World Conference Calendar

33622 Conferences

Conferences of Compliance4allrss


Root Cause Analysis for CAPA & Best Practices - 2017

Root Cause Analysis for CAPA & Best Practices - 2017

Location: , United States
Category: Education
Start Date: 12-12-2017
Overview: Refund Policy By attending this webinar you will learn about the RCA toolbox and how to get permanent resolution to your significant quality problems. Why should you Attend: You will waste precious time and money and still end up with unsatisfactory results. This webinar will give you insights and lessons learned from a certified Master Black Belt and industry expert with over 30 years' experience. Areas Covered in the Session: Build the right team Develop a problem statement Failure Investigation Data Collection Who Will Benefit: Quality Engineers Manufacturing Engineers Process Engineers Compliance Specialists Auditors Speaker Profile: Susanne Manz MBA,…
Dietary Supplement Health and Education Act of 1994

Dietary Supplement Health and Education Act of 1994

Location: , United States
Category: Education
Start Date: 12-12-2017
Overview: FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Why should you Attend: To gain a fundamental understanding of FDA's regulation of Dietary Supplements. Areas Covered in the Session: Definition of dietary supplement DSHEA Good Manufacturing Practices Structure/Function Claims Health Claims Who Will Benefit: Compliance Manager Validation Manager Regulatory Manager QC Managers QA Managers Speaker Profile: Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and…
How using such Sampling Plans Leads to Production

How using such Sampling Plans Leads to Production

Location: , United States
Category: Education
Start Date: 12-12-2017
Overview: The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Why should you Attend: Almost all manufacturing companies spend time and money to inspect purchased parts upon receipt, in order to evaluate part quality before the parts Supplier is paid. "AQL" sampling plans are used almost universally for such inspections. However, AQL plans actually provide very little information about part quality. Areas Covered in the Session: Transformations to Normality K-tables Normal Probability Plot Reliability…
How to Validate and use Excel Requirements

How to Validate and use Excel Requirements

Location: , United States
Category: Education
Start Date: 12-14-2017
Overview: In this session you will learn procedures and practices on how to validate and use ExcelŽ requirements , and how to design spreadsheets for compliance , also how to ensure and validate spreadsheet integrity. Areas Covered in the Session: How to design spreadsheets for compliance How to ensure and validate spreadsheet integrity When, what and how much to test? Validation of standard/native Excel functions? Who Will Benefit: QA Managers and Personnel QC Managers and Personnel Analysts and Lab Managers Validation Groups Validation Professionals Speaker Profile: Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource…
Equipment and Facility Qualification 2017

Equipment and Facility Qualification 2017

Location: , United States
Category: Education
Start Date: 12-15-2017
Overview: This webinar removes that confusion between equipment Qualification, process validation and Facility commissioning. Why should you Attend: The Webinar is designed for Quality and Manufacturing in the Pharmaceutical and Biopharmaceutical industries. Areas Covered in the Session: Quality Risk Management Defined Compliance Requirements for Quality Risk Management The Quality Risk Management Model Quality Risk Management Life Cycle Who Will Benefit: Quality Engineers Manufacturing Engineers Line Managers Speaker Profile: Mr. Muchemu , MSc, MBA is the Co-founder and CEO of CGMP University Inc. Training and consulting organization in San Jose, California. Mister Muchemu is an established author of several GMP books.…
Optimizing Process Behavior Using Design of Experiments

Optimizing Process Behavior Using Design of Experiments

Location: , United States
Category: Education
Start Date: 01-05-2018
Overview: This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many common types of experiments and their applications are presented. Why should you Attend: Learn a methodology to perform experiments in an optimal fashion Review the common types of experimental designs and important techniques Develop predictive models to describe the effects that variables have on one or more responses Utilize predictive models to develop optimal solutions Areas Covered in the Session: Motivation for Structured Experimentation(DOE) DOE Approach / Methodology Types of Experimental…
Act for Transportation and Logistics Professionals

Act for Transportation and Logistics Professionals

Location: , United States
Category: Education
Start Date: 01-08-2018
Overview: The FSMA is paradigm shift that moves the focus from food inspections to preventative measures and process compliance. Why should you Attend: Specific provisions of the FSMA that impacts transportation and 3rd party logistics providers Sanitary transportation best practices To develop a food safety plan that identifies potential risks, preventative controls and ongoing monitoring New rules that govern food importers and exporters Areas Covered in the Session: How the trend toward transparency and widespread supply chain knowledge (among consumers) will impact sourcing decisions Why sustainable supply chains will become more mainstream, especially among luxury buyers and millennials Why low…
Ensuring Data Integrity and Safety in Clinical Research

Ensuring Data Integrity and Safety in Clinical Research

Location: , United States
Category: Education
Start Date: 01-09-2018
Overview: Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11. Why should you Attend: The increasing use of computers and increasing complexity, all persons who have any data input requirements to know the set-up and function of the systems they are using. Forewarned is forearmed. Areas Covered in the Session: The CFR definitions of Electronic Record, Electronic Signature, Closed System, Open System, Data Trails, and assure that your data is secure and valid? What needs to happen to make data trails secure and…
The Value of a Human Factors Program

The Value of a Human Factors Program

Location: , United States
Category: Education
Start Date: 01-12-2018
Overview: This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program. Why should you Attend: This year FDA published their priority list for the completion of their Guidance documentation. This annual activity gives us inspection and enforcement insight into the priorities within the agency. Interoperability and Cybersecurity were in the top 3. The implementation of a robust HF program will include both of these disciplines. Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness…
Clinical Data Systems Regulated by FDA

Clinical Data Systems Regulated by FDA

Location: , United States
Category: Health and Medicine
Start Date: 01-12-2018
Overview: Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction. Why should you Attend: You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file. This webinar will also benefit those involved in the conduct of clinical trials, audit and inspection of clinical trial study data and records, and submission of filings to regulatory agencies that involve clinical trial…
Which data and systems are subject to Part 11

Which data and systems are subject to Part 11

Location: , United States
Category: Education
Start Date: 01-16-2018
Overview: This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. Areas Covered in the Session: Which data and systems are subject to Part 11 What Part 11 means to you, not just what it says in the regulation Avoid 483 and Warning Letters Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation Ensure data integrity, security, and protect intellectual property…
To Facilitate a Closed-Loop Problem Resolution System

To Facilitate a Closed-Loop Problem Resolution System

Location: , United States
Category: Health and Medicine
Start Date: 01-17-2018
Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations. Why should you Attend: Expectations for meaningful CAPA, supported by results-driven Failure Investigation and Root Cause Analysis, that addresses and resolves underlying product problems, are growing among regulatory agencies world-wide. Areas Covered in the Session: Regulatory "Hot Buttons" The 4 Basic Steps to Problem Solving A Suggested Investigation Template ID / Document the Problem - CAPA, et al Who Will Benefit: Senior management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Speaker Profile: John E. Lincoln…
Excel - Benefits and Hazards in Office 365

Excel - Benefits and Hazards in Office 365

Location: , United States
Category: Computer Science and Internet
Start Date: 01-19-2018
Overview: In this valuable presentation, Excel expert David Ringstrom, CPA, explains how the Office 365 version of Excel 2016 differs from previous versions and perpetual licensed versions of Excel 2016. Historically, each major version of Excel was identical for all users, but that's no longer the case. Why should you Attend: Apply pivot table-specific options in the Office 365 version of Excel 2016 to minimize repetitive work Learn keyboard shortcuts and tips that will help you work more efficiently in Excel Areas Covered in the Session: Discovering the Recommended PivotTables feature Exploring pivot table options that can only be set…
Products Used in Early Phase IND Studies

Products Used in Early Phase IND Studies

Location: , United States
Category: Engineering and Technology
Start Date: 01-19-2018
Overview: 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 material What to do at really early stages What about special IND studies? What about preclinical studies? Who Will Benefit: Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions QA/QC personnel who need to plan work on early stage material R & D personnel who will contribute data to CMC sections Project managers for product development studies Quality systems auditors Consultants Speaker Profile: Steven…
How software requirements are used in validation

How software requirements are used in validation

Location: , United States
Category: Computer Science and Internet
Start Date: 01-30-2018
Overview: This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing. 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,analyses and tests that FDA feels are necessary to prevent user injuries. Areas Covered in the Session: Software Validation more than Testing Requirements Traceability Risk Analysis Unit,Integration and System Testing Algorithm Validation Challenges to the Software Configuration Management Who Will Benefit: Engineer Engineer Management Software Engineer Programmer Quality Assurance Regulatory Speaker…
Aware of the Similarities and Differences in the files

Aware of the Similarities and Differences in the files

Location: , United States
Category: Education
Start Date: 01-31-2018
Overview: It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Why should you Attend: companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier. Areas Covered in the Session: DHF "Typical" Contents and Deliverables The DMR and DHR / Lot / Batch Record TF / DD Required Contents Parallel Approaches to Documentation…

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