• 3
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Successfully Dealing with Difficult People: The 5 Most Difficult Types of People and How to Effectively Approach them

your work group and your company as a whole can be the catalyst that motivates your teams to heightened productivity. Utilizing extensive practice in the principles of emotional intelligence, Successfully Managing People underscores the importance of self-awareness in developing sensitivity to and better communication with others. You'll leave this 90 Minutes webseminar well versed in the most effective methods for dealing with difficult people winning cooperation and trust and ensuring that your people's values and your organization's goals are in sync.

Chris Devany Chris Devany | Duration:90 Minutes | Price: $145.00 | View Details
  • 3
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Learn to Sort, Prioritize and Get Work done Right in your Inbox

Prioritizing is a fundamental time management principle and, in this webinar, you are taught the principles of prioritizing and how to work check off work right in your Inbox.

Steven Walfish Steven Walfish | Duration:60 Minutes | Price: $145.00 | View Details
  • 3
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Stay Interviews: A Powerful and Low-Cost Employee Engagement and Retention Tool

The best way to find out what your employees want and how to retain them is to ask them. Ask questions to gauge how you're meeting your employees' expectations. Not just "How's it going?", but specific questions to get specific answers. Explore why these people remain with your company. Why did they join the organization? How well are their objectives or dreams being fulfilled? Which aspects of their work do they enjoy the most? Which do they least enjoy? Are they receiving sufficient opportunities for growth and development? What would influence them to look elsewhere?

Steven Walfish Steven Walfish | Duration:60 Minutes | Price: $145.00 | View Details
  • 3
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

A Remote Workplace Can Be a Beautiful Environment

Obviously there is a tidal wave force driving the work at home concept right now in our society with the global outbreak of Corona virus.

Steven Walfish Steven Walfish | Duration:60 Minutes | Price: $145.00 | View Details
  • 3
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

No - Panic Presentation Skills for Executives

This webinar highlights best practices for executives and industry leaders who want to speak up and stand out in both formal and informal settings.

Steven Walfish Steven Walfish | Duration:60 Minutes | Price: $145.00 | View Details
  • 6
  • April
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

HR Metrics: A Critical Measurement of the Impact of Human Resources Management

Effective HR metrics are not developed in a vacuum. The "right or best" metrics require a detailed understanding of your organization: how it generates revenue, its business strategies and objectives, it business imperatives, the risks it faces, the opportunities to be seized, and what it already measures.

Ronald Adler Ronald Adler | Duration:90 Minutes | Price: $145.00 | View Details
  • 6
  • April
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Best Practices for Implementing Employee Engagement Surveys

Improving employee engagement can have dramatic effects on the organization's bottom line. Engaged employees are significantly more productive and less likely to leave.

Dr. B. Lynn Ware Dr. B. Lynn Ware | Duration:60 Minutes | Price: $145.00 | View Details
  • 6
  • April
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Medical Marijuana and CBD in the Workplace: Challenges for HR and Management

Marijuana laws are evolving across the United States. Some state laws are legalizing medical marijuana only, while other states recognize marijuana as a legal recreational drug along with alcohol.

Steven Walfish Steven Walfish | Duration:75 Minutes | Price: $145.00 | View Details
  • 7
  • April
  • 2020
  • Tuesday
12:00 PM PDT | 03:00 PM EDT

Successfully Manage Employees who Work from Home

Though there has been a recent trend toward employers offering remote working and telecommuting arrangements, having a majority of your workforce working from home can be daunting when leaders and managers have firm deliverables and deadlines to meet.

Dr. B. Lynn Ware Dr. B. Lynn Ware | Duration:60 Minutes | Price: $145.00 | View Details
  • 7
  • April
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Managing a Remote Workforce Through the Coronavirus Pandemic

The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.

Brenda Neckvatal Brenda Neckvatal | Duration:90 Minutes | Price: $145.00 | View Details
  • 7
  • April
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Change Management System

The presentation will focus on FDA responses to failures in Change Management.

Courtland Imel Courtland Imel | Duration:60 Minutes | Price: $150.00 | View Details
  • 7
  • April
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.

Angela Bazigos Angela Bazigos | Duration:90 Minutes | Price: $150.00 | View Details
  • 8
  • April
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration:90 Minutes | Price: $150.00 | View Details
  • 8
  • April
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Validation of HPLC/UPLC Methodologies

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

John C. Fetzer John C. Fetzer | Duration:60 Minutes | Price: $150.00 | View Details
  • 8
  • April
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Handling OOS Test Results and Completing Robust Investigations

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.

Danielle DeLucy Danielle DeLucy | Duration:90 Minutes | Price: $150.00 | View Details
  • 9
  • April
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

COVID-19 - Working Remotely for Business Continuity

Do you need to work from home due to the Covid-19 virus or other "unexpected" reasons? Working remotely sounds like a dream, but it can be a nightmare for not only you, but everyone on your team.

Rhonda Scharf CSP - HoF Rhonda Scharf CSP - HoF | Duration:60 Minutes | Price: $145.00 | View Details
  • 9
  • April
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

How to write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

Ginette Collazo Ginette Collazo | Duration:90 Minutes | Price: $150.00 | View Details
  • 10
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Corona Virus-19 Impact on FDA Imports

FDA import operations have changed. Some will be temporary and some will be permanent.

Casper Uldriks Casper Uldriks | Duration:60 Minutes | Price: $150.00 | View Details
  • 10
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Implementing an Effective CAPA System

CAPA, no matter how you look at it, is the heart of the quality management system. CAPA can be viewed as and is the merging of change control, continuous improvement, and complaint management.

Charles H. Paul Charles H. Paul | Duration:60 Minutes | Price: $150.00 | View Details
  • 10
  • April
  • 2020
  • Friday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on Introduction to Design of Experiments

In this training program, attendees will understand when and why to apply DOE (design of experiments).

Steven Wachs Steven Wachs | Duration:3 Hours | Price: $290.00 | View Details
  • 10
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 13
  • April
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

FDA's Problem with Software Monsters

Software's level of complexity and use keeps expanding at exponential levels. Likewise, the potential risks to health and loss of privacy follow suit.

Casper Uldriks Casper Uldriks | Duration:60 Minutes | Price: $150.00 | View Details
  • 14
  • April
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

Angela Bazigos Angela Bazigos | Duration:90 Minutes | Price: $150.00 | View Details
  • 15
  • April
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

David Nettleton David Nettleton | Duration:2 Hours | Price: $190.00 | View Details
  • 15
  • April
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Are You Ready for FDA FSMA Preventive Controls Audit?

This course will examine new FDA authority, introduces examples of Preventative Controls, leading into minimal recommended preparation steps for handling the new FDA FSMA requirements, including managing Form #483, or the FDA Warning for non-compliances.

Gina Reo Gina Reo | Duration:60 Minutes | Price: $150.00 | View Details
  • 15
  • April
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Elections in the Shadow of Coronavirus Threat - 2020 Elections Day in Israel

The current outbreak of coronavirus disease (COVID-19) that was first reported from Wuhan, China, on 31 December 2019 is overwhelming the world.

Yuval Shapiro Yuval Shapiro | Duration:60 Minutes | Price: $150.00 | View Details
  • 16
  • April
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Good Documentation Practice (GDocP) for FDA Regulated Industries

GxP/GMP and Good Documentation Practice (GDocP) are the standards in the regulated industries by which documents are created and maintained. Because GDocP is aligned with GxP/GMP, documentation is a critical tool for ensuring GxP/GMP compliance.

Eleonora Babayants Eleonora Babayants | Duration:90 Minutes | Price: $150.00 | View Details
  • 17
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Data Security in the Current Pandemic of Coronavirus

Data security is the high priority in any organization but especially in regulated industries.Companies need to safeguard against every possible vulnerability across their entire infrastructure.

Eleonora Babayants Eleonora Babayants | Duration:60 Minutes | Price: $150.00 | View Details
  • 17
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Management System Auditing: How to Prepare for a Process Audit

Process auditing is a critical part of maintaining any management system.

Mark Hammar Mark Hammar | Duration:60 Minutes | Price: $150.00 | View Details
  • 17
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Deidre Tate Deidre Tate | Duration:90 Minutes | Price: $150.00 | View Details
  • 20
  • April
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Root Cause Analysis for CAPA

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 21
  • April
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on FDA's section 804 Drug and 801(d)(1)(B) Biologic Importation Programs

This presentation outlines the two proposed pathways through which HHS and FDA will allow for the importation of certain drugs originally intended for non-US markets.

Angela Bazigos Angela Bazigos | Duration:3 Hours | Price: $290.00 | View Details
  • 21
  • April
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Trump's Tariff's: Sections 201, 232, and 301: What Every Importer and Exporter must Know

The President's recent tariff actions raise a number of significant issues for Congress.

Martin K. Behr, III Martin K. Behr, III | Duration:90 Minutes | Price: $150.00 | View Details
  • 22
  • April
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Casper Uldriks Casper Uldriks | Duration:60 Minutes | Price: $150.00 | View Details
  • 22
  • April
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Validation of GC / GC-MS Methodologies

This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS).

John C. Fetzer John C. Fetzer | Duration:60 Minutes | Price: $150.00 | View Details
  • 22
  • April
  • 2020
  • Wednesday
12:00 PM PDT | 03:00 PM EDT

The Credit Manager's Tool Box - Tools And Techniques For Making Sound Credit Decisions

This webinar will provide guidance on how gather information, evaluate it, and make sound credit decisions on prospective clients and existing borrowers.

Dev Strischek Dev Strischek | Duration:60 Minutes | Price: $150.00 | View Details
  • 23
  • April
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Crisis Response and Preparedness - Documentation, IT systems, Data Integrity in the current Pandemic of Coronavirus

Data integrity, data security, and crisis preparedness are high priorities in any organization but especially in regulated industries.

Eleonora Babayants Eleonora Babayants | Duration:60 Minutes | Price: $150.00 | View Details
  • 23
  • April
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

GMP Expectations for Products Used in Early Phase IND Studies

FDA issued a guidance document covering GMP requirements for Phase 1 products.

Steven S. Kuwahara Steven S. Kuwahara | Duration:90 Minutes | Price: $150.00 | View Details
  • 23
  • April
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Best Practices for Deviation Investigations

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.

Danielle DeLucy Danielle DeLucy | Duration:60 Minutes | Price: $150.00 | View Details
  • 24
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Sample Size Determination for Design Validation Activities

Design Validation should ensure that product performance, quality, and reliability requirements are met.

Steven Wachs Steven Wachs | Duration:90 Minutes | Price: $150.00 | View Details
  • 24
  • April
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

What to Expect with the new FSMA Intentional Adulteration Regulation

IA establishes requirements to prevent or significantly minimize acts intended to cause wide-scale public health harm.

Gina Reo Gina Reo | Duration:60 Minutes | Price: $150.00 | View Details
  • 27
  • April
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Creating Optimal Sampling Plans

A sampling plan is a term widely used in research studies that provide an outline on the basis which of research is conducted.

Yuval Shapiro Yuval Shapiro | Duration:60 Minutes | Price: $150.00 | View Details
  • 29
  • April
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Create Income you Will Never Outlive: How to Never Lose a Dollar in Stock Market Loss

Life and money are inextricably linked, whether you like it or not. Whenever you're about to embark on a new chapter in your life, it's crucial to have your financial affairs in order.

Kris Miller Kris Miller | Duration:60 Minutes | Price: $150.00 | View Details
  • 29
  • April
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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 E Lincoln John E Lincoln | Duration:60 Minutes | Price: $150.00 | View Details
  • 29
  • April
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Zero-Injury Workplace Culture vs. Safety Culture

Explain what it means to have a 'zero incident workplace culture'on site. Identify the 4 phases of the safety maturity curve process.

Deidre Tate Deidre Tate | Duration:60 Minutes | Price: $150.00 | View Details
  • 29
  • April
  • 2020
  • Wednesday
12:00 PM PDT | 03:00 PM EDT

Cash Flow Analysis Of Borrower's Repayment Ability

There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits." But it is not just cash flow; it is cash flow from operations that is the most desirable source of repayment because it is generated by a borrower managing its working capital assets and earning a sustainable profit.

Dev Strischek Dev Strischek | Duration:60 Minutes | Price: $150.00 | View Details
  • 30
  • April
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Writing and Managing Compliance Documents for Success

This webinar will describe GxP/GMP requirements for documentation and the purpose of compliance documents.

Eleonora Babayants Eleonora Babayants | Duration:90 Minutes | Price: $150.00 | View Details
  • 30
  • April
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Make Your FDA Inspection as Painless as Possible

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.

Angela Bazigos Angela Bazigos | Duration:90 Minutes | Price: $150.00 | View Details
  • 30
  • April
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

John N. Zorich John N. Zorich | Duration:60 Minutes | Price: $150.00 | View Details
  • 5
  • May
  • 2020
  • Tuesday
12:00 PM PDT | 03:00 PM EDT

The Income Statement - What a Banker Can Learn About a Borrower from Its Profit and Loss Statement

This program is designed to show bankers, lenders and credit professionals:

Dev Strischek Dev Strischek | Duration:60 Minutes | Price: $150.00 | View Details
  • 6
  • May
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

David Nettleton David Nettleton | Duration:75 Minutes | Price: $150.00 | View Details
  • 6
  • May
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Production and Process Controls for Medical Device Companies

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce safe and effective products.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 7
  • May
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Batch Record Review and Product Release

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

Danielle DeLucy Danielle DeLucy | Duration:60 Minutes | Price: $150.00 | View Details
  • 7
  • May
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Spill Prevention Control and Countermeasures (SPCC) Inspection Requirements

The SPCC rule requires that you:

Robert A. (Bob) LaRosa Robert A. (Bob) LaRosa | Duration:60 Minutes | Price: $150.00 | View Details
  • 7
  • May
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

John N. Zorich John N. Zorich | Duration:90 Minutes | Price: $150.00 | View Details
  • 8
  • May
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

ISO 22000:2018 Explained in 25 Diagrams

This webinar-based on the e-book of the same name-is more than a list of what has changed, is a new way to look at ISO 22000.

Angela Bazigos Angela Bazigos | Duration:90 Minutes | Price: $150.00 | View Details
  • 11
  • May
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

Myth and Reality of FDA Inspection. FDA Inspection Process Overview and Practical Guidelines

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.

Angela Bazigos Angela Bazigos | Duration:90 Minutes | Price: $150.00 | View Details
  • 12
  • May
  • 2020
  • Tuesday
09:00 AM PDT | 12:00 PM EDT

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

John E Lincoln John E Lincoln | Duration:90 Minutes | Price: $150.00 | View Details
  • 13
  • May
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

Attend this webinar to learn how to understand control charts and their underlying statistics, how to choose variables to monitor, how to maintain the records and to plan adjustments.

John C. Fetzer John C. Fetzer | Duration:60 Minutes | Price: $150.00 | View Details
  • 14
  • May
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

FDA Compliance for Mobile Applications

The workspace is becoming increasingly mobile. Mobile computing enables access from anywhere. Employees and customers expect and demand that all business applications support mobility.

Eleonora Babayants Eleonora Babayants | Duration:60 Minutes | Price: $150.00 | View Details
  • 14
  • May
  • 2020
  • Thursday
12:00 PM PDT | 03:00 PM EDT

Key Elements in Managing and Maintaining Your Credit Administration and Credit Policy

This session by Dev Strischek is intended to provide guidance on how to develop and maintain a Credit Administration (CA) function that will provide guidance to anyone involved in the credit function of the bank.

Dev Strischek Dev Strischek | Duration:60 Minutes | Price: $150.00 | View Details
  • 15
  • May
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

ISO 45001: What is Emergency Preparedness and Response?

With any occupational health & safety management system (OHSMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.

Mark Hammar Mark Hammar | Duration:60 Minutes | Price: $150.00 | View Details
  • 18
  • May
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Supplier Auditing for Medical Device Companies

This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 18
  • May
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Laboratory Safety Requirements

The Occupational Exposure to Hazardous Chemicals in Laboratories standard (29 CFR 1910.1450), commonly referred to as the Laboratory standard, requires that the employer designate a Chemical Hygiene Officer and have a written Chemical Hygiene Plan (CHP), and actively verify that it remains effective.

Robert A. (Bob) LaRosa Robert A. (Bob) LaRosa | Duration:60 Minutes | Price: $150.00 | View Details
  • 19
  • May
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar Project Management for Computer Systems Validation

Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion.

Angela Bazigos Angela Bazigos | Duration:3 Hours | Price: $290.00 | View Details
  • 19
  • May
  • 2020
  • Tuesday
12:00 PM PDT | 03:00 PM EDT

C for Yourself: The 5 C's of Credit

The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.

Dev Strischek Dev Strischek | Duration:60 Minutes | Price: $150.00 | View Details
  • 20
  • May
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Danielle DeLucy Danielle DeLucy | Duration:60 Minutes | Price: $150.00 | View Details
  • 26
  • May
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Labelling for Prescription Drugs, Biologics and Combination Products

In 2019, FDA issued two guidance documents on labeling of prescription drugs, biologics and combination products. Their purpose is to make this process of labeling clearer and more helpful for patients.

Eleonora Babayants Eleonora Babayants | Duration:60 Minutes | Price: $150.00 | View Details
  • 26
  • May
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Issues in Calibrations and Accuracy in Method Validation

This webinar will cover validation of calibrations and the strengths, weaknesses, and appropriateness of the different types of standards. Without accuracy, a result is not acceptable.

John C. Fetzer John C. Fetzer | Duration:60 Minutes | Price: $150.00 | View Details
  • 28
  • May
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Personal Protective Equipment Requirements

Personal protective equipment, commonly referred to as "PPE", is equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses.

Robert A. (Bob) LaRosa Robert A. (Bob) LaRosa | Duration:60 Minutes | Price: $150.00 | View Details
  • 28
  • May
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

John N. Zorich John N. Zorich | Duration:90 Minutes | Price: $150.00 | View Details
  • 29
  • May
  • 2020
  • Friday
09:00 AM PDT | 12:00 PM EDT

Regulatory Challenges of Real-world Artificial Intelligence (AI) and Machine Learning (ML)

This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.

Angela Bazigos Angela Bazigos | Duration:90 Minutes | Price: $150.00 | View Details
  • 29
  • May
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

ISO 14001: What is Emergency Preparedness and Response?

With any environmental management system (EMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.

Mark Hammar Mark Hammar | Duration:60 Minutes | Price: $150.00 | View Details
  • 1
  • June
  • 2020
  • Monday
10:00 AM PDT | 01:00 PM EDT

Hazardous Material Release Reporting Requirements

Hazardous materials pose a danger to the environment. Federal regulations require immediate reporting to specific agencies (federal and local) in the event of a release to the environment.

Robert A. (Bob) LaRosa Robert A. (Bob) LaRosa | Duration:60 Minutes | Price: $150.00 | View Details
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