Webinar Search Results : 46 Upcoming webinars found.
Robert J. Russell Friday, August 16, 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.

Danielle DeLucy Monday, August 19, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Danielle DeLucy
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.

David Nettleton Tuesday, August 20, 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).

Todd B. Graham Wednesday, August 21, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Todd B. Graham
SOP's for Bioanalytical Methods Validation
The webinar will include the following critical information you will need:

Steven Laurenz Wednesday, August 21, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Steven Laurenz
Quality Risk Management Overview
Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM, explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions.

Susanne Manz Wednesday, August 21, 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.

Charles H. Paul Thursday, August 22, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Charles H. Paul
3-Hour Virtual Seminar on Project Management for Non-Project Managers
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Michael Esposito Thursday, August 22, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Michael Esposito
Using a Learning Management System (LMS) to Develop Pharma Training Curricula
Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Carolyn Troiano Thursday, September 12, 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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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