alarm, and their competitor may decide that same hazard is not such a high risk and just note it as a "feature" for the label. We will together construct a simple example of a risk table using known standards, guidelines, regulations, and public data.

Jose Mora Wednesday, June 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
Chipping Away at Constraints - Practical Tips to Improve your Manufacturing Operations
Many times your manufacturing operation seems very busy yet the throughput of the entire line is poor.We often confuse busy and efficient with productive. This webinar is based upon real-life examples and how simple techniques were used to improve overall productivity without the need to spend weeks performing complex modeling and analysis.

Salma Michor Thursday, June 21, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Salma Michor
The New EU Medical Device Regulation
Regulation proposals of the European Commission

Angela Bazigos Thursday, June 21, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3 hour Virtual Seminar On Medical Device Recalls: How to Properly, Compliantly, and Promptly Deal with a Recall
Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from devices that present a risk of injury or gross deception or are otherwise defective.

Eyal Lerner Friday, June 22, 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).

Lena Cordie Friday, June 22, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lena Cordie
Software Verification & Validation
Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood.

David Dills Tuesday, June 26, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: David Dills
3-Hour Virtual Seminar on Complaint Handling and Management: From Receipt to Trending
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Susanne Manz Thursday, June 28, 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.

Robert Michalik Thursday, June 28, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Robert Michalik
Chemistry 101 for Medical Device Regulatory & Quality Professionals: Essential knowledge needed to Manage Drug&Device Combination Product Project
Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect.

Carolyn Troiano Friday, June 29, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
FDA Compliance and Mobile Applications
This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to FDA and/or must be available for FDA review upon inspection or audit. Mobile applications may be used in any area of an FDA-regulated company. Functional areas where FDA-regulated data is typically processed include, but are not limited to Quality Laboratories, Manufacturing, Supply Chain/Distribution, Adverse Event Reporting, Post-Marketing Surveillance. Systems may also be used to monitor and/or control FDA-regulated processes and equipment, handle product labeling, product lot control, clinical trial and trial sample management, and many other processes.

Angela Bazigos Wednesday, July 11, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Deal with the Contradictions and Challenges of Using Cloud in a Regulated Environment
This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

Salma Michor Thursday, July 12, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Salma Michor
Combination Products Registration
During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.

Jose Mora Tuesday, July 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
Process Validation Requirements & Compliance Strategies
This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.

Susanne Manz Wednesday, July 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Non-Conforming Material and Failure Investigation
Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.

Jose Mora Thursday, July 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
Effective Design of Experiments (DOE) Strategies
This DOE (Design of experiments) training focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.

Casper Uldriks Tuesday, August 28, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
FDA's Revolutionary Change in Software Regulation
Congress recognized that FDA struggles with software regulation. So, Congress removed some software out of FDA's jurisdiction. Now FDA must revise its premarket and postmarket software regulatory approach, including mobile apps. Using voluntary standards in premarket submissions can be used more effectively. Even more dramatic, FDA's new Digital Health initiative turns FDA's premarket clearance program on its head.

Ginette Collazo Thursday, August 30, 2018
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.

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.

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.

Ginette Collazo Thursday, November 29, 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.

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