Webinar Search Results : 91 Upcoming webinars found.
Steven Walfish Thursday, January 10, 2017
11:00 AM PST | 02:00 PM EST
Duration:60 Minutes
Price: $699.00
by: Steven Walfish

Jerry Lanese Friday, August 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Jerry Lanese
Analytical Method Validation
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

Casper Uldriks Friday, August 23, 2019
09:00 AM PDT | 12:00 PM EDT
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.

Carolyn Troiano Friday, August 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Carolyn Troiano
Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).

Michael Esposito Friday, August 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Michael Esposito
Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.

Miles Hutchinson Monday, August 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Miles Hutchinson
Accelerate Data Base Analysis with Excel's Pivot Tables
Learn to create flexible data queries that refresh when the data does. Create, then Pivot your report to fit your needs. Filter your report with Excel's Slicer tool. Target production delays, efficiency gains, scrap rates, key demographics and so much more from your data. Learn how the gurus in your organization analyze their data so quickly and become one too!.

Steven Wachs Monday, August 26, 2019
10:00 AM PDT | 01:00 PM EDT
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.

MaryAnn Lawrence Tuesday, August 27, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: MaryAnn Lawrence
What every Analyst needs to Know about Lease Accounting Standard
This is the second of the trifecta of accounting changes that will change the face of financial reporting over the next couple of years. All those off balance sheet leases will now be on balance sheet. Yes all those office leases and copier leases will now be shown as debt.

Robert J. Russell Tuesday, August 27, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Robert J. Russell
BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now
The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.

Dennis Taylor Wednesday, August 28, 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.

John N. Zorich Wednesday, August 28, 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 C. Fetzer Wednesday, August 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: John C. Fetzer
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.

Angela Bazigos Wednesday, August 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Audit Trail Generation and Review
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

David Nettleton Thursday, August 29, 2019
10:00 AM PDT | 01:00 PM EDT
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. Increased use of software from automated manufacturing and quality systems means increased exposure.

Danielle DeLucy Thursday, August 29, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Danielle DeLucy
Understanding Aseptic Technique and Cleanroom Behavior
In sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It is providing sterility, safety, and efficacy to the sterile product, especially various injections for patients. Cleaning, Gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.

Dr. Afsaneh Motamed Khorasani Friday, August 30, 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). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.

John E Lincoln Tuesday, September 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: John E Lincoln
Verification vs Validation-Product, Process or Equipment and QMS Software
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.

Karl J Hemmerich Wednesday, September 4, 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.

Danielle DeLucy Wednesday, September 4, 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.

Michael Esposito Wednesday, September 4, 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.

Robert J. Russell Thursday, September 5, 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.

Steve Gompertz Thursday, September 5, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Steve Gompertz
Building a Better Quality Manual
Quality Manuals are too often long documents that contain little more than a regurgitation of the standard requiring the manufacturer to have one. They end up being daunting to employees, confusing to everyone except those in Quality, difficult to maintain, and ultimately, a failure to meet the intent of the standard.

Mike Thomas Thursday, September 5, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Mike Thomas
Create and Use Excel Dashboards to Gain Valuable Business Insights
No matter what business you are in, a dashboard is a critical tool in your communication armoury and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility and the fact that most people have it installed on their computer.

Miles Hutchinson Thursday, September 5, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Miles Hutchinson
Complying with FATCA - the Foreign Accounts Tax Compliance Act
FATCA was enacted by Congress in 2010 as part of the HIRE Act. It attempts to restore tax fairness by focusing on foreign financial assets of US Citizens that are not being properly reported and taxed. With the announcement of final regulations in February, 2013, the US Department of the Treasury and the IRS have been busy designing, implementing and executing intergovernmental agreements, new and revised forms, and instructions to force US Citizens and foreign financial institutions into compliance.

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.

Michael Abitz Friday, September 6, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Michael Abitz
Fishbone Diagramming
Fishbone Diagramming 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.

Angela Bazigos Friday, September 6, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Changing your Marketed Device? You Might Need a New 510(k)
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 Friday, September 6, 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.

Roger Cowan Monday, September 9, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Roger Cowan
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
It is important that the sterile filtration process is fully understood and properly validated for your particular application.

Peter Vishton P.E. Monday, September 9, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Peter Vishton P.E.
FDA - Is Your cGMP Water System Ready for their Visit?
cGMP pharmaceutical water systems require specific Design, Documentation, Manufacturing, Installation, Testing, Commissioning, Start Up, Validation, Quality Testing and Extended Operation to become available for pharmaceutical manufacturing of products for sale.

Perry Saidman Tuesday, September 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Perry Saidman
The Basics of U.S. Design Protection
Protection of a product's unique design is increasingly important in today's design-driven competitive economy. And yet, how to go about getting such protection is frequently misunderstood. This Webinar will cover the basic legal tools of design protection in the US: copyright, trade dress, and design patents, with ample illustrations. The pros & cons of each will be explored, as well as recommendations on which to use in any particular situation.

Charles H. Paul Tuesday, September 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Charles H. Paul
Risk Management in Medical Device Design
The webinar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation.

Carolyn Troiano Tuesday, September 10, 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.

Dennis Taylor Wednesday, September 11, 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:

John N. Zorich Wednesday, September 11, 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.

David Nettleton Wednesday, September 11, 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.

Swasita Saigal Wednesday, September 11, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Swasita Saigal
Conducting Management Review for Medical Devices; Small Business Perspective
Management review can be burdensome and difficult if not planned to focus on the right metrics and administered by an efficient process. Management with executive responsibility must review the suitability and effectiveness of the quality system.

Yuval Shapiro Thursday, September 12, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Yuval Shapiro
CAPA - BulletProof Per ISO13485: 2016
FDA, EU Notified Bodies and other regulatory authorities investigate the capability of organizations to identify processes that require corrective and preventive actions.

Edwin Waldbusser Thursday, September 12, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Edwin Waldbusser
Software Validation for the New FDA Inspections
This course will teach how to conduct a software validation program 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. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

Susanne Manz Friday, September 13, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Susanne Manz
Essentials of Validation - IQ, OQ, PQ
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.

Angela Bazigos Monday, September 16, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

Karl J Hemmerich Monday, September 16, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Karl J Hemmerich
Validating Radiation Sterilization for Medical Products
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

Charles H. Paul Monday, September 16, 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.

John E Lincoln Tuesday, September 17, 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".

Robert J. Russell Tuesday, September 17, 2019
12:00 PM PDT | 03:00 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.

Teri C. Soli Tuesday, September 17, 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?

Mike Thomas Wednesday, September 18, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Mike Thomas
Excel: VBA 101 -Automation Beyond the Macro Recorder
Do you find yourself repeatedly performing the same actions or tasks in your spreadsheets? If the answer is "Yes", it's time to learn how to create a macro.

Peggy Berry Wednesday, September 18, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Peggy Berry
Complaint Handling
The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages.

Miles Hutchinson Thursday, September 19, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Miles Hutchinson
Forecasting with Excel's Powerful Sensitivity Tools
Attend this briefing and demonstration on Excel to unleash its powerful sensitivity tools. Get the full power out of your financial models. Improve the design of your models to take advantage of these tools in just 2 hours.

Angela Bazigos Thursday, September 19, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Steve Gompertz Friday, September 20, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Steve Gompertz
Meaningful Quality System Process Monitoring
When considering the requirements for process monitoring and measurement, the first thought is usually in regard to production processes. However, ISO 13485 and ISO 9001 require companies to monitor and measure all quality system processes.

Casper Uldriks Monday, September 23, 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.

Danielle DeLucy Monday, September 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Danielle DeLucy
Developing an Effective CAPA Management and Root Cause Analysis System
In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner.

Charles H. Paul Monday, September 23, 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
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.

Angela Bazigos Tuesday, September 24, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts
With the emerging utilization of computerized technologies in the late 1980s and early 1990s, the pharmaceutical industry asked the FDA for guidance regarding compliance of the resulting electronic records. After several years of development and industry comments, 21 CFR Part 11, the Electronic Records & Electronic Signatures Rule became law in 1997.

Michael Esposito Tuesday, September 24, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Michael Esposito
Bad Standard Operating Procedures (SOPs) = Bad Training: Garbage In, Garbage Out
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 how the writing of a procedure can have a positive or negative impact on training.

Willy Vandenbrande Tuesday, September 24, 2019
10:00 AM PDT | 01:00 PM EDT
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 N. Zorich Wednesday, September 25, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Yuval Shapiro Wednesday, September 25, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Yuval Shapiro
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. It tells which category is to be surveyed, what should be the sample size and how the respondents should be chosen out of the population.

Robert J. Russell Wednesday, September 25, 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.

Roger Cowan Thursday, September 26, 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.

Danielle DeLucy Thursday, September 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Danielle DeLucy
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.

Edwin Waldbusser Thursday, September 26, 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.

Susanne Manz Friday, September 27, 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.

Angela Bazigos Friday, September 27, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Food Facility Inspection
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

Robert J. Russell Monday, September 30, 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, October 1, 2019
10:00 AM PDT | 01:00 PM EDT
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.

Susanne Manz Wednesday, October 2, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Susanne Manz
Quality is not an Organization
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Steve Gompertz Thursday, October 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Steve Gompertz
Practical Training & Employee Competency Management
Training management is often focused only on aligning standard operating procedures with job titles, and tracking whether employees have been "trained" to the latest versions. But, quality standards and regulations actually focus on employee competence and awareness of their impact on quality.

Angela Bazigos Friday, October 4, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds
The presentation further describes evaluation criteria for methods to detect, identify and quantify all microbial analytes that may now be, or have the potential to be associated with foods and feeds, i.e. any microbiological organism of interest (target organism) or the genetic material i.e. DNA, RNA, toxins, antigens or any other product of these organisms.

Yuval Shapiro Monday, October 7, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Yuval Shapiro
ISO13485: 2016 - Quality Management Systems for Medical Devices
This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU. Prior to engaging the process of establishing and certifying a QMS for medical devices or enhancing the QMS to the newly introduced requirements, a review of those requirements and how to approach them is important.

Charles H. Paul Monday, October 7, 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.

Michael Esposito Tuesday, October 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Michael Esposito
Strategies to Prevent Manufacture and Distribution of Substandard Medications
Substandard product can exist even if the product itself is manufactured according to quality standards. Muhammad H. Zaman, in his book Bitter Pills, recalls his visit to a warehouse in Ghana that had no climate control, with temperatures in the warehouse reaching 95 degrees Fahrenheit.

Roger Cowan Wednesday, October 9, 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.

Edwin Waldbusser Wednesday, October 9, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Edwin Waldbusser
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.

David Nettleton Wednesday, October 9, 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).

Angela Bazigos Wednesday, October 9, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Audit Trail Generation and Review
Computerized systems are used throughout the life sciences industry to support various regulated activities,which in turn generate many types of electronic records.

Swasita Saigal Thursday, October 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Swasita Saigal
Conducting An Effective Recall (Managing Internal and External Customers)
The webinar will cover what it takes in conducting an effective recall. You will learn practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up or a regulatory action. You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business.

Willy Vandenbrande Wednesday, October 16, 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.

John E Lincoln Wednesday, October 16, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: John E Lincoln
EU ISO 13485:2016 Medical Device Quality Management System
This webinar will examine the basic elements of the EU's QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical device industry QMS failings, as well as how ISO 13485 interfaces with the EU MDR (Medical Device Regulation).

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.

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.

Angela Bazigos Tuesday, October 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts
With the emerging utilization of computerized technologies in the late 1980s and early 1990s,the pharmaceutical industry asked the FDA for guidance regarding compliance of the resulting electronic records.

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.

Edwin Waldbusser Wednesday, October 23, 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.

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:

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
A Second Life for SPC: From Control to Management
Statistical Process Control (SPC) is a fundamental technique in quality management and one of the first successful applications of statistics in the control of industrial processes. Until today it is a mandatory tool in the automotive industry and a vital element in many quality courses. A large number of people are going through SPC courses, from quality and process engineers to machine operators

Peggy Berry Monday, November 4, 2019
10:00 AM PDT | 01:00 PM EDT
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.

John E Lincoln Wednesday, November 13, 2019
10:00 AM PDT | 01:00 PM EDT
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.