World Conference Calendar

35105 Conferences

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Underutilized and Underappreciated in Management Control

Underutilized and Underappreciated in Management Control

Location: , United States
Category: Education
Start Date: 02-21-2018
Overview: In the highly regulated medical device industry, management responsibility and management review are critical concepts in ensuring a suitable Quality Management System (QMS). Why should you Attend: Management with executive responsibility is responsible for establishing a quality policy and objectives and for demonstrating a commitment to quality. And management at all levels should be aware of and engaged in quality efforts and customer focus. Areas Covered in the Session: Park Doctrine Lessons Learned Effective Management Review How to prioritize, resource, and implement improvements Tools for monitoring and communicating risk and improvement over time How to identify residual risk Who…
Learn Some of the Acceptance Activities in FDA QSR

Learn Some of the Acceptance Activities in FDA QSR

Location: , United States
Category: Education
Start Date: 02-21-2018
Overview: This section plays a major role in both purchasing and in production. It is a major contributor to determine whether your supplier and manufacturing process are working effectively. Why should you Attend: As you ensure that your Quality Management System meets FDA's regulations, you need robust acceptance activities. A gap could result in a Warning Letter, but even worse, it could also create a recall. This presentation provides the implementation information as well as the audit strategy to help verify your processes. Who Will Benefit: Operations Managers Production Supervisors Purchasing Managers Quality Engineers Manufacturing Engineers Speaker Profile: Dan is…
NDAs and INDs for Orally-Administered Drug Products

NDAs and INDs for Orally-Administered Drug Products

Location: , United States
Category: Education
Start Date: 02-28-2018
Overview: This webinar will be helpful to applicants conducting BA/BE studies during the IND period, also FDA guidance recommendations on how to meet the BA and BE requirements in 21 CFR 320 as they apply to oral dosage forms. Why should you Attend: Understanding when Bioavailability and Bioequivalence studies should be done can help attendees avoid having to re-do clinical trials, help to determine dosage regimen that achieves target drug exposure. Areas Covered in the Session: Review definitions necessary for understanding bioavailability and bioequivalence Review of FDA guidance recommendations on how to meet the BA and BE requirements in 21…
How Ensuring Data Integrity in Method Validations

How Ensuring Data Integrity in Method Validations

Location: , United States
Category: Education
Start Date: 02-28-2018
Overview: The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements to ensure Data Integrity. Why should you Attend: The guidance changes how FDA regulated methods will be developed, validated and used. Additionally, how to ensure Data Integrity will be discussed. The webinar will focus on detailing all key components of the guidance and analyze its validation parameters, tests, and acceptance criteria with respect to Data Integrity. Areas Covered in the Session: Scope and Content of the Guidance Performing Pre-Validation Studies Analytical Method Transfer Studies Data Integrity and Documentation Requirements Who Will Benefit:…
FDA regulations and the ICH GCP recommendations

FDA regulations and the ICH GCP recommendations

Location: , United States
Category: Education
Start Date: 03-06-2018
Overview: It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. To not follow the protocol and document study conduct carelessly is folly. Why should you Attend: All CRO's, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning the…
Recent Updates of FDA 21 CFR 11 Add-On Inspections

Recent Updates of FDA 21 CFR 11 Add-On Inspections

Location: , United States
Category: Health and Medicine
Start Date: 03-07-2018
Overview: This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome. Why should you Attend: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. Areas Covered In the Session: What is FDA's…
Essentials of Dealing with Non-Conforming Material

Essentials of Dealing with Non-Conforming Material

Location: , United States
Category: Education
Start Date: 03-08-2018
Overview: You'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Why should you Attend: Dealing with non-conforming material is a necessary process for medical device manufacturers. Yet, non-conforming material is a top reason for 483 and Warning letter citations. Areas Covered in the Session: Overview of the Regulations Definitions and Expectations Segregation and Control Disposition of NC material Concessions Who Will Benefit: Quality Systems Specialists Document Control Specialists Quality and Compliance Specialists Internal Auditors and Managers Quality Engineers Speaker Profile: Susanne Manz MBA, MBB, RAC,…
How to Develop Predictive Warranty Using Paynter Charts

How to Develop Predictive Warranty Using Paynter Charts

Location: , United States
Category: Education
Start Date: 03-08-2018
Overview: Attendees will see how to actively utilize representative return data, observe the construction of a sample Paynter and then observe the results of the predictive analysis. Why should you Attend: Quality practitioners must understand how their VOC field return information can be leveraged to aid them in proactively mitigating risk and working across the supply chain when something goes wrong. Areas Covered in the Session: To help people understand how Paynter Charts can be effectively utilized for predictive warranty management Increased understanding of how to share results with management to mitigate business exposure Who Will Benefit: Quality, Lean and…
FDA Process Analytical Method Validation

FDA Process Analytical Method Validation

Location: , United States
Category: Education
Start Date: 03-09-2018
Overview: An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Why should you Attend: Observations that test methods are inadequate or the firm does not have appropriate data that demonstrates the method performs as intended rank high on the list of observations in the laboratory. Areas Covered in the Session: FDA System Based Inspection Guidance Laboratory Control System Most common observations in the laboratory Warning letter observations and analysis Who Will Benefit: Quality Control Manager Supervisors Analysis and Microbiologists Speaker Profile: John (Jerry) Lanese is an…
How to Manage and Improve Human Reliability

How to Manage and Improve Human Reliability

Location: , United States
Category: Education
Start Date: 03-13-2018
Overview: This course offers practical approaches and tools to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues. Areas Covered in the Session: Background on Human Error Phenomena and measurement Importance of Human Error Prevention/reduction Quantitative and qualitative information gathering Why do we need tools for human error reduction programs? Who Will Benefit: Training Managers and Coordinators Operations Manufacturing Plant Engineering Speaker Profile: Ginette Collazo , PH.D is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development…
Eliminating Microbial Contamination in a Spiral Freezer

Eliminating Microbial Contamination in a Spiral Freezer

Location: , United States
Category: Education
Start Date: 03-13-2018
Overview: It is able to enhance sanitation programs as it is able to penetrate the niches and crevices that were previously too hard to reach. By eliminating the ability for pathogens to "hide," chlorine dioxide gas is able to leave food processing environments cleaner and safer than ever before. Why should you Attend: Food production facilities are facing greater scrutiny from both the public and the government to provide safe foods. There are about 48 million cases of foodborne illness annually. That's 1 in 6 Americans each year. The FDA will be aggressive in its environmental monitoring and sampling under…
Dietary Supplements CGMPS - 21 CFR 111 Compliance 2018

Dietary Supplements CGMPS - 21 CFR 111 Compliance 2018

Location: , United States
Category: Health and Medicine
Start Date: 03-14-2018
Overview: This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Why should you Attend: Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress defined the term "dietary supplement", and requires that every supplement be labeled a dietary supplement. Areas Covered in the Session: Required steps for CGMP compliance Problem areas, common pitfalls Implementation:Systems,templates and tools Who Will Benefit: Senior Management in Dietary Supplements Industry QA/RA R&D Engineering Marketing Consultants Speaker Profile: John E. Lincoln is a medical device…
Write an Effective Standard Operating Procedure

Write an Effective Standard Operating Procedure

Location: , United States
Category: Education
Start Date: 03-14-2018
Overview: This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. Why should you Attend: Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet there is no guidance on how to write, organize and maintain SOPs. Areas Covered in the Session: SOPs and their relation to the regulations SOPs as part of the company's regulatory infrastructure SOP…
GMP for Phase I Investigational Drug Products 2018

GMP for Phase I Investigational Drug Products 2018

Location: , United States
Category: Education
Start Date: 03-22-2018
Overview: Phase I clinical trials are the first time that investigational new drugs are introduced into human subjects and, although it is very, very important for all drugs to be manufactured using GMPs, it is probably more important than at any other time during the lifecycle of the product, that a product be safe whenever humans are being exposed to it for the first time. Why should you Attend: FDAs guidance document "Good Manufacturing Practice for Phase I Investigational Drug Products" applies to correct GMP requirements to drug products made for the purpose of using an investigational drug product on…
European Data Protection Regulation - 2018 Implementation

European Data Protection Regulation - 2018 Implementation

Location: , United States
Category: Health and Medicine
Start Date: 03-29-2018
Overview: An overview of the history of Data Protection within the EU and introduce you to the enhancements and new obligations imposed by the EU GDPR. Why should you Attend: Attendees will learn the common EU rules that have been established to ensure that personal data has a high standard of protection across the EU. Attendees will also learn about their rights to complain and obtain redress if their data is misused in any of the EU member states. Areas Covered in the Session: How EU Data Protection Regulation affect social networks How EU Data Protection Regulation benefit existing European…
How to Identify the Causes Behind the Autism Spectrum Disorder

How to Identify the Causes Behind the Autism Spectrum Disorder

Location: , United States
Category: Education
Start Date: 03-30-2018
Overview: This is an interactive overview of how DMAIC can be utilized in a home environment to improve the quality of life for a child diagnosed as being on the Autism Spectrum. Why should you Attend: The same tools and skills can be applied to any other form of personal or professional issue. This session rated first at the ASQ WCQI conference when it was presented there. It leaves people motivated and refreshed with a plan of how to manage systems with a toolkit that they can easily apply. Areas Covered in the Session: To help people understand how lean…

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