Webinar Search Results : 100 Upcoming webinars found.
Michael Esposito Friday, April 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Michael Esposito
Packaging and Labeling in the Pharmaceutical Supply Chain
Packaging and Labeling form a bridge between the conception of a product and its realization and distribution, and consequently occupy a critical position in the success or failure of any pharmaceutical product launch or revision. Decision-makers need at least a cursory knowledge of potential pitfalls to create contingencies, as it is easier and more cost-effective to change things earlier in process than later.

Sheldon Primus Friday, April 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Sheldon Primus
Laboratory Safety: Don't be Caught Unaware of Laboratory Hazards
In this webinar, we will explore the hazards related to the laboratory on many fronts. To understand the laboratory work environment as it relates to safety, the employer must consider what the materials the workers are exposed to on a daily basis.

Carolyn Troiano Friday, April 20, 2018
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
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.

Peggy Berry Friday, April 20, 2018
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. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Jd Marhevko Friday, April 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jd Marhevko
Driving a Quality-Lean Steering Committee
This session demonstrates how to develop, manage, and implement an effective quality Lean Management System (QLMS) steering committee. Attendees will observe the development of the key components of a steering committee. Several successful examples across various business types will be shared. Attendees will walk away with a model that they can apply to their own organizations.

Dennis Taylor Tuesday, April 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Dennis Taylor
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.

John E Lincoln Wednesday, April 25, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John E Lincoln
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Michael Aust Thursday, April 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Michael Aust
Focus 4 Construction Hazards - Effective Operational Controls to Minimize Hazards on your Worksite
The Occupational Safety and Health Administration (OSHA) identified the 4 leading causes of fatalities in the Construction Industry. This webinar will review these Fatal Four Hazards which include Electrical Hazards, Fall Hazards, Struck by Hazards and Caught-In or Caught-Between Hazards.

Angela Bazigos Thursday, April 26, 2018
12:30 PM PDT | 03:30 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Best Achieve Pharmaceutical Supply Chain to Avoid Adverse Inspection Results
One of the practical implications of the FDA's challenge is the restructuring of a company's supply chain. A company will need to manage its risks across products, technologies, and sites, and ensure that its drugs are safe at the point-of-use. This webinar will show the participant how to best achieve this to avoid adverse inspection results or harm to patients.

Heath Suddleson Thursday, April 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Heath Suddleson
Does the Boss Really have Horns? Improving Relationships with Bosses
Managers are usually promoted to their role because of their technical skills and not their people skills. In fact, studies have shown almost a decade gap between when people get promoted and when people begin to seek out leadership skills. If you can understand where your boss is in the process, you may be able to help them become the boss you want them to be.

Dr. Saeed Qureshi Thursday, April 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Dr. Saeed Qureshi
Understanding Concepts of Convolution - Deconvolution, in vitro-in vivo Correlations (IVIVC) and Predicting Plasma Drug Levels
This webinar will focus on defining and explaining numerous concepts and terminologies, and their interrelationships, in simple language as related to: convolution/deconvolution, in vitro-in vivo correlations (IVIVC) plasma drug concentration-time profiles/curves, rates of absorption and elimination, Cmax, Tmax, half-life, AUC, apparent volume of distribution. In addition, webinar will highlight applications of such concepts for the bioavailability/bioequivalence assessment of pharmaceutical products required for regulatory compliance.

David Ringstrom Thursday, April 26, 2018
08:00 AM PDT | 11:00 AM EDT
Duration:60 Minutes
Price: ¤150.00
by: David Ringstrom
Master Excel: Transcend the VLOOKUP Function
Excel expert David Ringstrom, CPA, introduces several lookup functions, including VLOOKUP, HLOOKUP, MATCH, and CHOOSE, in this valuable presentation. These powerful Excel functions allow you to rapidly develop accurate spreadsheets and look up information, such as pay rates, item prices, and accounting results, versus manually linking to specific cells. David explains the context of when to use lookup functions, demonstrates troubleshooting techniques, and prepares you to deal with subtle issues that can prevent them from working properly.

Robert E. Davis Thursday, April 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Robert E. Davis
Identifying Information Security Risks in the Supply Chain
A firm's climate and linked environment should reflect a culture promoting cross-process cooperation and teamwork, supporting compliance and continuous process improvement, and managing process variations well. Supply chain and business processes strategies should reflect connectivity and rational selection. Thereby, the integration and security of information flows is a prerequisite to aligning and streamlining processes as well as protecting information assets.

Charles H. Paul Friday, April 27, 2018
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.

Danielle DeLucy Friday, April 27, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Peggy Berry Friday, April 27, 2018
11:30 AM PDT | 02:30 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Peggy Berry
Drug Development History & Overview
During discovery, thousands of compounds may be potential candidates for development as a medical treatment. After early testing, however, only a small number of compounds will go on to further study.

Michael Esposito Monday, April 30, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Michael Esposito
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.

Dr. Ludwig Huber Monday, April 30, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Susanne Manz Monday, April 30, 2018
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. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.

Mika Reinikainen Monday, April 30, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Mika Reinikainen
Market Surveillance and Traceability
The webinar will describe the post-market (post-production) environment in terms of the regulatory compliance dynamics. The responsibilities of national competent authorities in carrying out market surveillance have been defined in detail. The European Commission may also act to safeguard public health if a Member State fails to do it.

Carolyn Troiano Tuesday, May 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Good Documentation Practices to Support FDA Computer System Validation
As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.

John Ryan Tuesday, May 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Ryan
Food Safety and Quality in Home Food Delivery
The food home delivery business is exploding. While most companies and consumers have never worried about food safety when ordering Pizza or Chinese foods by telephone, the home food delivery market has now reached a $46 billion level and is expected to hit over $76 billion per year by 2022.

John E Lincoln Tuesday, May 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John E Lincoln
Dietary Supplements CGMPS - 21 CFR 111 Compliance
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

John N. Zorich Tuesday, May 1, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Casper Uldriks Tuesday, May 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
FDA's Revolutionary Change in Software Regulation
Congress recognized that FDA struggles with software regulation. So, Congress removed some software out of FDA's jurisdiction. Now FDA must revise its premarket and postmarket software regulatory approach, including mobile apps. Using voluntary standards in premarket submissions can be used more effectively. Even more dramatic, FDA's new Digital Health initiative turns FDA's premarket clearance program on its head.

David Ringstrom Wednesday, May 2, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: David Ringstrom
Microsoft Excel 2016 Benefits and Hazards in Office 365
In this valuable presentation, Excel expert David Ringstrom, CPA, explains how the Office 365 version of Excel 2016 differs from previous versions and perpetual licensed versions of Excel 2016. Historically, each major version of Excel was identical for all users, but that's no longer the case. David covers the updated features and worksheet functions available in the Office 365 version of Excel 2016 and shows you step-by-step how to use them. He also shares keyboard shortcuts and tips that will help you work more efficiently in Excel.

Karl J Hemmerich Wednesday, May 2, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Karl J Hemmerich
Accelerated Aging Techniques for Medical Device Products
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.

Steven S. Kuwahara Thursday, May 3, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Steven S. Kuwahara
Auditing Analytical Laboratories for FDA Compliance
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Thomas E. Colonna Thursday, May 3, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Thomas E. Colonna
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Dr. Ludwig Huber Thursday, May 3, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Understanding and Implementing USP 1058 Analytical Instrument Qualification
This webinar will discuss all details and give strategies and case studies for easy implementation. The first version of USP <1058> has been released in 2008. Since then it has evolved to the global standard for analytical instrument qualification. In August 2017 a new revision has been released with many new requirements mainly addressing the needs of quality systems, e.g., risk based implementation, quality agreements between service/system providers and users, and regular reviews to ensure ongoing performance and more.

Mike Thomas Friday, May 4, 2018
12:00 PM PDT | 03:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Mike Thomas
Mastering Excel Formulas and Functions
Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job.

Marina Malikova Friday, May 4, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Marina Malikova
Fundamentals of Risk Management in Clinical Research
Besides being a new expectation by regulatory agencies under good clinical practices, Quality by Design (QbD) and Risk-Based Quality Management (RBQM) concepts are receiving attention on a world-wide basis. As the industry's utilization of risk-based monitoring continues to increase along with the development and expansion of the area of RBQM, the need for the integration of these two concepts becomes apparent.

John C. Fetzer Monday, May 7, 2018
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.

Robert J. Russell Tuesday, May 8, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Robert J. Russell
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies.

Lauren Neighbours Tuesday, May 8, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Lauren Neighbours
Understanding Regulatory Expectations for Diversity in Clinical Trials
In line with the push towards more patient-centric approaches to clinical development, regulatory agencies are committed to ensuring clinical studies enroll participants that reflect the demographics of the target indication and patient population for the to-be-marketed product. This presentation will explore current regulatory expectations surrounding diversity inclusion in clinical research and provide insight on potential strategies to meet these expectations in your development program.

Casper Uldriks Tuesday, May 8, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Michael Esposito Wednesday, May 9, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Michael Esposito
Bad SOPs, Bad Training: Garbage In, Garbage Out
The relationship between SOPs and training is not a common topic but one that affects a large number of employees in the manufacturing sector of pharmaceutical companies. For an SOP to be effective, it has to describe the process with an appropriate level of detail, striking a balance between flexibility and structure. If the writing of the SOP is not written with this objective in mind, it is likely to have a negative impact on training, because text that is ambiguous in the SOP will also be ambiguous in the training. In addition, an SOP is written to capture the essential steps of a process accurately, and its language tends to be "legalese."

Susanne Manz Wednesday, May 9, 2018
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.

Danielle DeLucy Wednesday, May 9, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 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. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Angela Bazigos Wednesday, May 9, 2018
12:30 PM PDT | 03:30 PM EDT
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.

John N. Zorich Wednesday, May 9, 2018
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.

Heath Suddleson Wednesday, May 9, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Heath Suddleson
The High Cost of Bad Management
Failing to train managers to be leaders can be very costly.

Eleonora Babayants Thursday, May 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eleonora Babayants
GxP-GMP and its Consequences for Information Technology Systems
There are GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements.

Angela Bazigos Thursday, May 10, 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.

David Nettleton Thursday, May 10, 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 Compliance
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.

Lamont M. Fulton Friday, May 11, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Lamont M. Fulton
Guidelines, Formats, and Checklist for Submitting a Qualified ANDA (Abbreviated New Drug Application) to the FDA, OGD (Office of Generic drugs)
Twenty-five years ago, Congress enacted the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act1 (hereinafter "Hatch- Waxman")-the cornerstone for competition between brand and generic pharmaceutical companies.

Mike Thomas Monday, May 14, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Mike Thomas
Get Organised with Microsoft Outlook
If you're like millions of other business professionals, you probably use Microsoft Outlook every day to manage your email, calendar and to do's. It's available for Windows, Mac, mobile and there's even a web version. So there's no excuse not to be organised. Or so the theory goes. The reality is email overload, missed deadlines and calendars so full you have no room to breathe.

Dr. Ludwig Huber Monday, May 14, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Carolyn Troiano Monday, May 14, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Customs - Trade Partnership Against Terrorism (C-TPAT)
The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP). It is intended to improve the security of supply chains of private enterprises against the threat of terrorism.

Susanne Manz Monday, May 14, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 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.

John E Lincoln Tuesday, May 15, 2018
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.

Teri C. Soli Tuesday, May 15, 2018
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?

Dennis Taylor Wednesday, May 16, 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.

Steven S. Kuwahara Wednesday, May 16, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Steven S. Kuwahara
GMP Expectations for Products Used in Early Phase IND Studies
FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Robert E. Davis Wednesday, May 16, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Robert E. Davis
Assuring IT Regulatory Compliance
The concept of industrial compliance with applicable laws and regulations deals with obeying the statutory requirements to which the entity is subject. Compliance infers acceptance. Societal expected behavior acceptance requires value(s) conformity to established norms. Conformance to government enforced rules is the ultimate goal for most societies to ensure a common baseline of legally acceptable entity behavior, whether laws or regulations apply to individuals or groups.

Angela Bazigos Thursday, May 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3 Hours Boot Camp on FDA's Guidance: Medical Device Recalls
Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from devices that present a risk of injury or gross deception or are otherwise defective.

Richard Chamberlain Thursday, May 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Richard Chamberlain
What is Computer Systems Validation?
The course will cover the history of Computer Systems Validation from the late 1970's to today. We will start with Process Validation and Qualification. Validation played a role in the GXPs, all three. The GMP was the furthest along, followed by the Laboratory practices, and finally the Clinical Research areas.

George Gasparis Friday, May 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: George Gasparis
Investigator Reporting Responsibilities: AEs, Unanticipated Problems, Modifications, and Deviations
This webinar will provide a comprehensive review of FDA and Office for Human Research Protections (OHRP) reporting requirements for investigators. A comparison will be provided for the AE reporting requirements for drugs and devices.

Laura Brown Friday, May 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
CAPA Systems for Compliance
This course will be ideal for you to learn how to improve industry procedures and processes and how to implement and document an effective CAPA quality system.

Angela Bazigos Friday, May 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3 Hours Boot Camp on Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds
This presentation uses the latest FDA thinking and guidance documents to assist you in re-establishing those requirements that need to be fulfilled in the evaluation for microbial methods used in your testing laboratories. It also re-establishes performance evaluation (verification & validation) criteria, necessary for the use of commercially-available diagnostic test kits and platforms.

Sheldon Primus Friday, May 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Sheldon Primus
Manufacturing Safety: What you don't Know can Harm you
In this webinar, we will explore the hazards related to the manufacturing facility on many fronts. To understand the plant work environment as it relates to safety, the employer must consider what the equipment the workers are exposed to on a daily basis.

Robert J. Russell Tuesday, May 22, 2018
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 Tuesday, May 22, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
Implementation and Management of GMP Data Integrity
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry's responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.

Ginette Collazo Wednesday, May 23, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Supervising a Human Error Free Environment: You can do a Lot More than you Think
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

John Ryan Wednesday, May 23, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John Ryan
Building your Company FDA FSMA Preventive Control Food Safety Plan
All food facilities registered with the United States Food and Drug Administration (FDA) must comply with the requirements under the Food Safety Modernization Act (FSMA) to develop and implement a Preventive Control Food Safety Plan that includes a Food Defense Plan. The plan must also include a hazard analysis, allergen analysis, factory profile, recall plan, supply chain controls, process preventive controls, sanitation preventive controls and other items.

Peggy Berry Wednesday, May 23, 2018
11:30 AM PDT | 02:30 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Peggy Berry
Setting Specifications for Drug Substances and Drug Products
This program will teach you to set specifications for drug substance and drug product,including use of release test data, long term stability, accelerated stability and special stability studies. The webinar will also cover changing specifications during lifecycle management.

John E Lincoln Wednesday, May 23, 2018
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".

Roger Cowan Thursday, May 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Roger Cowan
GMP Environmental Monitoring in Pharmaceutical Clean Rooms
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.

Edwin Waldbusser Thursday, May 24, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Heath Suddleson Thursday, May 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Heath Suddleson
Networking for Fun and Profit
Most people lack the basic networking skills necessary to do their jobs properly. These networking skills help us in many areas of our jobs.

Shep Bentley Friday, May 25, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Shep Bentley
FDA Review of 510(k)s - How to Speed the Process
Every person or company who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).

Charles H. Paul Friday, May 25, 2018
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.

Thomas Nollner Tuesday, May 29, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Thomas Nollner
How Should you Prepare for a BSA Regulatory Examination
The BSA examination process is intended to assess the effectiveness of a financial institution's BSA compliance program and the institution's compliance with the regulatory requirements related to the BSA. A regulatory examination should cover a review of the risk management process, an analysis of the institution's independent testing system, a detailed and thorough of the BSA compliance program, transaction testing where appropriate, a specific review of the suspicious activity identification, monitoring, and reporting systems, and a review of IT systems used in the BSA process.

Roger Cowan Tuesday, May 29, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Roger Cowan
Sterile Filtration of Pharmaceutical Products
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement.

Jose Mora Wednesday, May 30, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles on Lean Documents and Lean Configuration
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Susanne Manz Wednesday, May 30, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 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.

Michael Aust Thursday, May 31, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Michael Aust
Understanding the Complexity of OSHA's Recordkeeping Regulation
In this webinar program, you will learn how to identify and comply with the compliance schedule and forthcoming changes of the compliance schedule pertaining to online electronic submission.

George Gasparis Tuesday, June 5, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: George Gasparis
Criteria for IRB Approval - Essential Training for IRB Members and Staff
Institutions/organizations that are responsible for the operation of the IRB have the responsibility for ensuring that its IRB administrators/staff and IRB members have adequate training and knowledge to review the research it approves. With turnover of IRB staff and IRB members, this responsibility must be constantly addressed.

Angela Bazigos Tuesday, June 5, 2018
10:00 AM PDT | 01:00 PM EDT
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.

Larry Spears Wednesday, June 6, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Larry Spears
FDA Export Certificates for Medical Devices
Companies need to stay internationally competitive and this webinar on export certificates provides a key link for entry to markets around the globe. This webinar will explore the export approval and certification process in the U.S. It will include guidance on preparing applications and obtaining FDA's certification that specific products identified for export meet U.S. regulatory requirements. All of this will be valuable in obtaining broader access to global markets.

Michael Aust Thursday, June 7, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Michael Aust
The Safety Maturity Curve - Where does your Organization Stand?
This webinar will focus on evolving a zero incident workplace culture within any organization,rather an existing or not.We will discuss the pro's and con's of a implementing a zero incident workplace culture and describe how to determine if you are doing it right.

Eleonora Babayants Thursday, June 7, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eleonora Babayants
Corrective and Preventive Action (CAPA) per FDA Requirements
CAPA - Corrective and Preventive Action plan. CAPA is a concept within Good Manufacturing Practice (GMP). It is required for FDA compliance in case of specification situations or other deviations. CAPA is part of the overall quality management system (QMS).

Danielle DeLucy Thursday, June 7, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
Successful Supplier Audits
When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier's acceptability is to audit its operation.

Shep Bentley Friday, June 8, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Shep Bentley
Risk Management Simplified
At its most basic, risk management is the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk. The International Standards Organization (ISO) Technical Committee 210 (ISO/TC 210), Quality management and corresponding general aspects for medical devices, was formed in 1994, and the group published the first edition of the ISO 14971 risk management standard for medical devices in 1998.

Laura Brown Friday, June 8, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
Oversight of CROs-Vendors-CMOs
It is essential for industry to employ efficient and accurate strategies for monitoring outsourced projects to minimize the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, and quality monitoring and risk minimization when outsourcing activities in GXP areas to remain compliant.

David Nettleton Friday, June 8, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: David Nettleton
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This webinar details the regulation and how it applies to computerized systems.

Michael Esposito Monday, June 11, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Michael Esposito
Introduction to Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

Roger Cowan Tuesday, June 12, 2018
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.

Carolyn Troiano Tuesday, June 12, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. 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.

Angela Bazigos Wednesday, June 13, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Comply with 21 CFR 11 Requirements for Electronic Medical Records
The principles outlined in this webinar can be used for computerized systems that contain any data that are relied on by an applicant in support of a marketing application, including computerized laboratory information management systems that capture analytical results of tests conducted during a clinical trial. For example, the recommendations in this webinar would apply to computerized systems that create source documents (electronic records) that satisfy the requirements in 21 CFR 312.62(b) and 812.140(b), such as case histories.

Robert J. Russell Wednesday, June 13, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Robert J. Russell
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Jose Mora Wednesday, June 13, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
Through the Eyes of an Auditor
Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally, an auditor has personal experiences of what a state of control looks like and has visited sufficient places to know what to look for.

Edwin Waldbusser Thursday, June 14, 2018
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 Thursday, June 14, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Responding to FDA 483s and FDA Warning Letters
Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.

Jose Mora Wednesday, June 20, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
Chipping Away at Constraints - Practical Tips to Improve your Manufacturing Operations
Many times your manufacturing operation seems very busy yet the throughput of the entire line is poor.We often confuse busy and efficient with productive. This webinar is based upon real-life examples and how simple techniques were used to improve overall productivity without the need to spend weeks performing complex modeling and analysis.

John Ryan Tuesday, June 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Ryan
Food Fraud in the Organic Industry
The U.S. Department of Agriculture's Office of the Inspector General reported recently that they have failed to review required documents for products labeled as "organic". This finding and report means a lack of controls at U.S. borders increases the likelihood that nonorganic products are entering the U.S. under "organic" labels.

John E Lincoln Wednesday, June 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John E Lincoln
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

Jose Mora Tuesday, July 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
Process Validation Requirements & Compliance Strategies
This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.

Charles H. Paul Thursday, July 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
Working Effectively with Customers & Suppliers
This webinar will begin by defining and discussing why the customer-supplier relationship is important and how you define those relationships. We look at the relationship structure as a process comprising a series of inputs and outputs which we define. How the relationship impacts customer satisfaction is paramount and critical to organizational success.

Jose Mora Thursday, July 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Jose Mora
Effective Design of Experiments (DOE) Strategies
This DOE (Design of experiments) training focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.

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