0
FOLLOWING
7
FOLLOWERS
SEMINAR
DEC
04
8:30 AM
120 N Los Angeles St, Los Angeles, CA 90012, USA
Overview: We will share the regulatory compliance issues and best practices for collecting Forms W-9 and W-8, performing TIN matching, your information reporting requirements, if and when back-up withholding must begin and the withholding rates, efficient handling of CP-2100 / B-Notices, responding to IRS notices of proposed penalties, reporting to non-resident aliens, and compliance with the Foreign Account Tax Compliance Act (FATCA). Why should you attend? In addition, how do you determine whether you can accept a W-9 from someone or you must request a W-8 instead? What if you send them...
CONFERENCE
NOV
13
9:00 AM
333 Orchard Rd, Singapore 238867
Course "Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic...
SEMINAR
OCT
09
9:00 AM
Las Vegas, NV, USA
Summary: We will consider the following: The Design Control requirements of the CGMPs, 21 CFR 820.30 The Design History File - documenting Product Design Control and its nine elements The Device Master Record and the Device History Record The EU’s Medical Device Directive The "Essential Requirements"; and their documentation The remaining elements of a Technical File / Design Dossier Trends Two attendee projects Learning Objectives: This seminar / workshop will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivative documents, the DMR...
SEMINAR
SEP
29
9:00 AM
Hohenbühlstrasse 10, 8152 Opfikon, Switzerland
2-day In-person Seminar on “Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors” in Switzerland from GlobalCompliancePanel Detailed Description: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analysed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of...
SEMINAR
SEP
25
9:00 AM
488 George St, Sydney NSW 2000, Australia
Detailed Description: Discription: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analysed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of...
SEMINAR
SEP
11
9:00 AM
Melbourne VIC, Australia
Overview: This course is designed for people who are growing in their knowledge of pharmaceutical quality control practices and regulations. It will be a "how to" course where the instructor will explain the reasoning as well as the procedures that should be used to meet the various requirements of the pharmaceutical QC laboratory. The instructor will present different areas of work with a "how to" approach so that the seminar participant can see how the subject matter applies to the participant's work either now or in the future. In addition to discussing the particular subjects he will...
SEMINAR
SEP
04
9:00 AM
2950 S River Rd, Des Plaines, IL 60018, USA
Overview: This course provides an overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements, including both voluntary and mandatory standards and directives, and progressing to in-depth analyses of market specific requirements, the course provides the student with resources to meet the regulatory requirements for the largest world markets. Country-specific regulatory requirements for Canada, EU, and US are included. Why should you attend? This course provides a basic description of global regulatory strategy for medical...
SEMINAR
SEP
04
9:00 AM
2950 S River Rd, Des Plaines, IL 60018, USA
Overview: The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA"). How the FDA will deal with such advanced communication technology that can go "viral" and just as quickly disappear is the question that the industry is eager to have answered. The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the information is not false or misleading. The FDA has for decades regulated...
Dr Steven S. Kuwahara President of GlobalCompliancePanel
SEMINAR
AUG
14
8:30 AM
Hohenbühlstrasse 10, 8152 Opfikon, Switzerland
Overview: Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the...
CONFERENCE
AUG
04
8:30 AM
488 George St, Sydney NSW 2000, Australia
Overview: This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm. How well do you understand how you can utilize statistics to address the ICH guidelines? Most organizations have programs and procedures but fall short in the implementation of the tool and techniques used to apply the appropriate statistical tools. This 2 day hands-on workshop explores the unique...
SEMINAR
AUG
07
8:30 AM
333 Orchard Rd, Singapore 238867
Overview: Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. And of course, with statistics, practice makes perfect. During this two-day HIGHLY interactive training program, participants will be given the opportunity to apply statistics learned to real-world example data sets! The program begins by...
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