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Upcoming Events

Compliance4all

Latest Guidelines for Combination Products Registration - 2017

Fremont, CA
Overview:During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products.

Overlap between Engineering and Psychology - 2017

Fremont, CA
Overview:This course will show how psychological factors enter into the engineering profession. Many aspects of the engineering profession are nontechnical such as balancing "green" practices with an effective cost structu... read more

Automating Excel - How to edit an Existing Macro - 2017

Fremont, CA
Overview:VBA is the programming language that is built in to Excel (and the other applications in the MS Office Suite).VBA is used to automate tasks that would otherwise have to be performed manually by pressing keys and s... read more

Statistical Concepts of Process Validation - 2017

Fremont, CA
Overview:Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to perform an effective process validation.

Excel - How to Create Resilient and Practical Budget Spreadsheets - 2017

Fremont, CA
Overview:David shares a wide range of helpful techniques, including how to separate inputs from calculations, streamline formula writing, preserve key formulas, and create both operating and cash flow budgets.

Food - Current and Future Safety Regulations - 2017

Fremont, CA
Overview:Importers of food products intended for introduction and consumption in the United States through international commerce are responsible for ensuring that the products are safe, sanitary, wholesome, and labeled ac... read more

ACH Fraud - Detection and Prevention - 2017

Fremont, CA
Overview:  The types of internal processes and controls necessary vary by industry and organization size. This course reviews a wide variety of options and recommendations to assist attendees with developing their own inte... read more

Cyber Issues in Your Business Continuity Planning - 2017

Fremont, CA
Overview:  This webinar training will discuss how to create, test and implement an effective cyber Incident program to counter cyber threat and malware attacks.

Successful Supplier Audits - 2017

Fremont, CA
Overview:One of the tools at your disposal to verify the supplier's acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge of supplier audits.

FDA-Regulated Environment Development Team - 2017

Fremont, CA
Overview:  The Agile approach is well established in other industries adoption of Agile in medical device development has been increasing in the past five years.

FDA and ISO Compliance Personnel Training - 2017

Fremont, CA
Overview:  To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them.

Laboratory Accreditation -Getting There is Just the Beginning - 2017

Fremont, CA
Overview:  Accreditation is not a guarantee of analytical competency. Getting accredited is just the beginning. The journey begins with defining the laboratory's operating principals and policies.

Process Validation - Statistical Process Control - 2017

Fremont, CA
Overview:  Process knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Record for each critical step of the process operation and the overall p... read more

Expectations of Regulatory & Validation Master Planning - 2017

Fremont, CA
Overview:  This presentation will cover the importance of master planning. The FDA and other regulatory bodies expect these to be among the Quality System documentation.

Aseptic Technique Understanding and Cleanroom Behavior - 2017

Fremont, CA
Overview:  Compounding sterile products are made utilizing aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination.

Latest FDA Changes to the Process Bullet Proof 510k - 2017

Fremont, CA
Overview:  The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.

Control Change in Medical Device Engineering - 2017

Fremont, CA
Overview:  This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming.

Cyber Attacks, Beyond Disaster Recovery - 2017

Fremont, CA
Overview:Cyber-attacks and breaches dominate the media and are a significant focus of the government. Businesses and financial institutions are faced with the grim reality that a cyber-attack is inevitable. It's not a matt... read more

Effective Supplier Qualification Program - 2017

Fremont, CA
Overview:FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct. FDA will deal with your company in case of product failure, especially as related to end user or patient safety ... read more

Achieving Compliance Excellence - 2017

Fremont, CA
Overview:We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organization.

Validation Program to a Building from Top to Bottom - 2017

Fremont, CA
Overview:Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program.

FDA Inspection and Respond to 483 & How to Prepare them - 2017

Fremont, CA
Overview:In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection.

CAPA within a Device Quality System - 2017

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.

Environmental Monitoring Program at FDA Regulations - 2017

Fremont, CA
Overview:  Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monit... read more

Laboratory-Developed Tests - Medical devices 2017

Fremont, CA
Overview:This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current si... read more

ISO 14971 Hazard Analysis at Medical Device - 2017

Fremont, CA
Overview:  The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.

Letters of Credit are issued under the Customs and Practice 2017

Fremont, CA
Overview:Letters of Credit are the primary instruments for assuring payment of goods sold internationally. Letters of Credit are issued under the Uniform Customs and Practice standard and can be negotiated by over 30,000 b... read more

Medical Devices for Risk Management Techniques 2017

Fremont, CA
Overview:This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

Excel Methods - FDA Device Regulations - 2017

Fremont, CA
Overview:FDA regulations cover both the use of workbooks and the creation of electronic records device manufacturers must understand these regulations and their application. The presentation begins with Excel methods to he... read more

Clinical Trials - Medical Device FDA's Program 2017

Fremont, CA
Overview:The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product.
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Past Events

ICH Q11- API Manufacturing - 2017

ICH Q11- API Manufacturing - 2017

Fremont, CA
Overview:This webinar will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application. Why should you Attend:This presentation is presented i...
Thursday, June 22 2017 10:00 AM 11:30 AM

Annual Product Quality Review - 2017

Annual Product Quality Review - 2017

Fremont, CA
Overview:Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. Why should ...
Wednesday, June 21 2017 10:00 AM 11:00 AM

FDA offers New Import Program for 2017

FDA offers New Import Program for 2017

Fremont, CA
Overview:FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Why should you Attend:The new import entry filing requi...
Tuesday, June 20 2017 10:00 AM 11:00 AM

CAPA System and Uses of CAPA Data - 2017

CAPA System and Uses of CAPA Data - 2017

Fremont, CA
Overview:This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Areas Covered in the Session:Elements of a cross-procedural CAPA programApplications of CAPACAPA Data, and best practices for its useApplication of risk m...
Monday, June 19 2017 10:00 AM 11:00 AM

Finance - How to Interpret Nonfinancial Professionals - 2017

Finance - How to Interpret Nonfinancial Professionals - 2017

Fremont, CA
Overview:This program covers a general overview of accounting and financial information and how to interpret reports so that you can make the best decisions in your role as a manager in your organization. Why should you Attend:No matter the title you hold or how brilliant your idea is, it usuall...
Thursday, June 15 2017 10:00 AM 11:30 AM

Billing Medicare For DME - How to Get the Proper Licensure - 2017

Billing Medicare For DME - How to Get the Proper Licensure - 2017

Fremont, CA
Overview:Learn how to provide your Medicare patients with Durable Medical Equipment to maximize patient clinical outcomes while developing a great revenue stream. Why should you Attend:Learn to develop a large new revenue stream while protecting your senior patients from unnecessary surgeries, i...
Wednesday, June 14 2017 10:00 AM 11:00 AM

Audit - How to Improve Your Internal Audit program - 2017

Audit - How to Improve Your Internal Audit program - 2017

Fremont, CA
Overview:This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. Why should you Attend:Continuous Improvement starts with awareness of issues and opportunit...
Tuesday, June 13 2017 10:00 AM 11:30 AM

EU Clinical Trial regulation - 2017

EU Clinical Trial regulation - 2017

Fremont, CA
Overview:Transition between Directive 2001/20/EC and Regulation EU No 536/2014 Until the Clinical Trials Regulation EU No will become applicable, all clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive 2001/20/EC. Why sho...
Monday, June 12 2017 10:00 AM 11:00 AM

Challenges to relevant Financial Statements - 2017

Challenges to relevant Financial Statements - 2017

Fremont, CA
Overview:This course will cover both the telecommunication and technology industries and pinpoint how company operations can be improved. Why should you Attend:With my LIFA certification and 15 years in international finance topics such as IFRS, GAAP, and international accounting in the semicond...
Thursday, June 8 2017 10:00 AM 11:30 AM

Software Validation Program That will Satisfy FDA Requirements - 2017

Software Validation Program That will Satisfy FDA Requirements - 2017

Fremont, CA
Overview:This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. Why should you Attend:Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements,an...
Thursday, June 8 2017 10:00 AM 11:00 AM
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