Webinar Search Results : 94 Upcoming webinars found.
Steven Walfish Thursday, January 10, 2017
11:00 AM PST | 02:00 PM EST
Duration:60 Minutes
Price: $999.00
by: Steven Walfish

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.

Dr. Ludwig Huber Thursday, May 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: $150.00
by: Dr. Ludwig Huber
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations.

Ms. Michael Redmond Friday, May 24, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Ms. Michael Redmond
Are you responsible for Enterprise Risk Management Compliance: How to conduct a Compliance Gap Analysis for ERM, how to get started and what to expect?
This webinar will explain how to conduct a compliance gap analysis for Enterprise Risk Management (ERM). Attendees will learn best practices to ensure ERM compliance.

Susanne Picard Tuesday, May 28, 2019
08:00 AM PDT | 11:00 AM EDT
Duration:60 Minutes
Price: $150.00
by: Susanne Picard
Overcoming Obstacles of the Canadian Drug Regulatory Landscape
Learn what common obstacles are in the Canadian Drug Development and Approval Process and how to avoid them or manage them efficiently should they occur.

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.

Donna K Olheiser Wednesday, May 29, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Donna K Olheiser
Conducting YOUR "NEW 2019" Annual ACH Rules Compliance Audit- a Step-by-Step Guide
The NACHA Operating Rules and Guidelines require that all participating depository financial institutions, third-party senders and third-party service providers that provide ACH services conduct an annual ACH audit to be performed by December 31 of each year (ACH Rules, Article 1).

Miles Hutchinson Wednesday, May 29, 2019
11:00 AM PDT | 02:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Miles Hutchinson
Introduction to Payroll Law
Are you responsible for payroll or employer tax withholding compliance? Or maybe you were recently hired or promoted into the payroll department. During your indoctrination you are surprised at all the interesting things to do and how important this role is to the success of the company.

Dr. Afsaneh Motamed Khorasani Wednesday, May 29, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Dr. Afsaneh Motamed Khorasani
Good Documentation and Record Keeping Best Practices (FDA & EMA)
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

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.

Jonnie T. Keith Wednesday, May 29, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Jonnie T. Keith
Putting the Quality in Audit Reports
How well you communicate that information is critical to getting management's acceptance of your findings and their agreement with your recommendations.

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.

Douglas Cohen Thursday, May 30, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Douglas Cohen
How to Create an Export Compliance Program Under the Export Administration Regulations(EARs)
The US Government regulates the export of information, commodities, technology, and software considered important to US national security, economic competition, and foreign policy.

Robert J. Russell Thursday, May 30, 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.

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:

Carolyn Troiano Friday, May 31, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Carolyn Troiano
3-Hour Virtual Seminar on 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.

Teri C. Soli Friday, May 31, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Teri C. Soli
Water System Biofilm Control and Microbial Monitoring Myths
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Ginette Collazo Friday, May 31, 2019
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.

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.

Dennis Taylor Tuesday, June 4, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Dennis Taylor
Time-Saving Excel Tips, Tricks and 100 Shortcuts
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Gwendolyn Wise-Blackman Wednesday, June 5, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Gwendolyn Wise-Blackman
Implementing a Compliant Stability Program for Biologics
Biologics, as well as small molecule pharmaceutical products, require expiry dating.The complex structure of large molecules presents greater opportunities for degradation. Biologics may lose identity by cleavage ultimately resulting in loss of potency.

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.

Deidre Tate Thursday, June 6, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Deidre Tate
Surviving OSHA Audit in Six Easy Steps
Learn how to quickly spot violations in the workplace and how to correct them to OSHA standards by attending this webinar. The attendee will also be made aware of the most frequent violations, compliance strategies and the defense against citation.

Dennis Taylor Friday, June 7, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:2 Hours
Price: $190.00
by: Dennis Taylor
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

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.

Teri C. Soli Monday, June 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Teri C. Soli
Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

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.

Dr. Afsaneh Motamed Khorasani Monday, June 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Dr. Afsaneh Motamed Khorasani
Good Documentation Guideline (Chapter 1029 USP)
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials).

Ms. Michael Redmond Tuesday, June 11, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Ms. Michael Redmond
Cyber Security Incident Response Team Training Program
Attacker's attack 24x7 and Computer Security Incident Response for a company, government agency or organization must also be ready 24X7. Both reporting incidents and disseminating incident-related information correctly is a must.

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.

John Ryan Tuesday, June 11, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: John Ryan
Responsibilities of the Carrier Under the Final FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods
This is part 1 of a three part required training resulting from the finalization of new US FDA food transportation laws.

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.

Roger Cowan Wednesday, June 12, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: $150.00
by: Roger Cowan
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Michael Esposito Wednesday, June 12, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Michael Esposito
Packaging and Labeling in the Pharmaceutical Supply Chain
Packaging and Labeling form a bridge between the conception of a product and its realization and distribution, and consequently occupy a critical position in the success or failure of any pharmaceutical product launch or revision. Decision-makers need at least a cursory knowledge of potential pitfalls to create contingencies, as it is easier and more cost-effective to change things earlier in process than later.

Mike Thomas Wednesday, June 12, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Mike Thomas
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.

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.

Robert J. Russell Monday, June 17, 2019
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.

Miles Hutchinson Monday, June 17, 2019
11:00 AM PDT | 02:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Miles Hutchinson
How to Analyze Financial Statements
Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales.

David Nettleton Tuesday, June 18, 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).

Robert J. Russell Tuesday, June 18, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Robert J. Russell
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

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.

Dr. Ludwig Huber Tuesday, June 18, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: $150.00
by: Dr. Ludwig Huber
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

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.

Gina Reo Wednesday, June 19, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Gina Reo
New National Bioengineered Food Disclosure Act (GMO Labeling)
This long-awaited new USDA Food Labeling regulation known as the National Bioengineered Food Disclosure Standards Act (NBFDSA) has finally been issued after years of controversy.

Michael Brodsky Thursday, June 20, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Michael Brodsky
ISO-IEC 17025:2017 Section 7 - Process Requirements and Section 8 - Management System Requirements
Many laboratories have successfully developed and implemented a functional quality management system based on the requirements of ISO/IEC 17025:2005.

Gwendolyn Wise-Blackman Thursday, June 20, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Gwendolyn Wise-Blackman
Auditing Laboratories Conducting Assays Supporting Biologics
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.

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.

Joseph P.  ("Joe") McMenamin Friday, June 21, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Joseph P. ("Joe") McMenamin
Legal Issues Raised by Deploying AI in Healthcare
Classically, the law reasons by analogy, and from precedent. The theory is that the law should deal with like situations in like ways.

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

Deidre Tate Tuesday, June 25, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Deidre Tate
Preparing for OSHA Voluntary Protection Program (VPP): Brick by Brick
The OSHA Voluntary Protection Program (VPP) is the highest award in Health and Safety Excellence that OSHA presents to an organization. This training program will guide attendees with best practices in implementing the OSHA VPP program.

Susanne Picard Tuesday, June 25, 2019
08:00 AM PDT | 11:00 AM EDT
Duration:60 Minutes
Price: $150.00
by: Susanne Picard
Demystifying the Canadian Drug and Health Products Regulatory Landscape
In this webinar, we will demystify broadly what the current Canadian regulatory landscape is for efficient Canadian development initiatives.

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.

Ms. Michael Redmond Wednesday, June 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Ms. Michael Redmond
Cyber Security Risk Assessment
An organization's security policy and controls must be adaptable to emerging threats in today's world. The assessment of security threats is ongoing, and must be mapped against the adequacy and existence of security controls. Security controls and countermeasures that are currently in in place may not commensurate with potential risks. The effort is never ending, but knowing how to start is the key.

John Ryan Wednesday, June 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: John Ryan
Carrier Food Safety Problems That May Occur during Transportation (FDA-FSMA)
The FDA recommended course includes actual data, costs and examples from transportation tracked and measured operations.

Dr. Ludwig Huber Wednesday, June 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: $150.00
by: Dr. Ludwig Huber
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Teri C. Soli Thursday, June 27, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Teri C. Soli
Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.

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.

Roger Cowan Friday, June 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Roger Cowan
Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.

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.

Michael Esposito Tuesday, July 2, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Michael Esposito
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.

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.

Gina Reo Tuesday, July 2, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Gina Reo
Developing An Environmental Monitoring Program
Environmental Monitoring is utilized for many reasons in the food industry, but primarily to control pathogens in combination with ones' sanitation program to ensure they are robust. FSMA also requires monitoring or an equivalent program or reasoning if not established for RTE foods.

Mike Thomas Monday, July 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Mike Thomas
Excel Data Visualization - Charts and Infographics
In this session, participants will learn how to visually represent your data using both traditional charts (bar charts, line charts etc.) as well as how to do the same using some of Excel's non-charting tools.

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.

Ms. Michael Redmond Wednesday, July 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Ms. Michael Redmond
Resiliency Individual, Community, Business
Business Continuity Management (BCM) is a holistic management process that identifies potential impacts that threaten an Organization and provides a framework for building resilience with the capability for an effective response that safeguards the interests of its key stakeholders, reputation, brand and value creating activities. This encompasses the management of recovery or continuity in the event of a disaster as well as the management of the overall program through training, rehearsals, and reviews, to ensure the plan stays current and up to date.

John Ryan Thursday, July 11, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: John Ryan
Standardizing Transportation Procedures to Control Food Safety and Quality
The course includes activities to help trainees develop a general plan and procedures to standardize and control food quality and safety transportation processes.

Dr. Ludwig Huber Thursday, July 11, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:2 Hours
Price: $190.00
by: Dr. Ludwig Huber
2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

Deidre Tate Thursday, July 11, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Deidre Tate
OSHA's Final Rule: Worker Exposure to Respirable Crystalline Silica
Exposure to silica has been linked to lung cancer, silicosis, chronic obstructive pulmonary disease, and kidney disease in workers.

Miles Hutchinson Thursday, July 11, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Miles Hutchinson
Introduction to Sales and Use Taxation
This webinar will discuss legal developments in the area of taxation of internet sales

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.

Robert J. Russell Friday, July 12, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Robert J. Russell
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

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.

Gina Reo Wednesday, July 17, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Gina Reo
Guidance for Lubricants in Food Applications
Over application or incorrect usage of lubricants can lead to insanitary conditions or contamination. Often condensate plays a big part in refrigerated foods and mixed with improper use of lubricants can spell potential problems in the environment.

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.

David Nettleton Tuesday, July 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: $150.00
by: David Nettleton
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

Ms. Michael Redmond Tuesday, July 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Ms. Michael Redmond
Designing Full Cyber Security Incident Response Team (CSIRT) Training Program as well as Table Top and Simulation Testing
Attacker's attack 24x7 and Computer Security Incident Response for a company, government agency or organization must also be ready 24X7. Both reporting incidents and disseminating incident-related information correctly is a must.

Dr. Ludwig Huber Thursday, July 25, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: $150.00
by: Dr. Ludwig Huber
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Gina Reo Thursday, August 1, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Gina Reo
Allergen Cleaning, Validation and Preventative Risk Mitigation for FSMA
Allergen mishaps in manufacturing are now a Class I Recall by the FDA (Food & Drug Administration), considered an adulterant in foods.

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.

Gina Reo Tuesday, August 20, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Gina Reo
New Safe Foods For Canadian Regulation
CFIA is moving quickly to automate their compliance systems, tightening timelines for faster recall and crisis handling while enhancing many of their food safety regulations to compete and sync with global players

Gina Reo Thursday, September 5, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Gina Reo
Navigating Prop 65 for the Food Industry
Environmental Monitoring is utilized for many reasons in the food industry, but primarily to control pathogens in combination with ones sanitation program to ensure they are robust.