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Upcoming Events

Compliance4all

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

Quality in Home Food Delivery 2018

Fremont, CA
Overview: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 reache... read more

How to Comply with 21 CFR 11 Requirements

Fremont, CA
Overview: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.

GMP Regulations and How it Apply to Analytical Laboratories

Fremont, CA
Overview: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... read more

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 utili... read more

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 m... read more

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 pri... read more

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 acce... read more

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.

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.

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 th... read more

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.

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.

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.
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Past Events

Label Promotion of Drugs and Medical Devices

Label Promotion of Drugs and Medical Devices

Fremont, CA
Overview:This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA's decision on guidance documents. Why should you Attend:This class presents the latest FDA, industry & patient thinking to assist manufa...
Tuesday, April 24 2018 10:00 AM 1:00 PM

How a Quality and Lean Steering Committee can be Effectively Utilized

How a Quality and Lean Steering Committee can be Effectively Utilized

Fremont, CA
Overview:Attendees will observe the development of the key components of a steering committee. Several successful examples across various business types will be shared. Why should you Attend:This interactive and hands-on session takes participants through Steering Committee formation, implementa...
Friday, April 20 2018 10:00 AM 11:00 AM

Failure Modes - How to use these Kinds of Methods Together

Failure Modes - How to use these Kinds of Methods Together

Fremont, CA
Overview:This leads to an evaluation of the failure's effect on the product or process and measures to manage it. Often a criticality analysis augments the FMEA, creating an FMECA, to determine the priority order to address the failures. Why should you Attend:An FMEA is a versatile tool with man...
Wednesday, April 18 2018 10:00 AM 11:30 AM

ISO 62366 - How to Conduct a Human Factors

ISO 62366 - How to Conduct a Human Factors

Fremont, CA
Overview:This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. Why should you Attend:We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation...
Wednesday, April 18 2018 10:00 AM 11:00 AM

Understanding and Meeting your Regulatory & Processing Responsibilities

Understanding and Meeting your Regulatory & Processing Responsibilities

Fremont, CA
Overview:Why DMFs are important to you and your company , and How DMFs fit into FDA's regulatory processes for review of drug and biologic applications. Areas Covered in the Session:Why DMFs are important to you and your companyHow DMFs fit into FDA's regulatory processes for review of drug and ...
Monday, April 16 2018 10:00 AM 11:00 AM

Best Practices for Foundational Employee Success 2018

Best Practices for Foundational Employee Success 2018

Fremont, CA
Overview:Learn to interact with Human Resources to create a coordinated onboarding strategy, A successful onboarding strategy will combine the inputs of all these stakeholders and help create a consistent and well-understood process for the company. Why should you Attend:Onboarding in a GMP envi...
Wednesday, April 11 2018 10:00 AM 11:30 AM

ISO 13485 & ISO 9001 - How to Choose Which One to Implement

ISO 13485 & ISO 9001 - How to Choose Which One to Implement

Fremont, CA
Overview:This webinar will review the benefits of implementing a QMS, discuss the applicability of each standard to different types of organizations, and go on to explain the similarities, key differences, scope, and application of these standards to an organization. Why should you Attend:Qualit...
Tuesday, April 10 2018 10:00 AM 11:30 AM

Compliance for Electronic Records and Signatures 2018

Compliance for Electronic Records and Signatures 2018

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...
Friday, April 6 2018 10:00 AM 11:30 AM

Medical Device Single Audit Program Preparation

Medical Device Single Audit Program Preparation

Fremont, CA
Overview:The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. Why should you Attend:Today with a single audit, it is possible...
Friday, April 6 2018 10:00 AM 11:00 AM

Quality Audit According to Gxp-GMP Requirements 2018

Quality Audit According to Gxp-GMP Requirements 2018

Fremont, CA
Overview:GMP regulations describe required quality management system for production and testing of products in these regulated industries. The purpose of the GMP regulations is to ensure that a product is safe and meets its intended use. Why should you Attend:Learn about GxP/GMP regulations and ...
Friday, April 6 2018 10:00 AM 11:30 AM
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