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

New 21 CFR Part 11 regulations and how to comply with them.

Why should you Attend

With the growth of the Pharmaceutical and Biotechnology industry, audits get more and more frequent. The complexity of the investigational products and of the clinical trial protocols amplified the risks for noncompliance. Noncompliance in clinical trials and misreporting of clinical trial results that took place in the last years made the regulatory bodies to multiply the number of audits. On the other part, the sponsors also multiplied the audits from their part in the idea to try to downsize the risk of noncompliance during the trial. This presentation will help with preparing the site and the study team with how to comply with the new 21 CFR part 11 regulations, how to identify risk of noncompliance, and how to insure compliance.

Areas Covered in the Session

Learning about preventing noncompliance during the clinical trial development and about preparing well for an audit.

Who will Benefit: (Titles)

Clinical trial sponsors study team
CROs study team
Study managers
Clinical team leads
CRAs
Principal investigators, site managers and study coordinators
IT and Data Managers

About Speaker

Calin Enea Popa, MD, CCRA is the Founder and President of Advanced Clinical Research Service Inc. a Canadian clinical research consulting company that provides training to FDA and Health Canada regulated industries. He provides ICH-GCP training and training for FDA and Health Canada regulations. He conducted visits for Pre-Study Site Qualification, Initiation, Monitoring and Close-Out for the purpose of compliance review, drug accountability, site management, safety review, training site personnel, and to assure the integrity of clinical data. Conducted visits to train new CRAs (sign-off visits) and performed online training for CRAs and site staff regarding regulatory compliance and Electronic Data Capture. He works close wih companies and sites to prepare them for audits. He holds the CCRA certification from and is an active member of the Association of Clinical Research Professionals.

Excel Spreadsheet Compliance with 21CFR11

Description

This course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

Why should you Attend
Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environments.

Areas Covered in the Session

1. Requirements for Excel Spreadsheets
2. FDA Part 11 Validation Guidance
3. Compliance Problems with Spreadsheets
4. Design Specifications for 21 CFR 11 compliance
5. How does the FDA Design and Use spreadsheets
6. Documentation for Part 11
7. Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

Who will Benefit

• Quality Managers
• Quality Engineers
• Small business owners
• Internal and external auditors
• Management Reps
• FDA inspectors
• Consultants
About Speaker
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years experience in the Life sciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and teaches classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management. More recently, Ms. Bazigos was selected to co-author Computerized Systems In Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia

Price List: Live : $189.00 Corporate live : $499.00 Recorded : $249.00, CD:$299.00

For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

https://compliance2go.com/index.php?option=com_training&speakerkey=13&pr...

Description

More health care providers than ever are adopting electronic health records, and new regulations on using them and protecting the information on them are here, with more on the way.

Why Should You Attend:

• Recent and proposed changes to HIPAA that expand the regulation’s reach and increase enforcement, along with incentives to adopt electronic health records, have created a perfect storm for the privacy and security of protected health information (PHI).

• Many of the new changes to HIPAA focus directly on aspects of the use of electronic records, such as the accounting of disclosures of all kinds, even for treatment, payment, and healthcare operations, and the provision of records in electronic formats when requested. These proposed rules have a tremendous impact on not only EHRs, but any electronic systems that hold protected health information in the designated record set.

• The proposed requiement to provide a list of all accesses of an individual records is based on an ability to track accesses that not all systems can provide today. Using electronic records of any kind could mean big headaches for compliance with HIPAA accounting of disclosures requirements.
• To qualify for incentive funding, providers must perform HIPAA Security compliance activities that may have been sidestepped in the past, but no longer can be due to new, higher penalties, including mandatory penalties in the tens of thousands of dollars for willful neglect of compliance. Risk analysis is now clearly required, both for HIPAA and for EHR funding, but many organizations have not yet performed one and find the task overwhelming.

• Providers will need to change how they do business to meet the new requirements as they move to newer electronic records systems, and qualifying for the funding will require the kind of attention to privacy and security that health information has always deserved, but not always received.

Description of the topic

The new and proposed HIPAA Privacy and Security regulations will be reviewed and their effects on the use of EHRs will be discussed. The proposed rules call for an ability to make an electronic copy of an individual's protected health information for any information held in an entity's designated record set. In addition, any accesses of electronic PHI in a designated record set must be recorded so that they can be provided in an access list if requested by the individual. Not only do these requirements call for technical capabilities that may or may not be present in a particular system, but they also imply that an organization would be well-advised to carefully define its designated record set in order to limit its exposure under these requirements, giving the definition of a designated record set new importance.

We will discuss how disclosures and accesses must be tracked in an EHR and review the various ways patient records can be supplied electronically. The proposed rules allow for a variety of methods to accomplish the objectives, but all will require new policies, procedures, and practices. We will show what policies need to be changed and how.

Adopting an EHR and securing funding for it through the Federal program requires that certain objectives be met according to defined measures, including a required objective to protect the privacy and security of information in an EHR. That measure calls for a HIPAA Security risk analysis. We will discuss the scope and methods of a risk analysis that can meet the requirements and make it easier to prioritize your activities to reduce risks and improve security most cost-effectively.

Some of the new regulations require an ability to restrict certain disclosures that may not be easy to implement in EHRs, and may require modifications and upgrades before you can be in compliance.

To be prepared for compliance, you need to be prepared for an audit by the HHS Office of Civil Rights. This session will show you what policies and evidence you need to produce if you are audited, and what you can do ahead of time to show you have securely implemented your EHR and continue to monitor and maintain its security. We will show you how to find out what has been asked of entities in reviews before and what you need to prepare in advance so you can be ready when they call.

Finally, the new enforcement penalty structure and the latest plans for audits by HHS OCR will be described, so you can know what you're up against if you don't make the effort to ensure compliance. Protecting your EHR will require new practices and new routines to help you avoid breaches and the significant penalties of violations, and we will help you understand the ramifications of not doing what's necessary to protect your EHR and its data, so you can make intelligent decisions about your security priorities.

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 request an accounting of disclosures of their health information including those made for purposes of treatment, payment, or healthcare operations, from an electronic health record, going back three years.

• Individuals have the right to obtain electronic copies of their health information that is stored electronically, from any electronic system in the HIPAA designated record set.

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

• Meaningful Use requirements for EHR funding call for a HIPAA Information Security Risk Analysis and implementation of risk mitigation measures.

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

• The new penalty structure and plans for audits mean that you are more likely to be audited for HIPAA compliance, and you may be facing significantly higher penalties for non-compliance than ever before.

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, and has co-chaired the Workgroup for Electronic Data Interchange Privacy and Security Workgroup. 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 Corporate live : $499.00 Recorded : $249.00, CD:$299.00

For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

https://compliance2go.com/index.php?option=com_training&speakerkey=12&pr...

Description

Enforcement of HIPAA regulations is being stepped up and new fines and penalties make being ready for an audit in advance essential.

Why Should You Attend
• The US Department of Health and Human Services (HHS)is actively developing plans with consulting firm KPMG to meet requirements in the HITECH Act in the American Recovery and Reinvestment Act of 2009 (ARRA) for performing periodic audits of compliance with the HIPAA Privacy and Security Rules. In addition new enforcement is taking place related to the new HIPAA Breach Notification Rule. While in the past, audits had been performed only at entities that had had a compliant filed against them, the new rule calls for audits whether or not there is a complaint. This means that the HHS Office for Civil Rights (OCR) can show up at your door and ask to perform an audit on short notice, and your organization will need to be ready.

• If your organization is not ready, the HIPAA rules have new, significantly higher fines, including mandatory minimum fines of $10,000 for willful neglect of compliance. All HIPAA Covered Entities and Business Associates need to be fully in compliance and prepared for an audit at any time, or risk the significant fines for non-compliance.

• In addition, HIPAA enforcement has taken on a new importance at HHS, as shown in multi-million dollar fines and even a one million dollar settlement for a breach of just 192 records. HHS OCR officials have publicly stated that enforcement is now a priority, and that means being ready for an audit is more important than ever. The "slap-on-the-wrist" days are over and fines and settlements are being levied, with more on the way -- don't let your organization be hit for an audit unprepared.

• By using an information security management process, those responsible for health and payment information can develop the procedures and policies that can help prevent security problems, and help prepare the organization for any incidents, audits, or enforcement actions.

• If you don't take the proper steps to ensure your patients' health information is being protected according to the HIPAA Security Rule, you can be hit with significant fines and penalties. With the increased HIPAA fines beginning at $10,000 in cases of willful neglect, providing good information security and being in compliance are more important than ever.

Description of the topic

In this session we will discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates. We will explain the enforcement regulations and their recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10,000. We will discuss what information and documentation needs to be prepared in advance so that you can be ready for an audit without notice. Sample information request forms and questions asked at prior audits will be presented.

• The session will also cover how to know if you may become the subject of an audit or enforcement action, and what you can do to help limit your exposure. We will discuss how most enforcement actions come about and what can be done to prevent incidents that lead to enforcement.

• The HIPAA Privacy, Security, and Breach Notification regulations (and the recent changes to them) and how they will be audited will be explained. Documentation requirements for compliance will be explored and a framework of security policies necessary for compliance will be presented. Meeting any set of information security requirements always involves conducting a thorough risk analysis to make sure you haven't overlooked any weaknesses. We'll discuss what's involved and how it is the cornerstone of your compliance efforts.

• The results of prior HHS audits (and their penalties) will be discussed, including recent actions involving multi-million dollar fines and settlments. A plan for attaining compliance will be presented. The steps to follow to prepare for an audit and respond to an audit request will be outlined. In addition, upcoming trends in information security risks will be discussed.

Areas Covered in the Session

Fines and penalties for violations of the HIPAA regulations have been significantly increased and now include mandatory fines for willful negligence that begin at $10,000 minimum.

HIPAA Audits have been few and far between in the past, but that's now changing - the HHS will be auditing HIPAA covered entities and business associates even if there have been no complaints or problems reported.

Find out what HHS OCR is likely to ask you if you are selected for an audit, and what you'll have to have prepared already when they do.

Find out what the rules are that you need to comply with and what policies you can adopt that can help you come into compliance.

Learn how the HIPAA rules have changed and how you may need to change how you work to keep up with them.

Learn how having a good compliance process can help you stay compliant more easily.

Find out what you'll need to have documented to survive an audit and avoid fines.

Find out what you'll need to think about to deal with future threats to the security of patient information.

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, and has co-chaired the Workgroup for Electronic Data Interchange Privacy and Security Workgroup. 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 Corporate live : $499.00 Recorded : $249.00, CD:$299.00

For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

https://compliance2go.com/index.php?option=com_training&speakerkey=12&pr...

description

During the webinar, we cover topics and provide examples and share personal experiences related to FDA and ISO 14971, Risk Management Process, Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation, Production and Post-Production, and more. We also provide number of questions and answers and give opportunity to ask specific questions related to the company/environment you serve.

Why Should You Attend

Risk management is NOT an option. It is must in the almost any environment, any industry and/or any company. Mistakes happen. Erros happen - both planned and unplaned for. Leearning is continuous. All more reasons to be better prepare to handle them and act on them to keep patients, doctors, machinist, operators, nuerses safe and companies healthy and profitable. Understanding risk management in medical devices is a must do for any professional serving medical industry in any format. Furthermore, risk management is a just good business sense as it tends to improve product reliability and durability and by that minimize warranty costs, recalls, bad press and more. Finally, ISO 14971 promotes good practices and processes necesary to ensure proper risk management is put in place - and it is effective. For all this and more, join us for this webinar and learn from our experiences, examples, as well as from the research we conducted in the area of risk management for medical devices.

"Attendees will receive free document - ISO 14971 and specific elements of FDA regulations"

Who Will Benefit

Quality Manager
Quality Engineers
Product Developers
Internal and external auditors
Management Reps
FDA inspectors
Consultants

About Speaker

Experience in regulated (FDA) industry with vast experience in quality management systems, manufacturing and concurrent engineering, quality auditing, quality controls, supplier quality, supplier management, project management, training and management information systems (including development). Proven and verifiable track record in continuous improvement and cost saving initiatives (resulted in hundreds of thousands of dollars in savings and improved lead time). Enjoy leading teams, working with others and teaching part-time at a University.

https://www.compliance2go.com/index.php?option=com_training&speakerkey=5...

Summary
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

Details

Discount : Get 15 % Discount as a early bird registrations. Use Promocode CGO15

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.

https://www.compliance2go.com/index.phpoption=com_training&speakerkey=11...

Summary
This Medical Device training will be discussing the newly-updated requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the European requirements for CE Marking and ISO Certification on commercializing products. The history, current processes and latest regulatory environment on all Classes of Medical Devices and Combination Products will be discussed. Learn how to classify your product and how that classification translates to the required data needed to CE mark your product across the EU. You will also be updated on the recent and contemplated changes coming on the EU Medical Device Directives.

Details

Discount : Get 15 % Discount as a early bird registrations. Use Promocode CGO15

Why Should You Attend: This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics in brief associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation.

Key Topics to be Discussed:

The current regulatory situation in relation to Medical Devices in the EU.
The purpose of the Medical Device Directives.
Meeting the New Requirements for Conformity Assessment by Product Type.
Understanding the impact the Directive will have on developing and marketing new Medical Device products.
An overview of key areas of the Directive:
Scope of application and definition
Essential Device Requirements
Medical Device Type & Process Path
Medical Device Technical File
Clinical Investigation Requirements
Clinical Evaluations
Notified Bodies involvement
Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.
Detailed Agenda of the Session:

Definition: Medical Device or Personal Protective Equipment.
Overview of the Global Medical Device Industry
Standard
Active Implanted
In Vitro Diagnostic
Combination Products; Drug or Biologic + Device- Interface with Other Directives and How It’s Treated from a Regulatory Perspective
An Overview of the Medical Device Directives.
Development, aims, implementation and update of the Medical Device Directives
Implication of an EU Directive vs. Regulation
Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combination Products
Update on the additional guidance documents relating to the directives
Essential Requirements
Classification of MD's and Process Implications
Conformity Assessment
Technical File
Relationship to EU Clinical Trial Directive
Guidance Documents.
Medical Device Directive Annexes.
Compliance Requirements by Type
Full Quality Assurance System
Declaration of Conformity
Safety.
Medical Device Vigilance System
Manufacturer's Requirements
GMP
GCP
CE Marking
ISO Certification
Clinical Trials
Labeling
ISO Standard Certification.
Overall process; Management Commitment & Involvement
Role of Notified Bodies
Relationship to CE Marking
ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International Standards
ISO-14155 Medical Device Clinical Investigations.
Part I- Clinical Studies
Part II- Clinical Investigations
Linkage to EU Clinical Trial Directive; What Does & Doesn't Apply
Compare & Contrast EU & FDA Procedures and Requirements.
Process Similarities & Differences
Implications for Industry
Company Management
Process Changes
Management Team Effectiveness
Regulatory Approval and Liaison with Regulators.
EU Co-Decision Procedure
Committees, Working Parties Relevant for Medical Devices
When and How to Influence Regulators
Do's and Don'ts of Regulatory Involvement
Individual Company Involvement vs. Trade Association

Learning Objectives:

Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices across the European Union. The Directives are complex and the requirements differ somewhat by Member State. The content of this course is designed to simplify the understanding of all requirements and to provide attendees with the latest information regarding interpretation and enforcement of these regulations.

Who Will Benefit:

This workshop will be of great value to Medical Device professionals and those involved in the registration of Medical Devices across the EU. It is primarily designed to benefit the following disciplines:

Clinical research and medical operations
Project Managers
Product Development personnel
Manufacturing personnel
Researchers managing Medical Device R&D and Development
Quality Assurance such as GMP, GCP Auditors
Regulatory affairs
Clinical trial supply personnel
CRO personnel
All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (30 expanded EEA countries)

About the 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.

https://www.compliance2go.com/index.phpoption=com_training&speakerkey=11...