Webinar Search Results : 65 Upcoming webinars found.
Susanne Manz Friday, October 18, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Susanne Manz
Quality Management System - Structure and Development
This webinar will help you to develop a Quality Management System (QMS) for Medical Device Companies. A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient.

Carolyn Troiano Friday, October 18, 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.

Ginette Collazo Friday, October 18, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Ginette Collazo
3-Hour Virtual Seminar on Human Error Reduction in GMP Related Environments
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.

Angela Bazigos Friday, October 18, 2019
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 uses the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the predictability, consistency, and transparency of the "when to submit" decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.

Susanne Manz Monday, October 21, 2019
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.

Peggy Berry Tuesday, October 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Peggy Berry
Raw Materials in Pharma-Biotech Production
This program will address approaches to selecting primary and secondary suppliers of raw materials, developing an incoming receipt and testing process, adequate and appropriate storage, and other considerations for the raw materials used in drug product processing.

John Ryan Tuesday, October 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: John Ryan
Traceability and Recall Through Food Processes
This webinar will cover traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls. The session will also cover associated information like identification, classification and protocols.At the end of this webinar, the speaker will handle your specific questions related to the topic.

Allecia Harley Tuesday, October 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Allecia Harley
Why Silos are not the Real Problem: Using Warm Hand-offs
Breaking down silos by cross-training employees that have spent years developing expertise in their roles decreases efficiency, job satisfaction, and autonomy.

Steve Gompertz Tuesday, October 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Steve Gompertz
The 7 Habits of Highly Effective Project Managers
Too often Project Leaders and Managers fall into the role due to demonstrated technical competence. After all, if you're competent enough to create great technical output, certainly you can figure out how to run a project on schedule and within budget, right? And even when you get an opportunity to attend training to become a better Project Manager, the focus is on the "hard" or technical aspects of project management rather than the "soft" skills or habits that typically only come with experience.

Swasita Saigal Tuesday, October 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Swasita Saigal
Managing Complaints, Small Business Perspective
This webinar will review GMP requirements for complaint handling. We will also discuss the types of complaints (adverse and non-adverse events) that may be received.

Martin K. Behr, III Wednesday, October 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Martin K. Behr, III
The Foreign Corrupt Practices Act: What Every U.S. Businessperson Must Know
The FCPA makes it unlawful for any U.S. citizen or firm (or any person who acts on behalf of a U.S. citizen or firm) to use a means of U.S. interstate commerce to offer, pay, transfer, or authorize a payment, transfer, or promise of money or anything of value to any foreign appointed or elected official, foreign political candidate, or candidate for a foreign political office for a corrupt purpose.

John N. Zorich Wednesday, October 23, 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.

Angela Bazigos Thursday, October 24, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Bootcamp on How the FDA are Trained for Medical Device Inspections
This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms. It will present the specific guidance FDA inspectors receive for each of the regulations.

Edwin Waldbusser Thursday, October 24, 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.

Carolyn Troiano Thursday, October 24, 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.

Ginette Collazo Friday, October 25, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Ginette Collazo
Supervising a Human Error Free Environment: You can do a Lot More than you Think
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Angela Bazigos Friday, October 25, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Data Without Integrity is Just Numbers
We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:

Deidre Tate Friday, October 25, 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.

Dennis Taylor Monday, October 28, 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:

Joy McElroy Monday, October 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Joy McElroy
GLPs: How are they Associated with GMPs and SOPs
Good Laboratory Practices (GLPs), CFR part 58 is a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

Casper Uldriks Tuesday, October 29, 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.

Joy McElroy Tuesday, October 29, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Joy McElroy
Writing Validation Master Plans; Best Practices for Writing a Compliant Document
This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs.

Susanne Manz Wednesday, October 30, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Susanne Manz
Secrets to Writing Effective SOPs for Medical Device QMS
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

Angela Bazigos Wednesday, October 30, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions
The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.

Willy Vandenbrande Wednesday, October 30, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Willy Vandenbrande
The Future of Quality Tools
Several trends will influence business. For this presentation we are looking at three specific ones, and their impact on quality management and quality tools. The first trend is digitization, not just of business processes but also of society at large.

Michael Esposito Thursday, October 31, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:2 Hours
Price: $190.00
by: Michael Esposito
2-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations.

Ginette Collazo Friday, November 1, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Ginette Collazo
3-Hour Virtual Seminar on Human Error Reduction in the Manufacturing Floor
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.

Angela Bazigos Friday, November 1, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information you will be able to develop meaningful CAPAs that have a chance to remedy these problems, the first time.

Peggy Berry Monday, November 4, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Peggy Berry
Comparability Protocols for Approved Drugs
This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission.

David Nettleton Monday, November 4, 2019
10:00 AM PST | 01:00 PM EST
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.

Willy Vandenbrande Tuesday, November 5, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: $150.00
by: Willy Vandenbrande
Quality 4.0: Managing Disruptive Change
The feeling is sometimes created that technology itself leads the waves of change. As a consequence, companies look at their IT department thinking that digitization will make the company better and more competitive. But the key to success is to use the right technology at the right time and in the right way.

Casper Uldriks Tuesday, November 5, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: $290.00
by: Casper Uldriks
3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

Ginette Collazo Tuesday, November 5, 2019
10:00 AM PST | 01:00 PM EST
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.

Martin K. Behr, III Wednesday, November 6, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Martin K. Behr, III
3-Hour Virtual Seminar on The "New NAFTA": The USMCA
The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes.

Carolyn Troiano Wednesday, November 6, 2019
10:00 AM PST | 01:00 PM EST
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.

Allecia Harley Thursday, November 7, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: $150.00
by: Allecia Harley
Does Having a Clinical Trial Management System Actually Decrease Study Start-Up Times?
Clinical Trial Management Systems have been sold as the answer to a number of challenges:

David Nettleton Thursday, November 7, 2019
10:00 AM PST | 01:00 PM EST
Duration:2 Hours
Price: $190.00
by: David Nettleton
2-Hour Virtual Seminar on The 6 Most Common Problems in FDA Software Validation and Verification
This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

Ginette Collazo Thursday, November 7, 2019
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.

Deidre Tate Thursday, November 7, 2019
10:00 AM PST | 01:00 PM EST
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.

John N. Zorich Friday, November 8, 2019
10:00 AM PST | 01:00 PM EST
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.

Gwendolyn Wise-Blackman Monday, November 11, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: $290.00
by: Gwendolyn Wise-Blackman
3-Hour Virtual Seminar on Bioanalytical Method Validation
The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics. These methods include analytical procedures that test for identity, purity, potency, and stability of drug substances and drug products.

John E Lincoln Tuesday, November 12, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: $150.00
by: John E Lincoln
Project Management for FDA-Regulated Companies
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.

John Ryan Wednesday, November 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: $150.00
by: John Ryan
Poultry's Role in Food Security and Sustainability
Poultry is big business. Rarely a month goes by without some sort of poultry food safety recall.

John N. Zorich Wednesday, November 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:2 Hours
Price: $190.00
by: John N. Zorich
2-Hour Virtual Seminar on 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.

Nancy Knettell Wednesday, November 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: $150.00
by: Nancy Knettell
Is your Software 510k Ready
This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510(k) approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510(k) has been denied because the software portion of the submission is inadequate and not compliant.

John E Lincoln Wednesday, November 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: $150.00
by: John E Lincoln
Root Cause Analysis - Starting at the Beginning
CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

William D Fox Friday, November 15, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: William D Fox
GxP Quality Management System (QMS): Moving from Compliance to Quality
There are those of us who think that the psychology of man, each and together, has more impact on markets, business, services, construction, and the entire fabric of an economy than all the more measurable statistical indices.- Malcom S. Forbes.

Angela Bazigos Friday, November 15, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
Part 11 / Annex 11 Computer Systems Validation (CSV) is to be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance.

Steven Wachs Monday, November 18, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: $150.00
by: Steven Wachs
Determining Sample Size: What Sample Size Should I Use?
The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.

Carolyn Troiano Monday, November 18, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Carolyn Troiano
FDA's New Draft Guidance on Software and Device Changes and the 510(k)
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.

Willy Vandenbrande Tuesday, November 19, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Willy Vandenbrande
Quality for a Sustainable Future
As an introduction we point out how important sustainability is for the planet as a whole and how companies will be faced with increasing demands on their impact on society, in all aspects of the term. We also give a brief overview of how sustainability has been wrongly tackled in the past.

John Ryan Wednesday, November 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: $150.00
by: John Ryan
Food Waste Reduction: The Road to Cost Reductions and Sustainability
Food waste is a well-recognized issue throughout the food supply chain. Loss estimates run anywhere from 30% to 50%. Water, fertilizer, manpower, facility overhead costs, delivery/planting/production/storage and delivery, carbon emissions, environmental pollution and other food production expenses are lost along with the food that cannot be consumed.

Angela Bazigos Wednesday, November 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Export Certificate for Medical Devices - Edge Out your Competition!
In today's global environment, sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the issues involved in managing regulations across different countries.

Angela Bazigos Thursday, November 21, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements
Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents.

Ginette Collazo Friday, November 22, 2019
10:00 AM PST | 01:00 PM EST
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.

Nancy Knettell Monday, November 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: $150.00
by: Nancy Knettell
Medical Device Software Verification Validation
This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510(k) regulatory approval. One of the biggest risks most company's face when submitting their device for approval is finding out after as many as seven or more months post filing that the 510(k) has been denied because the software portion of the submission is inadequate and not compliant.

John Ryan Tuesday, November 26, 2019
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: $150.00
by: John Ryan
Environmental Contamination of Ready-to-Eat (RTE) Foods and the Role of the Environment and Water
One of the three most critical food safety issues facing the food industry today is environmental contamination of ready-to-eat foods (RTEs). Ready-to-eat foods have no kill step applied between the sale of the product and consumption by consumers. Demand for such product is drastically increasing as consumers look for increasing levels of convenience.

Gwendolyn Wise-Blackman Wednesday, November 27, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: $150.00
by: Gwendolyn Wise-Blackman
Implementing Process Controls for Cell-Based Assays
Bioassays are used to demonstrate that a biologic product performs per the stated function and potency. Typically, these methods are performed in living systems. Cell-based methods can have inherent variability due to the nature of living systems.

William D Fox Tuesday, December 3, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: William D Fox
The GxP Audit Report and The Savannah Brain
"It's not what you say but how you say it." - Every Parent The written audit report is arguably the most important phase of an audit. It serves as a record of GxP compliance, a list of risk appraised audit findings and a value adding tool which actuates assessment, relates assurance and promotes action.

Angela Bazigos Tuesday, December 3, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
21 CFR 11 Compliance for Excel Spreadsheets
Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance.

David Nettleton Wednesday, December 4, 2019
10:00 AM PST | 01:00 PM EST
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).

Nancy Knettell Wednesday, December 4, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: $150.00
by: Nancy Knettell
Software As a Medical Device (SaMD) New IVDR Document Requirements
This course is essential for IVD Medical Device companies interested in ensuring their software enabled medical Devices or Software as an IVD Medical Device is compliant to the new Software requirements in the IVDR 2022 regulations avoiding revenue interruptions that can result from failed unannounced audits.

Angela Bazigos Friday, December 6, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information you will be able to develop meaningful CAPAs that have a chance to remedy these problems, the first time.

Nancy Knettell Wednesday, December 11, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Nancy Knettell
EN/IEC 62304 - Is your Medical Device Software Out of Compliance
This course is essential for Medical Device and IVD companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval.

Angela Bazigos Wednesday, December 11, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
FDA's 21 CFR Part 11 Add-on Inspections
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. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003.

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