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Upcoming Events

Compliance4all

What's Changing for Life Science Product License Holders (BREXIT)

Fremont, CA
Overview: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 ... read more

Computer System Validation 2018 Fundamentals

Fremont, CA
Overview: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). V... read more

Managing and Controlling the Project - Project Management

Fremont, CA
Overview:Successful projects require continued care and management to ensure that the project follows the plans correctly and, as a result, leads to the desired results. When unexpected situations occur, you must react pro... read more

Audit Executive - Leading the Internal [Audit Function]

Fremont, CA
Overview: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.

Validation Sampling Plans for Process Validation [Latest]

Fremont, CA
Overview:Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validationHow to identify when sampling plans for other properties are ... read more

R2 Addendum- Changes Impacting Sponsors-CRO-Sites

Fremont, CA
Overview:The revised guidelines are entitled "Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2)." The ICH steering committee comprised of representatives from the pharmaceutical industry and th... read more

Mastering Excel [Pivot Tables] in Advanced Technology

Fremont, CA
Overview:You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Advanced Formulas & [Functions in Excel] 2018

Fremont, CA
Overview: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... read more

Business Continuity Planning for [Computer Systems] Operations

Fremont, CA
Overview: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... read more

Record Keeping Best Practices [FDA and EMA] Documentation

Fremont, CA
Overview: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 ... read more

That your Supplier can meet all your Expectations

Fremont, CA
Overview: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 the oper... read more

Which are Compliant for Inspections for a [GXP Compliance]

Fremont, CA
Overview:This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.

Ensuring Medical Devices are safe and [Effective] for Intended Uses

Fremont, CA
Overview:You'll learn techniques that can help you identify hazards and potential harms. You'll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products.

Data Integrity in Clinical Trials in [Latest methods]

Fremont, CA
Overview: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.

Control-Analysis Instrumentation used in PAT Continuous [Manufacturing]

Fremont, CA
Overview:How to build the PAT/CM team and set goals, budgets, and make the change-overs smoothly and efficiently.

Latest Excel Formulas and Functions in [2018]

Fremont, CA
Overview:Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

OOS Test Results and Completing [Robust] Investigations

Fremont, CA
Overview: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... read more
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Past Events

Risk Based Internal Auditing - Establishing the Methodology

Risk Based Internal Auditing - Establishing the Methodology

Fremont, CA
Overview: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. Why should you Attend:The Institute of Internal Auditors defines risk based internal auditing (RBIA) as a methodology tha...
Wednesday, October 17 2018 10:00 AM 11:30 AM

Advanced Mastering Macros in Microsoft Excel

Advanced Mastering Macros in Microsoft Excel

Fremont, CA
Overview:Don't be afraid of macros - learn how to create and use them. When you find yourself repeating actions in Excel - whether it's a five-step sequence you use when formatting a certain cell type or the 30 steps you use when you sort, filter, and print multiple worksheets once a week, the po...
Monday, October 15 2018 10:00 AM 11:00 AM

Good Documentation Guideline (Chapter 1029 USP)

Good Documentation Guideline (Chapter 1029 USP)

Fremont, CA
Overview:Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system. Why should you Attend:GDP is part of GMP and if you know it by heart, it prevents a lot of wrongdoings and minimizes the chanc...
Friday, October 12 2018 10:00 AM 11:00 AM

What you need to know to Meet FDA and International Quality Standards

What you need to know to Meet FDA and International Quality Standards

Fremont, CA
Overview:This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality. Why should you Attend:Compressed air is often overlooked as a potential source of clean room and product conta...
Friday, October 12 2018 10:00 AM 11:00 AM

FDA New Draft Guidance on (Software) and Device Changes 510k

FDA New Draft Guidance on (Software) and Device Changes 510k

Fremont, CA
Overview:A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Why should you Attend:This includes any major...
Friday, October 12 2018 9:00 AM 12:00 PM

Information Technology - Control Procedures in Regulated Industries

Information Technology - Control Procedures in Regulated Industries

Fremont, CA
Overview:In this webinar, change control procedures within quality management systems (QMS) for documentation and information technology systems will be discussed. Why should you Attend:GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical...
Friday, October 12 2018 7:00 AM 8:30 AM

Complying with the Revenue Recognition Standard

Complying with the Revenue Recognition Standard

Fremont, CA
Overview:This FASB revenue recognition standard webinar will discuss the various steps involved in this standard and also the technical guidance to prepare a revenue recognition model. Why should you Attend:This course is designed to provide an overview of the technical guidance and outline the ...
Wednesday, October 10 2018 10:00 AM 11:30 AM

Updated CE Marking Process & ISO Expectations

Updated CE Marking Process & ISO Expectations

Fremont, CA
Overview:It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implemen...
Tuesday, October 9 2018 10:00 AM 11:30 AM

Medical Device Hazard Analysis - Risk Management

Medical Device Hazard Analysis - Risk Management

Fremont, CA
Overview:This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools. Why should you Attend:FDA expects th...
Tuesday, October 2 2018 10:00 AM 11:00 AM

Advanced PowerPoint Tips and Tricks 2018

Advanced PowerPoint Tips and Tricks 2018

Fremont, CA
Overview:This webinar will show you the basics of getting started with PowerPoint, and how to start to build impactful presentations. You will learn how to build a presentation from scratch, how to easily add a professional look and feel in just few clicks, how to add text, bullet lists, pictures...
Friday, September 28 2018 10:00 AM 11:15 AM
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