HOW TO PRICE WHAT YOU SELL is one of the most important and troublesome issues for any small business.

And, business owners and their managers need clear strategies for price setting to ensure they survive and thrive as a profitable business.

In this one-hour online seminar, Veronica, an experienced Small Business Coach with

Pricing Strategies as a niche, will share four strategies, tips and insights on how small business owners can get their pricing right.

This one-hour session will cover:

- 4 successful PRICING STRATEGIES small businesses (incl. sole traders) can use

- Key PITFALLS TO AVOID in setting your prices

- How to create PRICING MENUS for your business

- Key points to consider about TIME AND MONEY spent on your business

In the final 10 minutes of the online seminar, I will answer your questions about pricing.

Do ensure you sent your questions when your register.

NB: Everyone attending will RECEIVE A FREE PRICING TEMPLATE. You can adapt it for your business.

Cost: 59 EUR

To get 19 EUR off the price, use this promo code before 11pm on Saturday 16 March: YSBCPS113 (pay 40 EUR only at checkout).

ABOUT PRESENTER AND TRAINER

Veronica is the Founder of Your Small Business Coach, a Business Coaching and Training business based in London which works with business owners and entrepreneurs in the UK either face to face or using technology such as Skype, telephone or online conference rooms for both UK and overseas clients. ‘Your Small Business Coach’ supports new and experienced owners, directors and managers of small businesses to set clear and realistic business targets which can be achieved in less time and with fewer pitfalls.

A qualified and experienced Small Business Coach, Veronica has developed pricing strategies for SME as a niche and provides training and advice to small businesses owners and has worked with scores of start-up and growing businesses, directly and through business support agencies.

HERE`S WHAT OTHERS SAID about Veronica's seminars on Pricing Strategies and Creating Pricing Menus:

"Veronica, gave a talk on pricing strategies for my networking event. It went down really well and I would recommend Veronica for workshops and seminars, as she know her stuff." One of the tips was to reward our employee's when they referred someone to the business. Likewise to reward our customers for any referral too. So simply when you think of it!”

"Excellent talk by Veronica, made a full page of notes".

“Veronica is very good at giving advice about pricing strategies in business. She is very straight-forward and to the point.”

“Veronica's workshop was really helpful and now I am building a menu of prices feeling confident in the knowledge of how to do it. I am very grateful.”

“Having attended Veronica's Pricing model course, I was very satisfied the course content and her practical approach to setting prices. I will highly recommend her work to anyone.”

Date: 20.03.2013
Start: 11:30 (GMT) / End: 12:30 (GMT)

HOW TO PRICE WHAT YOU SELL is one of the most important and troublesome issues for any small business.

And, business owners and their managers need clear strategies for price setting to ensure they survive and thrive as a profitable business.

In this one-hour online seminar, Veronica, an experienced Small Business Coach with Pricing Strategies as a niche, will share four strategies, tips and insights on how small business owners can get their pricing right.

This one-hour session will cover:

- 4 successful PRICING STRATEGIES small businesses (incl. sole traders) can use

- Key PITFALLS TO AVOID in setting your prices

- How to create PRICING MENUS for your business

- Key points to consider about TIME AND MONEY spent on your business

In the final 10 minutes of the online seminar, I will answer your questions about pricing. Do ensure you sent your questions when your register.

NB: Everyone attending will RECEIVE A FREE PRICING TEMPLATE. You can adapt it for your business.

Cost: 59 EUR

To get euros 10 off the price, USE THIS PROMO CODE BEFORE 11PM ON SATURDAY 24 February: YSBCPS113 (pay 49 EUR only at checkout).

ABOUT PRESENTER AND TRAINER

Veronica is the Founder of Your Small Business Coach, a Business Coaching and Training business based in London which works with business owners and entrepreneurs in the UK either face to face or using technology such as Skype, telephone or online conference rooms for both UK and overseas clients. ‘Your Small Business Coach’ supports new and experienced owners, directors and managers of small businesses to set clear and realistic business targets which can be achieved in less time and with fewer pitfalls.

A qualified and experienced Small Business Coach, Veronica has developed pricing strategies for SME as a niche and provides training and advice to small businesses owners and has worked with scores of start-up and growing businesses, directly and through business support agencies.

HERE`S WHAT OTHERS SAID about Veronica's seminars on Pricing Strategies and Creating Pricing Menus:

"Veronica, gave a talk on pricing strategies for my networking event. It went down really well and I would recommend Veronica for workshops and seminars, as she know her stuff." One of the tips was to reward our employee's when they referred someone to the business. Likewise to reward our customers for any referral too. So simply when you think of it!”

"Excellent talk by Veronica, made a full page of notes".

“Veronica is very good at giving advice about pricing strategies in business. She is very straight-forward and to the point.”

“Veronica's workshop was really helpful and now I am building a menu of prices feeling confident in the knowledge of how to do it. I am very grateful.”

“Having attended Veronica's Pricing model course, I was very satisfied the course content and her practical approach to setting prices. I will highly recommend her work to anyone.”

Date: 27.02.2013
Start: 11:30 (GMT) / End: 12:30 (GMT)

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits

Areas Covered in the Session:

How to prepare for an FDA inspection

Development and contents of an SOP for FDA inspection

Personnel training before inspection

How to behave during an inspection

Limitations of scope of inspection

Response to investigation findings

FDA guidance documents used by their inspectors

Webinar Includes:

-Q/A Session with the Expert to ask your question

-PDF print only copy of PowerPoint slides

-60 Minutes Live Presentation

Who will benefit: The designations

This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

Executive/senior management
Regulatory management
QA management
Any personnel who may have direct interaction with FDA officials
Consultants
Quality system auditors

About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Under regulations now being finalized, Business Associates of HIPAA Covered Entities will be covered directly under the HIPAA regulations, and will have to create HIPAA Privacy, Security, and Breach Notification compliance programs. In addition, any subcontractors of Business Associates will fall under the same rules and will need to be HIPAA compliant.

Areas Covered in the Session:

* Learn about the new requirements for HIPAA Business Associates

• Find out what is changing in the regulations for Business Associates
• Learn how the definition of BA has been significantly expanded
• Learn what goes into a proper Business Associate Agreement
• Find out about the new, higher enforcement penalties
• Learn about the new violation categories
• Learn about being prepared for a HIPAA Compliance Audit

Agenda:

I. Old Ways, New Ways - Changes to the Rules
A. Origins of Changes to Business Associate Rules
B. New Definitions of Business Associates
C. Contractors of Business Associates

II. New Requirements and Changed Requirements for HIPAA Business Associates
A. HITECH Act Required Capabilities
B. Required Amendments to BAAs
C. BAA Provisions to Consider
D. Transitioning to the New Rules

III. Enforcement and Audits
A. New HIPAA Violation Categories
B. New HIPAA Penalty Structure
C. Preparing for HIPAA Audits

Why should you Attend:

In the past, business associates of HIPAA covered entities were not directly covered under HIPAA and were required to conduct themselves only according to the contract with the covered entity being served. The American Recovery and Reinvestment Act of 2009 (ARRA) establishes new requirements for business associates (BAs) who handle the protected health information of covered entities under HIPAA. In addition, Federal Breach Notification requirements for health information directly impact the relationship of covered entities, business associates, and their subcontractors.
New HIPAA regulations being finalized in 2012 put HIPAA business associates and their subcontractors directly under the HIPAA rules and make them responsible for the privacy and security of the information they handle, as well as liable for violations under the rules. Now BAs will need to be in compliance with HIPAA Privacy and Security protections, and must also treat all their contractors as BAs as well, meaning that new agreements must be established between parties that have not formerly been required to have formal agreements, and existing agreements must be amended. And the business associate definition now is expanded to include entities such as health information exchanges, regional health information organizations, and e-prescribing gateways.
Under the proposed regulations, specific language must be incorporated in all HIPAA BA agreements, and ARRA requires that business associates can be subject to random compliance audits by the US Department of Health and Human Services. HIPAA breach notification requirements enacted in 2009 also apply to business associates, which means that all existing agreements must be examined to ensure that liability, indemnification, and notification are properly covered in the agreements.

Description of the topic:

• The new HIPAA Business Associate rules change the game for HIPAA compliance responsibility. We will discuss how the responsibilities have changed and how the changes affect both Business Associates and Covered Entities. Not only have the rules changed, but also there are new kinds of businesses now covered as HIPAA BAs such as Health information exchanges, e-prescribing initiatives, patient safety organizations, and now even the subcontractors of Business Associates, greatly expanding the pool of entities directly under Federal health care regulation.

• The new rules require updating all existing Business Associate Agreements (BAAs). We will discuss what goes into a compliant HIPAA Business Associate agreement, including what's required and what's advisable to protect parties in the event of breaches. The new regulatory language for HIPAA business associates will be explained and discussed. How a BA deals with making their contractors BAs under the new rules will be examined, and the chain of Business Associate relationships will be discussed.

• The new responsibilities for business associates will be explored, as well as the new liabilities for business associates under the rules. In essence, Business Associates are now subject to the same Security Rule safeguards, and restrictions on uses and disclosures under the Privacy Rule, as Covered Entities, and are equally as responsible for adopting BAAs and equally subject to penalties for violations.

• What goes into a compliance plan will be discussed and we will discuss how to develop your compliance plan and how to prepare for a HIPAA audit. Showing your compliance is a matter of showing that you have adopted sufficient policies and procedures, and that you have been using them through documented actions.

• The new HIPAA penalty structure will be discussed, including new criminal penalties for individuals involved with wrongful disclosures, new mandatory penalties for willful neglect of compliance (starting at $10,000 and going up), and the new, four-tier penalty structure and definitions.

• The session will provide attendees the following tools, benefits, and solutions:
- The audience will learn how business associates are now handled under the law and the proposed regulations and what has changed from the old rules.
- The suggested and required content for a compliant business associate agreement will be presented.
- Issues of how to assign liability and costs in the event of a breach will be discussed.
- Current BAs will learn what they have to do to get their contractors established as their business associates.
- BAs will discover the new obligations on them to ensure their clients comply with HIPAA in their dealings with the BA.
- BAs will learn how to be prepared for compliance audits and avoid the mandatory penalties for willful neglect of compliance.

Who will benefit: The designations

Compliance director
CEO
CFO
Privacy Officer
Security Officer
Information Systems Manager
HIPAA Officer
Chief Information Officer
Health Information Manager
Healthcare Counsel/lawyer
Office Manager
Contracts Manager

About Speaker

Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a variety of health care providers, businesses, universities, small and large hospitals, urban and rural mental health and social service agencies, health insurance plans, and health care business associates. He serves on the HIMSS Information Systems Security Workgroup, has co-chaired the Workgroup for Electronic Data Interchange Privacy and Security Workgroup, and is a recipient of the 2011 WEDI Award of Merit. He is a frequent speaker regarding HIPAA and information privacy and security compliance issues at seminars and conferences, including speaking engagements at AHIMA national and regional conventions and WEDI national conferences, and before the New York Metropolitan Chapter of the Healthcare Financial Management Association, Health Information Management Associations of Virginia, New York City, New York State, and Vermont, the Connecticut Hospital Association, and the Hospital and Health System Association of Pennsylvania. Sheldon-Dean has nearly 30 years of experience in policy analysis and implementation, business process analysis, information systems and software development. His experience includes leading the development of health care related Web sites; award-winning, best-selling commercial utility software; and mission-critical, fault-tolerant communications satellite control systems. In addition, he has eight years of experience doing hands-on medical work as a Vermont certified volunteer emergency medical technician. Sheldon-Dean received his B.S. degree, summa cum laude, from the University of Vermont and his master’s degree from the Massachusetts Institute of Technology.

This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.
Upon completion of this course, attendees will understand how to prepare and file DMFs with the FDA and the rationale behind doing so. Participants will gain practical knowledge about what reviewers look for in DMFs, the consequences that can be expected as a result of non-compliance, and strategies for avoiding the most common DMF-related errors. The course will also emphasize the "organic" nature of DMFs , present strategies for establishing and maintaining effective change control programs , along with facilitating effective communications with regulatory agencies and your own customers and vendors.

Why Should You Attend

This course provides attendees with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. The DMFscourse will take participants through a step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.

The course offers methodologies and techniques on:

Who really needs a DMF and why?
The various types of DMFs - which is best for your products.
The relationship between DMFs and drug and biologics applications.
The symbiotic relationship between DMFs and current Good Manufacturing Practices (cGMPs).
Common DMF errors - how to avoid them.
How to deal with deficiency letters and their origins.
Effective change control strategies.
Ramifications of inadequate preparation and/or maintenance and recent enforcement actions and inspectional trends.

Seminar Agenda
What are DMFs?
Types of DMFs (Types II, III, IV and V)

The rationale and preparation process for DMFs
Why DMFs are important to you and your company
How DMFs fit into FDA's regulatory processes for review of drug and biologic applications
Why, more than ever, you may need DMFs to maintain current supplier agreements as well as to develop new business relationships
What not to include

DMF Preparation: What you need and why you need it

The essential components of all DMFs, including:
The relationship between DMFs and cGMPs
Tactics for avoiding the most common DMF-related errors
Tactics for dealing with unique or novel situations/unfavorable reviews
.
FDA Review: How FDA reviews DMFs and why.
What you should expect throughout the DMF preparation and filing process
How to communicate and work with FDA to ensure success

Components Associated with a DMF:
DMF vs. Application
Acknowledgement Letter
Letter of Authorization
Changes to a DMF
Annual updates
Obligations of a DMF holder
Transmissions - transmittal letter
Deficiency letter
Auditing Vendor
Inside tips
Changes to DMF system in last 10 years
Binder specifications and cover sample

Japan DMFs
European DMFs
Canadian DMFs
Change control and maintenance: Why accurately maintaining your DMFs is important
DMFs as "living" documents. DMF updates and amendments
Types of DMF-related changes that impact drug/biologic applications: production facilities, composite materials, manufacturing processes
What you must report and to whom - the importance of establishing communication pathways with regulatory agencies, customers and vendors

Who Will Benefit:

This course is developed for those involved in the manufacture of pharmaceutical and biologic products, components, and packaging materials. The course will be especially useful for personnel responsible for:

Manufacturing
Regulatory Affairs
Research and Development
Quality Assurance & Control
Validation
Development and Preparation of Submission Materials

About Speaker

Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.

The terms Fair Lending and UDAAP tend to strike fear and panic in the hearts of many financial industry professionals due to their over-arching and vastly subjective interpretations. Unlike more "traditional" regulations these two fundamental pillars of ethical banking interweave the grey areas that connect the regulatory environment with risk management. The end result is a veritable mine field for even the most seasoned financial industry professionals when it comes to balancing successful business operations and consumer protection. The goal of this webinar is to help demystify these terms and provide you with a better way forward for managing the risks associated with these aspects of consumer protection.

Why should you attend:

Current and future compliance professionals, lenders, loan originators, board of directors, senior management. Anyone responsible for the development, marketing, and sales of bank products or services.

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Areas Covered in the Session:

The goal of consumer protection rules in banking

The risk scenarios UDAAP and Fair Lending create

The hidden simplicity of UDAAP and Fair Lending risk management

The pratfalls of consumer protection

The synergy between Fair Lending, UDAAP and your business goals.

Who will benefit: (Titles)

Board of Directors Members
Executive Officers
Senior Officers
Compliance Officers
Risk Managers
All commercial and consumer Lending Department employees
Bank Operations Managers
Branch Managers

About Speaker

Asaad A. Faquir is currently a Compliance Officer for a growing community bank in New England. He began his career in banking as an Operations and Management Consultant for a large multi-billion dollar bank in South Florida. Asaad has a BS in Finance from Florida State University, an MBA in Finance from Temple University and a Masters Degree in Human Resource Management from the University of Limerick in Limerick, Ireland where he focused his Masters Thesis on Strategic Leadership, while attending school as a Rotary International Ambassadorial Scholar. Asaad has conducted successful webinars in the areas of risk and compliance and has been an Adjunct Professor of Human Resource Management.

Description

Overview: Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.

Areas Covered in the Session

- FDA and ISO requirements for complaint handling

- Establishment of complaint handling program

- What constitutes a complaint

- ISO-specific implications of complaint handling

- The roles of investigation and corrective action in complaint handling

- Complaint trending and reporting

- Application of risk management to complaint handling program

Who will benefit: (Titles)

This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

· Regulatory Management

· QA Management

· Customer Service Personnel

· Sales Personnel

· Quality System Auditors

· Consultants

About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

Description

The HIPAA rules for Privacy and Security of Protected Health Information are undergiong significant expansion, with new requirements, fines, and penalties, and a new enforcement effort.

Why should you Attend:

The HIPAA privacy and security regulations are changing in ways that affect every health care-related entity, from providers to insurers to business associates, and more. The HIPAA Privacy and Security Regulations have been modified in regulations issued as interim final rules (IFRs) and notices of proposed rule making (NPRMs) by the US Department of Health and Human Services (USDHHS).

• All kinds of covered entities, and now, business associates of covered entities and their subcontractors as well, need to review their HIPAA compliance, policies, and procedures to see if they are prepared to meet the changes in the rules. Some subcontractors of business associates may not even be aware that they handle protected health information and now fall under the regulations.

• A whole range of new regulations around the release and accounting of electronic records have created new burdens that your EHR and your medical records department must deal with.

• Not only are the compliance rules changed, but the enforcement rules have changed, with a new four-tier violation schedule with increased minimum and maximum fines, and mandatory fines for willful neglect of compliance that start at $10,000 even if the problem is corrected within 30 days of discovery. Violations that are not promptly corrected carry mandatory minimum fines starting at $50,000 and can reach $1.5 million for any particular violation. And any reports of willful neglect are required to be investigated under the law. Even violations for a reasonable cause or with reasonable diligence taken are subject to penalty.

• Whereas the former practice of USDHHS has been to audit compliance only in instances where a violation was reported, the law now requires USDHHS to conduct a regular HIPAA compliance audit program, and soon those individuals harmed by a violation will have the right to a share in any settlements or penalty collections. The new audit program is already getting under way.

• With the far reaching changes in the rules and the new enforcement and penalty levels, it’s never been more important to review your HIPAA compliance and meet the new requirements.

Description of the topic:

• New regulations modifying the HIPAA Privacy and Security Regulations have been proposed and/or finalized to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. New requirements for business associates of HIPAA covered entities and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restricting and accounting of disclosures and increased enforcement activity.

• All kinds of covered entities, and now, business associates of covered entities and their subcontractors as well, need to review their HIPAA compliance, policies, and procedures to see if they are prepared to meet the changes in the rules. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules and all kinds of business associates and their subcontractors will need to establish compliance programs.

• And the regulations include new requirements for audits by the US Department of Health and Human Services and mandatory penalties in the event of willful neglect of the regulations.

• This teleconference will help health information professionals understand what they have to do, and when, and what to keep in mind as they move forward, in order to be prepared for compliance with the new regulations. It will provide a comprehensive look at the changes in the law and prepare attendees for the process of incorporating the changes into how they do business in their facilities.

• Business associates are now directly covered by the HIPAA privacy, security, and breach notification regulations and are liable for fines and penalties if they do not comply. In addition, there are new kinds of businesses that are considered to be business associates, such as Health Information Exchanges and e-Prescribing Gateways,as well as patient safety organizations and any subcontractors of business associates, putting thousands of businesses under regulation that were not regulated before now. We will explain what a Business Associate needs to do differently under the new regulations, including providing a policy framework for information security.

• Penalties for violations have been increased, including a new, four-tier penalty structure and new mandatory penalties for willful neglect that begin at a minimum of $10,000 and can go up to $1.5 million or more. The definitions of the penalty levels include new definitions for reasonable cause and reasonable diligence, as well as willful neglect, which have a direct impact on the amount of penalty a violation may be subject to.

• Electronic records have new demands placed on them, in both providing access and in accounting for all disclosures of health information – the electronic age in health care brings new obligations to serve individuals as well as manage health information for healthcare professionals. We will discuss how disclosures must be tracked in an EHR and review the various ways patient records can be supplied electronically.

• The new regulations will be reviewed and their effects on usual practices will be discussed, as will what policies need to be changed and how. We will show what policies and evidence you need to produce if you are audited by the HHS Office of Civil Rights. Now that there is a legislative mandate to audit compliance, and a random audit plan under development, you need to be prepared to respond to audit requests.

Areas Covered in the Session:

The new regulations change the way individuals have access to their records, and how much they can find out about who has accessed their records.

Individuals can now request certain restrictions on disclosures that you must honor.

There are new requirements for disclosers of health information to apply “minimum necessary” standards.

Business Associates have new requirements to comply with HIPAA privacy protections and security safeguards and are subject to enforcement and penalties directly by HHS.

Health Information Exchanges, Regional Health Information Exchanges, and e-Prescribing gateways are now considered to be Business Associates

New limitations on marketing and fund-raising may change how entities can reach out to individuals.

New audit and penalty requirements increase the need to make sure you are in compliance before HHS OCR knocks on the door.

o Learn how changes to HIPAA came to pass

o Find out the details of the changes to HIPAA, including new definitions

o Understand how the changes affect your organization

o Plan for implementing new requirements

o Learn how to attain compliance

o Find out about new penalties and enforcement of HIPAA

o Discover the Changes to HIPAA Practices in the areas of:

A. Business Associates

B. Breach Notification

C. Accounting of Disclosures

D. Restriction of Disclosures

E. Enforcement, Audits, and Penalties

Who will benefit

Compliance director

CEO

CFO

Privacy Officer

Security Officer

Information Systems Manager

HIPAA Officer

Chief Information Officer

Health Information Manager

Healthcare Counsel/lawyer

Office Manager

Contracts Manager

About Speaker

Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a variety of health care providers, businesses, universities, small and large hospitals, urban and rural mental health and social service agencies, health insurance plans, and health care business associates. He serves on the HIMSS Information Systems Security Workgroup, has co-chaired the Workgroup for Electronic Data Interchange Privacy and Security Workgroup, and is a recipient of the 2011 WEDI Award of Merit. He is a frequent speaker regarding HIPAA and information privacy and security compliance issues at seminars and conferences, including speaking engagements at AHIMA national and regional conventions and WEDI national conferences, and before the New York Metropolitan Chapter of the Healthcare Financial Management Association, Health Information Management Associations of Virginia, New York City, New York State, and Vermont, the Connecticut Hospital Association, and the Hospital and Health System Association of Pennsylvania. Sheldon-Dean has nearly 30 years of experience in policy analysis and implementation, business process analysis, information systems and software development. His experience includes leading the development of health care related Web sites; award-winning, best-selling commercial utility software; and mission-critical, fault-tolerant communications satellite control systems. In addition, he has eight years of experience doing hands-on medical work as a Vermont certified volunteer emergency medical technician. Sheldon-Dean received his B.S. degree, summa cum laude, from the University of Vermont and his master’s degree from the Massachusetts Institute of Technology.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

Description

Since 1984, the FDA has identified lack of design controls as one of the major causes of device recalls.

The SMDA provided the FDA with the authority to add preproduction design controls to the device GMP regulation.

The design control requirements are not intended to apply to development of concepts and feasibility studies.

Preamble #62

FDA will evaluate the process, the methods, and the procedures that a manufacturer has established to implement the requirements for design controls.

The FDA has amended the IDE regulation, reaffirming that an IDE device is exempted from complying with the GMP’s … with the exception of Sec. 820.30 “Design Controls.”FDA will not inspect design controls during bioresearch monitoring inspections.The concept of an environmental management system evolved in the early nineties and its origin can be traced back to 1972, when the United Nations organised a Conference on the Human Environment in Stockholm and the United Nations Environment Programme (UNEP) was launched (Corbett & Kirsch, 2001). These early initiatives led to the establishment of the World Commission on Environment and Development (WCED) and the adoption of the Montreal Protocol and Basel Convention.

In 1992, the first Earth Summit was held in Rio-de-Janeiro (Jiang & Bansal, 2001), which served to generate a global commitment to the environment (RMIT University). In the same year, BSI Group published the world's first environmental management systems standard, BS 7750.[1] This supplied the template for the development of the ISO 14000 series in 1996, by the International Organization for Standardization, which has representation from committees all over the world (ISO) (Clements 1996, Brorson & Larsson, 1999). As of 2010, ISO 14001 is now used by at least 223 149 organizations in 159 countries and economies.

Why should you Attend

In the global economy and supplier partnership, it is critical that every product development process for product, service or logistics, is well design - that the design inputs are well defined, design outputs are documented and auditable as well as design transfers are successful. There are millions of dollars spent on design transfers that are not effective - and instead of creating a benefit and remove liability, they instead increase the liability and risk. They have been number of FDA finds and warning letters issued against the design control processes to all sizes of medical and pharmaceutical manufactures. This topic is becoming ever increasing as we are being pressured to design faster, transfer faster, make faster yet never compromised quality, compliance, risk, or profit.

Areas Covered in the Session:

- Medical Device, FDA & CFR

- Design Control Introduction

- Design & Development Planning

- Design Input

- Design Output

- Design Review

- Design Verification

- Design Validation

- Design Transfer

- Design Changes

- Design History File

Who will benefit:

- Quality Managers

- EHS managers

- Small business owners

- CAPA investigators

- Project managers

- Product development engineers

- Consultants

Free Handouts: Medical Device, FDA & CFR

Meet You Speaker:

Salim Khan: He holds a master degree in Manufacturing Engineering, an MBA and BS in Mechanical Engineering. He is also ASQ certified Six Sigma Black Belt, Certified Reliability Engineer, Certified Quality Engineer. Salim has successfully implemented several design control and risk management processes for medical device companies. He also has extensive experience in developing efficient product development process. He enjoys statistics and has completed several process validations.

About Speaker

Jasmin NUHIC serves a major medical devices OEM as a Sr. Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

description

Attendees will receive free document on Review of ISO14001 standard; review of ISO 9001 standard - learn similarities nd differences.

"The ISO 14000 environmental management standards exist to help organizations minimize how their operations (processes etc.) negatively affect the environment (i.e. cause adverse changes to air, water, or land); comply with applicable laws, regulations, and other environmentally oriented requirements, and continually improve in the above.

The concept of an environmental management system evolved in the early nineties and its origin can be traced back to 1972, when the United Nations organised a Conference on the Human Environment in Stockholm and the United Nations Environment Programme (UNEP) was launched (Corbett & Kirsch, 2001). These early initiatives led to the establishment of the World Commission on Environment and Development (WCED) and the adoption of the Montreal Protocol and Basel Convention.

In 1992, the first Earth Summit was held in Rio-de-Janeiro (Jiang & Bansal, 2001), which served to generate a global commitment to the environment (RMIT University). In the same year, BSI Group published the world's first environmental management systems standard, BS 7750.[1] This supplied the template for the development of the ISO 14000 series in 1996, by the International Organization for Standardization, which has representation from committees all over the world (ISO) (Clements 1996, Brorson & Larsson, 1999). As of 2010, ISO 14001 is now used by at least 223 149 organizations in 159 countries and economies

Description of the Topic:

Overview of the regulation, its benefits to organizations, elements of auditing for ISO 14001, training requirements, awareness, and implementation, some of the lessons learned and most commonly asked questions.

Areas Covered in the Session

- Overview of the standard

- Implementation tips and suggestions

- Benefits of implementation and compliance

- Auditing elements related to ISO 14001

- Increasing awareness and communications

- Lessons learned

Who will Benefit

- Quality Managers

- EHS managers

- Small business owners

- CAPA investigators

- Project managers

- Operations managers

- Consultants

- Review of ISO14001 standard; review of ISO 9001 standard - learn similarities and differences

About Speaker

Jasmin NUHIC serves a major medical devices OEM as a Sr. Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696
https://www.compliance2go.com/index.php?option=com_training&speakerkey=8...