Activity
My Events (67)
http://pickevent.com/Compliance4all
Biography
Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits.

No fib -Compliance4All is the complete destination for all that you want with regulatory trainings. You will have the same features that leading providers of regulatory and compliance trainings provide -the same world class, industry-renowned professionals, flexibility of trainings, credits for advancing your career, and a range of instruction mediums -but at a significantly lower price. Say goodbye to elitist, expensive trainings.

In addition, as an online training solutions provider that brings the world's best known names for regulatory and compliance trainings through webinars that fill your knowledge gap; Compliance4All comes with other major benefits:

The webinars are simple and focused on your particular area of interest;
We have a panel of Experts that has vast and deep knowledge and expertise of the subject matter;
Our webinars foster interaction with Experts. This is a great opportunity to have all your doubts cleared;
Participants can participate from any part of the world.

Compliance4All has experts who share a wealth of knowledge covering best practices in industry. These trainings help participants refresh their knowledge about regulatory compliance. Our panel of Experts imparts learning on a number of areas relating to compliance, such as:

Medical Devices
Pharmaceutical
Food
PCI industries, and
SOX

Our webinars cover the following Governing Areas:

FDA
GxP (Manufacturing/Clinical/Lab)
CMDR
EU
ISO
SOX and
PCI

These are the functional areas Experts from Compliance4All offer their expertise on:

Regulatory
Clinical Trials, and
Quality
Activity
Compliance4all created an event

WEBINAR

SEP

30

10:00 AM

Product Risk Management - ISO 14971:2007

Fremont, CA, USA

Overview:  This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool. The U.S. FDA has stated that the use of a medical device entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time. ISO 14971 provides an accepted vehicle by which to perform and document such an...

Product Risk Management
ISO 14971:2007
Compliance4all created an event

WEBINAR

SEP

25

10:00 AM

FDA Inspections – Do's and Don'ts

Fremont, CA, USA

Overview:  Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency. Why should you Attend: If you are looking for answers to these questions, you would certainly benefit by...

FDA Inspections
Compliance4all created an event

WEBINAR

SEP

24

10:00 AM

The Role of FDA in Health Care Software Regulations and Development

Fremont, CA, USA

Overview:  This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device Why should you Attend: Inadequate validation of software continues to be a leading component of device warning letters. Problems mainly include 1) Software that is a component of the manufacturing...

FDA in Health Care Software Regulations
Health Care Software regulation
Compliance4all created an event

WEBINAR

SEP

17

10:00 AM

Avoiding Pitfalls With Air Barriers

Fremont, CA, USA

Overview:  With the proliferation of the use of air barriers in building enclosure systems the potential for problems exists in the industry. This workshop will review the proper planning, product selection, specifications, details and field quality assurance needed for a successful air barrier installation. The program starts with a list of steps to be taken during each phase of design and construction. Proper exterior wall design based on type of construction and proper material selection based on type of construction will then be reviewed. Details for specific wall construction type and...

quality assurance guidelines
Avoiding Pitfalls With Air Barriers
Compliance4all created an event

WEBINAR

SEP

15

10:00 AM

FDA's enforcement of 21 CFR part 11 compliance

Fremont, CA, USA

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. In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made...

21 CFR part 11 compliance
FDA's enforcement of 21 CFR part 11
Quality Assurance and Regulatory Affairs
Compliance4all created an event

WEBINAR

SEP

15

10:00 AM

FDA's enforcement of 21 CFR part 11 compliance

Fremont, CA, USA

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. In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made...

21 CFR part 11 compliance
FDA's enforcement of 21 CFR part 11
Quality Assurance and Regulatory Affairs
Compliance4all created an event

WEBINAR

SEP

15

10:00 AM

Introduction to Risk Assessment

Fremont, CA, USA

Overview:  Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern. Why should you Attend: The reason for attending would be to gain a perspective and understanding of the proper...

Risk Assessment
cGMP Compliance in the Medical Device
Compliance4all created an event

WEBINAR

SEP

15

10:00 AM

1099 and W-9 Update - Complying with IRS Information Reporting

Fremont, CA, USA

Overview:  What are the rules regarding paying and IRS reporting on Independent Contractors? How do I avoid the IRS CP-2100 (B-Notices)? What if my vendor claims exemption; must I obtain a W-9 anyway? What are the best practices? How can I minimize risk of improper exemption claims by my vendors? Get the answers to these and related questions to reduce your risk of huge penalties from the IRS. Why should you Attend: Learn the rules requiring W-9 documentation and 1099 reporting. Learn how to establish the independent contractor relationship with the right documentation. Understand the...

1099 and W-9 Update
W-9 documentation and 1099 reporting
Form W-9
Compliance4all created an event

WEBINAR

SEP

09

10:00 AM

Device Changes, FDA Changes, and the 510(k)

Fremont, CA, USA

Overview:  The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize...

fda compliance
fda
Compliance4all created an event

WEBINAR

SEP

09

10:00 AM

Device Changes, FDA Changes, and the 510(k)

Fremont, CA, USA

Overview:  The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize...

fda compliance
fda
Compliance4all created an event

WEBINAR

SEP

01

10:00 AM

Bullet Proof 510(k) – Latest FDA Changes to the Process

Fremont, CA, USA

This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Overview:  There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review...

Bullet Proof 510(k)
Premarket Notification 510(k)
21 CFR 807
Compliance4all created an event

WEBINAR

AUG

27

10:00 AM

Corrective Actions - Current Expectation of ISO 13485 and FDA Auditors

Fremont, CA, USA

Overview:  This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. There will be a review of the corrective and preventive action requirements. We will cover how corrective actions should be used throughout your Quality Management System. Definitions of Correction and corrective actions, their differences and importance will be covered. Examples of each will be provided. Information will be provided to make sure your Corrective Action system including your procedures meets...

ISO 13485 and FDA
FDA Corrective Actions expectations.
ISO 13485 compliance
ISO 9001 and ISO 13485
Compliance4all created an event

WEBINAR

AUG

26

10:00 AM

Meeting Annual U.S. FDA cGMP Training Requirements

Fremont, CA, USA

Overview:  There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and recent public concern over insufficient oversight of new product introductions (and grandfathered product) by means of the 510(k) system. Business continues to "shoot itself in the foot", including...

FDA cGMP Training
FDA CGMP compliance audits
cGMP compliance training
FDA / ISO compliance
Compliance4all created an event

WEBINAR

AUG

26

10:00 AM

Personal Hygiene

Fremont, CA, USA

In this program participant will become aware of how effective personal hygiene protects against the transmission of diseases and the development of foodborne illness.  Overview:  This topic will address the importance of personal hygiene and how this condition can be attained and maintained. An understanding of the meaning of food sanitation will be established and why the maintenance of effective personal hygiene is important to all businesses that require effective sanitation. The role of people in the maintenance of effective personal hygiene will be addressed. The role of carriers...

Personal Hygiene
food processing
foodservice
food sanitation
Compliance4all created an event

WEBINAR

AUG

26

10:00 AM

Medical Device Recalls

Fremont, CA, USA

Overview:  Companies need to remain vigilant in understanding and applying current FDA law and regulation pertaining to the marketing of their devices in the US. Failure to do this raises their regulatory risk and hampers their ability to stay competitive in the rapidly advancing technological world of medical device manufacturing and marketing. Effectively managing recalls reduces regulatory risk and allows problem recovery to begin more quickly. The stakes are high and growing even higher as device regulatory authorities around the globe are harmonizing their regulatory standards and...

Medical Device Recalls
FDA law and regulation
FDA Role and Expectations
Compliance4all created an event

WEBINAR

AUG

18

10:00 AM

How to Design and Implement Outstanding KPI Performance Dashboards

Fremont, CA, USA

In just 90 minutes, Miles Hutchinson, experienced CGMA and business adviser, will explain how to get the most from your KPI dashboards and help improve your bottom line!  Overview:  Grab a cup of coffee and join us to learn how to improve your KPI focus, and juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Ensure your Performance Dashboards are crisp, attention grabbing and clearly identify significant performance trends. Know whether your business is meeting or exceeding its goals with your early warning...

KPI Performance Dashboards
Performance Dashboards
Compliance4all created an event

WEBINAR

AUG

13

10:00 AM

FDA Regulation of Dietary Supplements

Fremont, CA, USA

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. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA): Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all...

FDA Regulation of Dietary Supplements
Dietary Supplement Health and Education Act
FDA regulations
dietary supplement product
Compliance4all created an event

WEBINAR

AUG

11

10:00 AM

Business Continuity Management: Architect and Implement Solution

Fremont, CA, USA

Overview:  Learn to properly prepare for an impact to the business for any organization. We will cover how to identify, analyze and document the events and environmental surroundings that can adversely affect the organization. You will learn how to both prepare and review the continuity planning program. Areas such as IT Outsourcing and other risks will be covered. It is critical to assess the IT and Information Security risks and the effectiveness of the institution’s risk management processes as they relate to the security measures  Why should you attend: Banks are the most...

Business Continuity Management
continuity planning program
risk management
Regulatory requirements
Compliance4all created an event

WEBINAR

AUG

10

10:00 AM

Medical Device Registration & Listing, and Inspection Follow-up Activities

Fremont, CA, USA

Overview:  Companies need to remain vigilant in understanding and applying current FDA law and regulation pertaining to the marketing of their devices in the US. Failure to do this raises their regulatory risk and hampers their ability to stay competitive in the rapidly advancing technological world of medical device manufacturing and marketing. The stakes are made even higher as device regulatory authorities around the globe are harmonizing their regulatory standards and requirements while increasing their collaborative efforts to ensure product safety. This webinar will explore key...

Medical Device Registration
FDA law and regulation
Good Manufacturing Practice
Compliance training
Compliance4all created an event

WEBINAR

AUG

07

10:00 AM

Efficient and Effective FDA and ISO Management Reviews

Fremont, CA, USA

This session will discuss how to make your Management review fit your company and the best ways to get involvement from your senior management.  Overview:  In this presentation will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. Management review should be a key part of keeping your quality management system efficient and effective. It will cover how to get the attention of your senior management as well as practical advice on efficient methods for conducting and documenting management reviews. Included will be best...

FDA and ISO Management
fda
compliance
training
Compliance4all created an event

WEBINAR

AUG

04

10:00 AM

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

Fremont, CA, USA

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. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be...

Standard Operating Procedure
Clinical compliance
compliance training
Compliance4all created an event

WEBINAR

AUG

03

10:00 AM

How to Survive an FDA Inspection

Fremont, CA, USA

Overview:  Bioresearch monitoring program or BIMO is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research The BIMO program monitors: Sponsors/Contract Research Organizations (CROs)/Monitors Institutional Review Boards (IRBs) Clinical Investigators (CIs) Nonclinical Laboratories Why should you Attend: BIMO Program Objectives are to Protect the rights, safety, and welfare of human research subjects and Assure the quality, reliability, and integrity of data collected. BIMO...

FDA Inspection
fda compliance training
compliance training
Compliance4all created an event

WEBINAR

JUL

28

10:00 AM

Current Status of Biosimilars in US, Europe and Canada

Fremont, CA, USA

Overview:  Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe. Finally, we will address Europe and where the landscape is in terms of approval and market accessibility. We will address an interchangeability study ongoing in Denmark and new legislation in France using public policy to drive use of biosimilars. We will address upcoming patent losses, and...

Current Status of Biosimilars
fda compliance training
webinar
training for professional
Compliance4all created an event

WEBINAR

JUL

24

10:00 AM

Conducting Safety Reviews for Systems, Products, Processes, facilities, and Procedures

Fremont, CA, USA

Overview:  This webinar discusses the concept of conducting an inclusive safety reviews in order to evaluate associated risks and mitigations. Safety axioms appropriate to the safety review concept are discussed. Areas Covered in the Session: What is a hazard? What is a risk? What is hazard analysis? What is risk? What is risk assessment? What are illogical concepts and mindsets? How will these concepts and mindsets adversely affect safety? What is a safety review? How to conduct a safety review? What are the types of safety review? Decision makers that may effect...

risk management
hazard system
hazard analysis
System Safety
Compliance4all created an event

WEBINAR

JUL

24

10:00 AM

Managerial Primer for Assuring Information Security

Fremont, CA, USA

 Information and associated technologies continue to advance toward diverse distributed configuration environments for entering, processing, storing, and retrieving data. The magnitude of changes occurring can be clearly seen in the explosion of linked IT infrastructures connected to cloud computing service providers and mobile computing devices. Consequently, the impact of such decentralization has increased the need for effective safeguarding of information assets.  Foundationally paraphrasing from Title 44, Chapter 35, Subchapter III, Section 3542(b)(1) of the United States Code; the...

Information Security
risk management
information security strategy
Compliance4all created an event

WEBINAR

JUL

22

10:00 AM

FDA Export Certificates for Medical Devices

Fremont, CA, USA

Overview:  Companies need to stay internationally competitive and this webinar on export certificates provides a key link for entry to markets around the globe. This webinar will explore the export approval and certification process in the U.S. It will include guidance on preparing applications and obtaining FDA's certification that specific products identified for export meet U.S. regulatory requirements. All of this will be valuable in obtaining broader access to global markets. Why should you Attend: In today's global environment, sustaining competitive advantage within the medical...

FDA
Medical Devices
regulatory requirements
global manufacturers of medical devices
training
Compliance4all created an event

WEBINAR

JUL

10

10:00 AM

Managing Your Medical Device Reporting (MDR) Program for Compliance Success

Fremont, CA, USA

Overview:  Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. If you are a consumer or health professional you should use the MEDWATCH program for reporting significant adverse events or product problems with medical products. Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous...

Medical Device Reporting
MDR regulations
MDR procedures
Safe Medical Devices Act
Compliance4all created an event

WEBINAR

JUL

09

10:00 AM

Preventing Recalls & Product Liability in New Product Development

Fremont, CA, USA

One of the first requirements in this proactive effort is for today's manufacturing executive teams to learn how to perform Design Reviews and Product Safety - Hazard Analysis Reviews in order to help identify and prevent the possibilities of launching a defective designed product. Almost every manufacturing company already feels they're properly conducting design reviews, only to find that they're not even coming close. And they don't understand the difference between Design Reviews and Product Safety Reviews, nor did anyone probability ever receive formal training in Hazards Analysis and...

Product Liability in New Product Development
Design Reviews and Product Safety
webinar
training
Compliance4all created an event

WEBINAR

JUL

07

10:00 AM

Regulation of the Practice of Geology in the United States

Fremont, CA, USA

This program offers an objective, thorough review of the common basics of state regulation of the profession of geology.  Why should you Attend: Identifying and understanding the professional practice of the earth sciences is a daunting task in today's multidisciplinary environment. Earth sciences bring together a number of diverse professionals working in a common setting of the environment. As independence for our nation's energy needs becomes critical to our national security, geologists - and other professionals - provide a unique role in identifying, tapping, and extracting our...

Practice of Geology in the United States
professional practice of the earth sciences
compliance
regulation
webinar
training
Compliance4all created an event

WEBINAR

JUL

07

10:00 AM

FDA Regulation of Combination Products

Fremont, CA, USA

Attend this 60 minutes presentation to gain a fundamental understanding of FDA’s regulation of Combination Products. Overview:  A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Under 21 CFR 3.2 (e), a combination product is defined to include: A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or...

FDA Regulation
Combination Products
biological product
webinar
training
Compliance4all created an event

WEBINAR

JUL

06

10:00 AM

Good Clinical Practice (GCP)

Fremont, CA, USA

Overview:  Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines. GCP...

Good Clinical Practice
clinical trials of medical devices
Good Clinical Practice standards
webinar
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