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Upcoming Events

Compliance4all

Project Management for Non-Project Managers 2018

Fremont, CA
Overview: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 ... read more

Historical Perspective of the Part 11 Regulation

Fremont, CA
Overview:This presentation will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements,electronic records requirements, and electronic signatures requirements.

Best Practices to Support FDA Computer System Validation

Fremont, CA
Overview:We will cover the importance of maintaining the documentation from every computer system validation effort in a "current" state. The system must be maintained in a validated state throughout its entire life cycle,... read more

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... read more

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 C... read more

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, im... read more

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.

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)

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.

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 6236... read more

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
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Past Events

Networking for Fun and Profit

Networking for Fun and Profit

Fremont, CA
Overview:Most people lack the basic networking skills necessary to do their jobs properly. These networking skills help us in many areas of our jobs. Why should you Attend:Worried that you could be passed up for that promotion because someone else in the office has all the right connections? Are...
Thursday, May 24 2018 10:00 AM 11:30 AM

Drug Substances and Drug Products - Specifications

Drug Substances and Drug Products - Specifications

Fremont, CA
Overview:This program will teach you to set specificatons for drug substance and drug product,including use of release test data, long term stability, accelerated stability and special stability studies.  Why should you Attend:Learn the recommendations of ICH for using testing and stability data...
Wednesday, May 23 2018 10:00 AM 11:30 AM

FDA FSMA Preventive Control Food Safety Plan

FDA FSMA Preventive Control Food Safety Plan

Fremont, CA
Overview: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.  Why should you Attend:This "how to"webinar will lead you and your team through two planning...
Wednesday, May 23 2018 10:00 AM 11:30 AM

Investigator Reporting Responsibilities - OHRP

Investigator Reporting Responsibilities - OHRP

Fremont, CA
Overview:The webinar will also discuss how to make determinations of whether an adverse event is probably related, possibly related, or possibly/probably not related to a drug or device.  Why should you Attend:Are you being cited for failure to report safety information, changes to the research ...
Friday, May 18 2018 10:00 AM 11:00 AM

Manufacturing Safety - What you don't Know can Harm you

Manufacturing Safety - What you don't Know can Harm you

Fremont, CA
Overview: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. Why should you Attend:Manufactu...
Friday, May 18 2018 10:00 AM 11:00 AM

Assuring IT Regulatory Compliance

Assuring IT Regulatory Compliance

Fremont, CA
Overview: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. Why should you A...
Wednesday, May 16 2018 10:00 AM 11:00 AM

Expectations for Products Used in Early Phase

Expectations for Products Used in Early Phase

Fremont, CA
Overview:This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. Areas Covered in the Session:Discussion of the elements found in the guidance document for Phase 1 materialWhat to do at r...
Wednesday, May 16 2018 10:00 AM 11:15 AM

C-TPAT - Trade Partnership Against Terrorism 2018

C-TPAT - Trade Partnership Against Terrorism 2018

Fremont, CA
Overview: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. Why should you Attend:Th...
Monday, May 14 2018 10:00 AM 11:30 AM

High Cost of Bad Management

High Cost of Bad Management

Fremont, CA
Overview:The first cost to the organization is turnover in staff. It is often said that people join companies and leave managers. Bad managers will drive the best employees away, while only those employees who have fewer marketable skills will remain. Why should you Attend:Every bad leader has t...
Wednesday, May 9 2018 10:00 AM 11:30 AM

Fundamentals of Risk Management in Clinical Research 2018

Fundamentals of Risk Management in Clinical Research 2018

Fremont, CA
Overview:The premise behind RBQM is that monitoring quality can be improved by leveraging existing data intelligence. This, in turn, calls for more robust quality assurance (QA) systems focused and efficient resource utilization and allocation at the clinical site level. Why should you Attend:Pr...
Friday, May 4 2018 10:00 AM 11:00 AM
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