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Upcoming Events

Compliance4all

When Conducting cGMP Regulatory Inspections 2018

Fremont, CA
Overview: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 inspe... read more

CAPA for Medical Devices 2018

Fremont, CA
Overview: 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. In this 3-hour webinar, you'll learn how to strea... read more

Revolutionary Change in FDA Software Regulation

Fremont, CA
Overview:It is not about giving an OK to products, it is about trusting the manufacturer to do the right thing. Overall, your regulatory approach to software regulation needs to ease up and reap the benefits where they app... read more

What are the Tools required for Human Error Reduction

Fremont, CA
Overview:This course offers practical approaches and tools to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

What you Need to Know to Prepare FDA Inspection

Fremont, CA
Overview:Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you mana... read more

Best Practices for Foundational (Employee) Success 2018

Fremont, CA
Overview:FDA expectations provide some of the framework regarding types and frequency of training, there are decisions that the company will need to make in light of its evaluation of how to best achieve compliance for its... read more

Compliance for Electronic Records and Signatures (21 CFR Part 11)

Fremont, CA
Overview:Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webi... read more

Improving Compliance and your Company's Bottom Line (MedicalDevice Cybersecurity)

Fremont, CA
Overview:This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats. Cybersecurity is a serious... read more

Managing and Examining Travel and Entertainment (Expense 2018)

Fremont, CA
Overview:This course provides insight on how to bring control and intelligent management to your company's T&E process.We evaluate how to bring people, process, technology, strategy and information together to provide the ... read more

Project Management for Non-Project Managers (2018 Estimating Resource Needs)

Fremont, CA
Overview:This webinar will explore how to most effectively apply both the human and non-human resources to project tasks that you require to achieve your project's outcome.Once you have identified and allocated your availa... read more

Compliance for Risk Based Approaches for (Clinical Trials 2018)

Fremont, CA
Overview:FDA and EMA have communicated their expectations for trial oversight/ monitoring, monitoring systems, and investigative site oversight. These are described in the FDA Guidance Oversight of Clinical Investigations:... read more

cGMPs in the Quality Control Laboratory (Medical 2018)

Fremont, CA
Overview:In this webinar we will apply one aspect of this proactive approach, the review regulatory requirements and analysis of 483 and Warning Letter observations to determine if similar observations could be made in the... read more

Quality Agreements Made Easy (Advanced 2018)

Fremont, CA
Overview:The requirements for the assurance of quality within networks and circles of entities whose responsibilities are increasing specialized present an especially vexing challenge to the managements of each of these or... read more

FDA continues to enforce through its new 21 CFR Part 11 inspection

Fremont, CA
Overview:The webinar will have the answers. In addition, using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for troub... read more

Assessing and Planning for Risk (Latest 2018)

Fremont, CA
Overview:Project risk is greater the longer your project lasts, the longer the time between preparing your project plan and starting the work, the less experience you, your team members, or your organization may have with ... read more

Controlling Human Error in the Manufacturing Floor (New 2018)

Fremont, CA
Overview:This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

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 professiona... read more
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Past Events

2018 Calibrating the Human Gage

2018 Calibrating the Human Gage

Fremont, CA
Overview:  A review of basic AAA analysis. Will cover the 3 basic types of agreements: Agreement with oneself, Agreement to a peer, Agreement to the standard. Both the "Statistical AAA" and the Kappa value will be reviewed. Confidence levels for the result bands will also be reviewed. Incorporat...
Thursday, August 16 2018 10:00 AM 11:00 AM

Verification vs Validation-Product, Equipment and QMS Software

Verification vs Validation-Product, Equipment and QMS Software

Fremont, CA
Overview:You will learn What do the U.S. FDA and EU Expect for Verification and Validation, Actions and documentation to meet U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements, ISO 14971 and IEC 62366 considerations, as appropriate. Why should you Attend:The FDA / ICH Q-se...
Wednesday, August 15 2018 8:00 AM 11:00 AM

Design Control is Critical to Product Quality

Design Control is Critical to Product Quality

Fremont, CA
Overview:This 90-minute webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. Why should you Attend:Design Control is not only a regulatory requirement, it ...
Tuesday, August 14 2018 10:00 AM 11:30 AM

Cloud Software Applications for 21 CFR Part 11

Cloud Software Applications for 21 CFR Part 11

Fremont, CA
Overview:This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity. Areas Covered in the Session:Which data and systems are subject to Part 11What Part 11 means to you, not just what it says in the regulationAvoi...
Tuesday, August 14 2018 9:00 AM 12:00 PM

When to Submit a 510(k) for a Change to an Existing Device

When to Submit a 510(k) for a Change to an Existing Device

Fremont, CA
Overview: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) Why should you Attend:This presentation uses the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the ...
Tuesday, August 14 2018 9:00 AM 12:00 PM

Validation Under Good Laboratory Practices

Validation Under Good Laboratory Practices

Fremont, CA
Overview:This webinar will discuss the best practices of analytical method validation, including components of a validation, how to include critical reagents comparison, selectivity experiments, assessment of stability, importance of communication between the development and the validation labs a...
Monday, August 13 2018 10:00 AM 11:00 AM

Spreadsheets for 21 CFR 11 Compliance Advanced

Spreadsheets for 21 CFR 11 Compliance Advanced

Fremont, CA
Overview: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. Areas Covered in the Session:Requirements for Excel Spre...
Friday, August 10 2018 10:00 AM 11:30 AM

Understanding the Requirements of SSAE18

Understanding the Requirements of SSAE18

Fremont, CA
Overview:  This course will help you if your organization has the need to obtain or provide a SOC (Service Organization Control) report or if you wonder what changes the new SSAE 18 standard will bring to the process. SSAE 18 is effective for SOC report opinions dated on or after May 1, 2017 and...
Friday, August 10 2018 10:00 AM 11:30 AM

How to Identify and Eliminate Multiple Root Causes

How to Identify and Eliminate Multiple Root Causes

Fremont, CA
Overview:  Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability. Why should you Attend: Traditi...
Wednesday, August 8 2018 10:00 AM 11:00 AM

How to validate an analytical method under the GLP requirements

How to validate an analytical method under the GLP requirements

Fremont, CA
Overview:  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. Wh...
Wednesday, August 8 2018 10:00 AM 11:30 AM
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