Webinar Search Results : 104 Upcoming webinars found.
Steven Walfish Thursday, January 10, 2017
11:00 AM PST | 02:00 PM EST
Duration:60 Minutes
Price: ¤799.00
by: Steven Walfish

Ginette Collazo Tuesday, October 16, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Ginette Collazo
3-Hour Virtual Seminar on How to Implement an Effective Human Error Investigation Program
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Robert J. Russell Tuesday, October 16, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Robert J. Russell
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Lynn Fountain Wednesday, October 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Risk Based Internal Auditing - Establishing the Methodology
True RBIA incorporates cascading the process through to each individual audit as well as the audit reporting process. The training program will focus on the establishment of a framework or methodology for RBIA and examine how to utilize risk-based questions within the process steps.

Angela Bazigos Wednesday, October 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's 21 CFR 11 Add-On Inspections - Recent Updates
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

Angela Bazigos Thursday, October 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's Enforcement of 21 CFR Part 11 Compliance
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

John Chapman Thursday, October 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Chapman
Medical Device Complaints, MDRs & Recalls
This webinar will help you to understand complaint handling processes and to reap the benefits of valuable product feedback. The identification of the problem, actual cause of the problem,documentation and regulatory reporting is discussed.Consequences of inadequate investigations are pointed out,including FDA Warning Letters and financial losses.The presentation will also review the regulations and point out some of the pitfalls as well as benefits of complaint handling and reporting.

Lamont M. Fulton Friday, October 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Lamont M. Fulton
Evaluating and Selecting a CMO
Pharmaceutical firms must establish clear process of selecting a Contract Manufacturing Organization to perform the selected task or need. It is incumbent on the Pharmaceutical firm, large or small, to develop a criteria for evaluating a CMO.

Emil W Ciurczak Friday, October 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak

Eyal Lerner Friday, October 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eyal Lerner
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

Amer Alghabban Friday, October 19, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Amer Alghabban
3-Hour Virtual Seminar - Good Pharmacovigilance Practice
Pharmacovigilance or drug safety -is a broad term that describes the Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions.

Dr. Ludwig Huber Monday, October 22, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Laura Brown Monday, October 22, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:2 Hours
Price: ¤190.00
by: Laura Brown
2-Hour Virtual Seminar on Data Integrity for GXP Compliance
Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This webx session will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

Robert J. Russell Monday, October 22, 2018
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.

Carolyn Troiano Monday, October 22, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
The 21st Century Cures Act - Expediting New Products and New Product Indications
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

Roger Cowan Tuesday, October 23, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Roger Cowan
HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. 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. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product.

John E Lincoln Tuesday, October 23, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: John E Lincoln
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

Angela Bazigos Tuesday, October 23, 2018
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 Process
Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.

Edwin Waldbusser Tuesday, October 23, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Edwin Waldbusser
Computer System Validation
FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Validation is more than testing. It is testing plus design control and configuration management.

Thomas Bento Wednesday, October 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Thomas Bento
Validation of Non-Product Software
This course will teach how to comply to 21 CFR Part 820.70(i) and effectively implement a software validation program for medical devices, meeting the FDA requirements and produce a safe product. We will explain the role of Risk Management in Non-Product Validation. How software requirements are used in validation will be described.

Ginette Collazo Wednesday, October 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Training in Human Error: Reducing Training Related Errors
We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.

Dr. Shuguang Huang Thursday, October 25, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:2 Hours
Price: ¤190.00
by: Dr. Shuguang Huang
2-Hour Virtual Seminar - Biomarker Development and Validation - A Statistical Perspective
Biomarker is very critical in pre-clinical drug discovery, clinical translational research, diagnostic product (including companion diagnostic) development. This webinar will focus on three areas:

Dennis Taylor Thursday, October 25, 2018
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.

Susanne Manz Thursday, October 25, 2018
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. You'll learn the essentials of validation planning, protocol writing, and change management

Danielle DeLucy Thursday, October 25, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
FDA's Expectations from Supplier Management for GMP: Quality Agreements and More
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

Angela Bazigos Friday, October 26, 2018
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, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).

Marina Malikova Friday, October 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Marina Malikova
Trial Master File Requirements and Essential Regulatory Documents
Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed.

Charles H. Paul Monday, October 29, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
FDA Best Audit Behavior Practices - Do's and Don'ts
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

John N. Zorich Wednesday, October 31, 2018
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.

Angela Bazigos Wednesday, October 31, 2018
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
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

Yingying Liu Thursday, November 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Yingying Liu
Pharmaceutical Drug Registration in China
Bringing pharmaceutical products to market in China has become much easier for foreign companies. The Chinese FDA (CFDA), now renamed as CNDA, recently made a series of significant changes to the marketing authorisation regulations by issuing a large number of guidelines and opinions (in Chinese).

Lynn Fountain Thursday, November 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Becoming a Chief Audit Executive - Leading the Internal Audit Function
This training program will enumerate the IIA Standards and the auditor's responsibility to abide by the standards. The program will also look at management's expectations of internal audit and detail skills required for internal audit management. It will provide real-world examples and challenges facing today's internal audit.

David Nettleton Thursday, November 1, 2018
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.

Carly Souther Thursday, November 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Carly Souther
Cultivating a Cybersecurity Continuity Culture: 10-Step Checklist for Compliance
Despite the fact that a majority of United States organizations have experienced a cyber-attack either directly or through a vendor, U.S. businesses do not consistently address cyber threats.

Rayleen M. Pirnie Thursday, November 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Rayleen M. Pirnie
Handling Consumer ACH Disputes: Advanced ACH Sticky Situations
This ACH training program will review common consumer issues and situations while handling ACH disputes. It will guide participants in deciding the appropriate course of action in given situations. Participants will also learn what to do when a customer/member won't complete a WSUD.

Carolyn Troiano Friday, November 2, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar Computer System Validation (CSV) for FDA-Regulated Computers
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

Wayne Taylor Monday, November 5, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Wayne Taylor
Validation Sampling Plans for Process Validation, Design Verification and CAPA Effectiveness Checks
This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:

Dr. Ludwig Huber Tuesday, November 6, 2018
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

Casper Uldriks Tuesday, November 6, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
FDA's New Import Program for 2018
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

Jerry Lanese Tuesday, November 6, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Jerry Lanese
Laboratory Investigation of Out-of-Specification Results
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

Marina Malikova Tuesday, November 6, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Marina Malikova
ICH GCP Guidelines E6 Revision, R2 Addendum- Changes Impacting Sponsors-CRO-Sites
Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed up clinical development.

Derk Yntema Wednesday, November 7, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Derk Yntema
3-Hour Virtual Seminar on GDPR - European Privacy Regulation what and how
The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

Karl J Hemmerich Wednesday, November 7, 2018
10:00 AM PST | 01:00 PM EST
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.

Edwin Waldbusser Wednesday, November 7, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Edwin Waldbusser
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This webinar details the regulation and how it applies to computerized systems.

Susanne Manz Thursday, November 8, 2018
10:00 AM PST | 01:00 PM EST
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.

Tom Fragale Friday, November 9, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Tom Fragale
Advanced Formulas & Functions in Excel
In the business world, or within your organization, you probably experience large amounts of data. Maybe the data is about your sales, customers, donations, orders, employees, vendors, expenses, or whatever it may be.

Dr. Shuguang Huang Friday, November 9, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Dr. Shuguang Huang
3-Hour Virtual Seminar - Assay Validation According to CLSI Guidelines
Bioassay development and validation is very critical in pre-clinical drug discovery, clinical biomarker and translational research, diagnostic product (including companion diagnostic) development. In this presentation, overview if given for the terminologies, the scientific principles, and the regulatory guidelines that are related to assay validation.

Dr. Afsaneh Motamed Khorasani Friday, November 9, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Afsaneh Motamed Khorasani
Good Documentation and Record Keeping Best Practices (FDA & EMA)
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

Danielle DeLucy Friday, November 9, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
How to Conduct Successful Supplier Audits
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.

Carolyn Troiano Friday, November 9, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries.

Laura Brown Monday, November 12, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
How to Write SOPs which are Compliant for Inspections for a GXP Compliance
This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.

Angela Bazigos Monday, November 12, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on 2018 Updates on FDA's Refuse to Accept Policies for 510(k)s and PMAs Including Combination Products
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released updated guidance documents on its policies for refusing to accept 510(k)s and refusing to accept and file reviews for premarket approval applications (PMAs).

Dennis Taylor Monday, November 12, 2018
09:00 AM PST | 12:00 PM EST
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:

Dr. Subodh Bhardwaj Monday, November 12, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Dr. Subodh Bhardwaj
Current Challenges in Vaccine Pharmacovigilance and Risk Mitigation Strategies
This topic covers all the possible factors responsible for monitoring adverse events (AEs) to vaccines of different manufacturers, routes of administration and strains. The pitfalls of new technologies in vaccine production and their impact on effective PV. How to be compliant and accurate in SAE detection and assessment, management.

Angela Bazigos Tuesday, November 13, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.

John N. Zorich Wednesday, November 14, 2018
10:00 AM PST | 01:00 PM EST
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.

Carly Souther Wednesday, November 14, 2018
12:00 PM PST | 03:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Carly Souther
3-Hour Virtual Seminar - The FDA Deeming Rule & the Current State of Electronic Nicotine Dispensing Systems (ENDS) Regulation
In the wake of the JUUL's unexpected rise to social media stardom, 2018 has been a busy year for vapor-related action at the federal and state levels. This webinar will take an in-depth dive into both the business and regulatory aspects of electronic vaping devices. We will review a timeline of the U.S. vapor industry and its regulation. We will cover milestones of the FDA's Comprehensive Plan for Tobacco and Nicotine Regulation, as well as key policy issues and the health impacts of nicotine.

Angela Bazigos Wednesday, November 14, 2018
10:00 AM PST | 01:00 PM EST
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.

Susanne Manz Thursday, November 15, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Risk Management Techniques for Medical Devices
Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

Amer Alghabban Friday, November 16, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Amer Alghabban
3-Hour Virtual Seminar Data Integrity in Clinical Trials
Clinical trials' data gives an accurate representation of what we measure to evaluate effects of the treatments under comparison. The clinical data recording process, however, as inspected/audited by inspectors/auditors is initiated with the recorded data, either in the Case Report Form, or in some other system, or in an electronic database.

Emil W Ciurczak Friday, November 16, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Control-Analysis Instrumentation used in PAT and Continuous Manufacturing
We will briefly discuss how to go from minimum sampling, sending them to a lab, and waiting for results, to real-time monitoring, taking huge numbers of readings, and how to understand and apply these data to control and improve new and existing products.

Rayleen M. Pirnie Friday, November 16, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Rayleen M. Pirnie
The Board of Directors Role in Cybersecurity
This webinar will break down the Board's role in effective cybersecurity oversight, the 12 questions a board member should be knowing to answer, key principles of oversight, tips and resources for board.

Susanne Manz Monday, November 19, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Secrets to Writing Effective SOPs for Medical Device QMS
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

Angela Bazigos Monday, November 19, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking
This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.

Dr. Ludwig Huber Tuesday, November 20, 2018
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Lynn Fountain Tuesday, November 27, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Auditing and Examining Travel and Entertainment Expenses: Expense Reimbursement Fraud
This training program will address why internal controls over travel and entertainment (T&E) expenditures are a critical component of the control environment. Although the topic of travel and entertainment abuse is not one that management likes to address, it is a very important indicator of the adequacy of a company's control environment.

David Nettleton Tuesday, November 27, 2018
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: David Nettleton
How to Validate Software for SaaS-Cloud-Local Hosting
This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based approach to COTS software validation minimizes documentation and ensures efficient implementation of new and upgraded computer systems.

Joe Lynch Tuesday, November 27, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Joe Lynch
Block Chain Made Easy - Introduction and Basics for Non-Techies
Once a block is written to the blockchain it can't be altered by anyone. If somebody tries to introduce a fake transaction into the ledger, he can only do so by adding it to all copies of distributed ledger (which is not possible, as every block is cryptographically linked with previous and next block) else that transaction is spotted and will be removed. Before a record is written to the blockchain, it needs to be verified and this is done by special nodes (computers) called miners.

Carolyn Troiano Tuesday, November 27, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar - 21 CFR Part 11 - Guidance for Electronic Records and Electronic Signatures used in FDA-Regulated Computer Systems
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

Dennis Taylor Tuesday, November 27, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dennis Taylor
Excel Formulas and Functions
Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Jerry Lanese Wednesday, November 28, 2018
10:00 AM PST | 01:00 PM EST
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.

Angela Bazigos Wednesday, November 28, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's Enforcement of 21 CFR Part 11 Compliance
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

Karl J Hemmerich Wednesday, November 28, 2018
10:00 AM PST | 01:00 PM EST
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.

Carly Souther Wednesday, November 28, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Carly Souther
The Modernization of "Milk": FDA Review of Dairy Terms in Plant-Based Product Labeling
Discover the increasing risks that stakeholders in the dairy industry are confronting with respect to the use of "dairy" terms in plant-based product labeling.

Rayleen M. Pirnie Wednesday, November 28, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Rayleen M. Pirnie
Cyber Incident Response Plans: Planning for the Inevitable
This webinar training analyzes critical components of a Cyber Incident Response Plan and provides recommendations on how to prepare all staff for the inevitable situations. From internal considerations to your external solution providers, get a realistic view of how a cyber-attack can quickly spiral a typical day into complete chaos and cause significant losses without preparation.

Dr. Shuguang Huang Thursday, November 29, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Shuguang Huang
Statistics in Non-Clinical Development
In this webinar, I will give an overview of the use of statistics in different non-clinical fields, which mainly include

Susanne Manz Thursday, November 29, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Addressing CAPA within a Device Quality System
This webinar will help you ensure an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you.

Ginette Collazo Thursday, November 29, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Shep Bentley Friday, November 30, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Shep Bentley
3-Hour Virtual Seminar on Medical Device Single Audit Program (MDSAP) Preparation
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

Danielle DeLucy Friday, November 30, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Danielle DeLucy
Handling OOS Test Results and Completing Robust Investigations
This training program will provide participants with a This training program will describe when a full investigation should be triggered and the frequency for re-testing and re-sampling. Attendees will also learn how to implement corrective and preventive action plans (CAPA).

Laura Brown Friday, November 30, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
How to Audit Against ICH GCP 2 Addendum to Ensure Compliance
It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year. The new guideline includes a number of "hot" GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as risk-based approaches for running clinical trials. These new approaches are going to be areas inspectors will be focussing on.

Angela Bazigos Monday, December 3, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Writing Effective SOPs
Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?

Danielle DeLucy Monday, December 3, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
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.

Joe Lynch Tuesday, December 4, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Joe Lynch
Block Chain Transformation: Understanding the Impacts and Applications in the Logistics Industry
The logistics industry is huge, worldwide and critical to our global economy. The industry consists of transportation, warehousing, logistics and technology companies that move goods (physical assets) from producers to consumers.

John N. Zorich Wednesday, December 5, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: John N. Zorich
Valid Statistical Rationales for Sample Sizes
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Dr. Shuguang Huang Wednesday, December 5, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Shuguang Huang
Statistical Quality Control in Pharmaceutical and IVD Industries
Process validation is the establishment of documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre- determined specifications and quality characteristics.

Laura Brown Wednesday, December 5, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
How to Demonstrate Vendor-CRO-CMO Oversight in the Biopharma and Device Industry
This webinar is specifically designed for sponsoring biopharma and device companies who are outsourcing.It will help you get to grips with effective Vendors (including CRO,CMO, and other vendors) management used in the biopharma and device industries and your responsibilities as the sponsor.

Tom Fragale Friday, December 7, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Tom Fragale
Getting Meaningful Results from your Data with Excel PowerPivot and PowerQuery
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources. Luckily there are two Microsoft tools- PowerPivot and PowerQuery-that solve ALL of these issues, right inside Excel.

Marina Malikova Friday, December 7, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Marina Malikova
Essential Regulatory Documents and Regulatory Requirements
Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed.

Emil W Ciurczak Friday, December 7, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Theory and Practice of Near-Infrared Spectroscopy (NIRS)
NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with "commonly used" spectrometers, now in use and more familiar to analysts.

Carolyn Troiano Friday, December 7, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar - Best Practices to Help you Pass an FDA Computer System Validation Audit
FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.This webinar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.

Lamont M. Fulton Friday, December 7, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Lamont M. Fulton
Change Controls : How to Determine the Appropriate Levels and Reporting Categories
Change management system should be structured according to the firms Pharmaceutical Quality System (PQS) and should be based on ICH Q8, ICH Q9, and ICH Q10.

Charles H. Paul Monday, December 10, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Charles H. Paul
3-Hour Virtual Seminar on Project Management for Non-Project Managers
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Dr. Subodh Bhardwaj Monday, December 10, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Subodh Bhardwaj
Seasonal Influenza Vaccines- Current Concepts and Future Trends for Effective Immunization
To provide current concepts in seasonal influenza vaccines for the 2018-2019 season

David Nettleton Tuesday, December 11, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: David Nettleton
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR).

Rayleen M. Pirnie Tuesday, December 11, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Rayleen M. Pirnie
Handling Situations Where Regulation E and ACH Don't Align
This training program will review intent and focus of Regulation E and the ACH Rules.It will analyze situations where Regulation E and the ACH Rules do not align and help determine appropriate responses and procedures to manage risk and loss.

Angela Bazigos Wednesday, December 12, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Excel Spreadsheets for 21 CFR 11 Compliance
Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

Steven Wachs Wednesday, December 12, 2018
10:00 AM PST | 01:00 PM EST
Duration:75 Minutes
Price: ¤150.00
by: Steven Wachs
Sample Size Determination for Design Validation Activities
Statistical Methods are typically used to ensure that product performance, quality, and reliability requirements are met during the Design Validation phase of product development. This webinar discusses common elements of sample size determination and several specific sample size applications for various design validation activities including Reliability Demonstration/Estimation, Acceptance Sampling, and Hypothesis Testing.

Angela Bazigos Tuesday, January 8, 2019
10:00 AM PST | 01:00 PM EST
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.

Angela Bazigos Wednesday, January 16, 2019
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.

Angela Bazigos Wednesday, January 23, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
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. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

Angela Bazigos Wednesday, February 6, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Lean Document Control for Manufacturing in Life Sciences
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

Angela Bazigos Wednesday, February 13, 2019
10:00 AM PST | 01:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Off label Promotion of Drugs and Medical Devices - FDA's Latest
Off Label Promotion for Drugs and Medical Devices is a controversial topic which often puts FDA and industry at loggerheads. FDA continues to need to ensure public health by protect public health by ensuring that medical products distributed in the United States are safe and effective for their intended use while industry believes that safe and effective off label use is warranted. It is further complicated by today's patient who is much more savvy with regards to treatment and sometimes demands off-label use of products.

Angela Bazigos Wednesday, February 20, 2019
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
European Data Protection Regulation - Latest
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.

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