World Conference Calendar

32676 Conferences

Conferences of Compliance4allrss


483 Covers a Broad Gradation of Problems

483 Covers a Broad Gradation of Problems

Location: , United States
Category: Education
Start Date: 10-25-2017
Overview: How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDAís review in your favor as it is well organized, succinct and provides proper documentation. Why You Should Attend: Your failure to understand and properly respond to a 483 issued to you at the conclusion of an FDA inspection may quickly lead to an administrative or a legal action that can have an immediate adverse effect on a firmís business. Areas Covered in the Session: What…
NIST Cybersecurity Framework For Computer Systems Validation

NIST Cybersecurity Framework For Computer Systems Validation

Location: , United States
Category: Health and Medicine
Start Date: 10-25-2017
Overview: Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information. Why Should you attend: Today's headlines are filled with instances of cyber attacks resulting in denial of service, data theft or compromise and even ransomware holding critical data hostage while demanding payment. Areas Covered in the Session: Understanding the NIST Framework Cybersecurity and Regulatory Considerations Risk Management and Cybersecurity Key Roles and Responsibilities Who Will Benefit: IT Managers, Directors, VPs, Chief Information Officers Quality Assurance/Quality Control…
Guidance on Software and Device Changes and the 510(k)

Guidance on Software and Device Changes and the 510(k)

Location: , United States
Category: Health and Medicine
Start Date: 10-30-2017
Overview: The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Why should you Attend: Anyone who is involved in software and device design, modification, manufacturing, quality testing and distribution should be aware of these changes and the impact on decision-making as to whether or not to prepare a new 510(k). The FDA provides flowcharts that guide the reader to the best decision, but some judgment is also required. Areas Covered in the Session: Medical Device changes Software Application changes for…
Principles of Food Extrusion Processing

Principles of Food Extrusion Processing

Location: , United States
Category: Health and Medicine
Start Date: 11-02-2017
Overview: This webinar will cover fundamental extrusion processing hardware as well as how that hardware is operated in order to produce the desired product. Both single and twin screw extruders and their differences in operating characteristics will be covered. Why should you Attend: Extrusion processing is a complex process and is regarded as a science with a healthy dose of art, typically requiring many years of practice to master. Areas Covered in the Session: Single and Twin Screw Extruders Screw Types Assembling a Screw Configuration Preconditioners Who Will Benefit: Product Developers Production Managers Production Operators Quality Assurance Technicians Speaker Profile:…
Requirements for Compliance Compounding Pharmacies

Requirements for Compliance Compounding Pharmacies

Location: , United States
Category: Education
Start Date: 11-02-2017
Overview: The course will be delivered in two modules. The first module will cover federal and state regulatory agencies governing compounding pharmacies and handling of hazardous drugs for sterile and nonsterile compounding according to USP 800. Why should you Attend: After the debacle of New England Compounding Center meningitis outbreak, the field of compounding pharmacy came into extensive scrutiny by federal and state regulatory agencies. Areas Covered in the Session: Introduction to the field of compounding pharmacy Overview of state regulatory agencies governing compounding pharmacy Potential types of exposures to hazardous drugs Who Will Benefit: Compounding Pharmacists Hospital Pharmacists Nurse…
Virtual Seminar on Analytical Method Validation Process

Virtual Seminar on Analytical Method Validation Process

Location: , United States
Category: Education
Start Date: 11-03-2017
Overview: Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods. Why should you Attend: Method validation is the process of demonstrating that analytical procedures are suitable for their intended use and that they support the identity, strength, quality, purity and potency of the drug substances and drug or other products. Areas Covered in the Session: Method Development, Optimization and Validation Approaches Method Validation -High Level System Suitability Validation Components Accuracy Who Will Benefit: Anyone in a laboratory setting that needs to…
Calculating, and Using Statistical Power 2017

Calculating, and Using Statistical Power 2017

Location: , United States
Category: Education
Start Date: 11-06-2017
Overview: This webinar explains the basics, by using a t-test as an example. One of the very many possible formulas is then demonstrated, as well as 2 different software programs and their "Power Curves". Why should you Attend: Whenever a test of statistical significance is conducted with the hope that the result will be non-significant, the results may be unacceptable to a regulatory agency unless the test had an acceptable level of "power". Areas Covered in the Session: Vocabulary and Concepts t-Tests and p-values Statistical Power Who Will Benefit: QA/QC Supervisor Process Engineer Manufacturing Engineer QC/QC Technician Speaker Profile: John…
7 Megatrends that Will Transform the Global Marketplace

7 Megatrends that Will Transform the Global Marketplace

Location: , United States
Category: Education
Start Date: 11-07-2017
Overview: The trends will impact virtually every industry that is dependent on supply chains. There is a convergence of supply chain trends that will dramatically change the global marketplace. Why should you Attend: Understanding of the supply chain trends that will dramatically impact business over the 2-5 years Why purchasing decisions must consider transparency and sustainability Why the triple bottom line is becoming increasingly important Learn the advantage of having production closer to consumers Areas Covered in the Session: Why sustainable supply chains will become more mainstream, especially among luxury buyers and millennials Why low cost country sourcing will be…
Medical Device Hazard Analysis Following ISO 14971 - 2017

Medical Device Hazard Analysis Following ISO 14971 - 2017

Location: , United States
Category: Health and Medicine
Start Date: 11-08-2017
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. Why should you Attend: FDA expects that as part of a product development program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Areas Covered in the Session: Explanation of Hazard Analysis terms Hazard Analysis Process Explanation using a Template Examples of Terms will be given Hazard Analysis Examples will be Covered…
Latest Regulations for Tobacco Industry Effective -2017

Latest Regulations for Tobacco Industry Effective -2017

Location: , United States
Category: Health and Medicine
Start Date: 11-14-2017
Overview: The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Why should you Attend: How to Build a Compliance Strategy Minimizing Cost while Maximizing Compliance Knowing the policies and procedures that must be developed and maintained to support the clinical trial system in operation Areas Covered in the Session: FDA Tobacco Control Act Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries Details of the August 8, 2016 FDA Regulation PMTAs and Requirements Compliance Strategy Cost vs. Compliance Who Will…
Agile Meets Software Standards, and We all Win

Agile Meets Software Standards, and We all Win

Location: , United States
Category: Engineering and Technology
Start Date: 11-14-2017
Overview: Understanding TIR 45 can be the roadmap for improving development and benefiting everyone, companies, development teams, caregivers, patients, and regulators. Why should you Attend: Perhaps you're a development manager, hoping to improve both productivity and quality. Or you are a quality assurance manager, facing a demand from management and development to permit a move to Agile. Areas Covered in the Session: TIR 45 comes at a much needed time TIR 45 stitches together the important high-level concepts Implementation issues are not ignored This TIR is actually just a starting point Who Will Benefit: Software Developers Business Analysts Requirements Analysts…
It is not enough to Simply be a Project Manager

It is not enough to Simply be a Project Manager

Location: , United States
Category: Engineering and Technology
Start Date: 11-16-2017
Overview: We manage tasks and activities, and those activities must be performed by people, who must be led. It is not enough to simply be a Project Manager. Why should you Attend: On average it takes ten successful projects to make up for one really bad project. If your projects are finishing late, if your teams turn over faster than a freshman class in college, if your projects are losing money, then you need to take this course. Areas Covered in the Session: How to meet the needs of the project How to clarify expectations and get buy in How…
How to Recover Time Lost Due to Performance Issues

How to Recover Time Lost Due to Performance Issues

Location: , United States
Category: Education
Start Date: 11-30-2017
Overview: It is just a fact of life that someone on your team, whether you selected them or whether they were assigned to you will be a non-performer. Why should you Attend: Are you spending too much of your own time trying to recover for the poor performance of team members? Are you missing deadlines because others can't get their work to you on time? Areas Covered in the Session: How to identify potential performance issues How to evaluate team member performance How to create sound execution strategies Who Will Benefit: Project Managers Assistant Project Managers Project Directors Program Managers…

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