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Associates Training Seminars and Classes

From Requirements Solutions Group

How to Plan Business Analysis Activities and Manage Risks

Planning business analysis activities is often perceived as a project manager responsibility. Indeed, what makes the business analysis activities of a project any different than any other activity? Because study after study indicate that missed or misunderstood requirements are the number one cause of project failure, paying special attention to these critical areas would seem to be a good idea. more...

From GlobalCompliancePanel

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities

...the regulations that require them. The role of business associates who maintain or support your EHR will be discussed, and the extension of the accounting out to them by way of their use of Designated Record Set data will be explored, including potential necessary changes to business associate agreements. Learn how the new regulations change the way individuals have access to their records, more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...esses 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 more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel Overview: The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing of the "Principles of GCP" and a definition that is more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP Overview: The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel ... 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 more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ..., 2009, requiring all HIPAA covered entities and business associates to follow a number of steps to be in compliance. * The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We will discuss the origins of the rule and how it works, including interactions more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel Overview: This presentation will go over the steps required for your recruiting process to be successful. The ability to bring in (recruit) on-time study participants whether they be 'normal healthy adults' or patients with the condition being studied is essential for a CRO, a site, a CPU/ CRU for conducting on-time study starts with the full complement of volunteers. For this reason the more...

Hazard Analysis vs FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel Overview: The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. The presentation will explain both methodologies and will show ways how these tools can be used to complement more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel Overview: This presentation will explore FDA Corrective Action and Preventive Action findings in medical device manufacturer quality systems to determine FDA's concerns. The FDA and ISO 13485 requirements for CAPA will be reviewed to identify how procedures may define a compliant CAPA system. Implementation and maintenance of the CAPA system will be explored. FDA indicates that CAPA systems more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel Overview: In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...fect in 2011, calls for all Covered Entities and Business Associates, and their subcontractors, to be in compliance with provisions protecting all kinds of electronic protected health information. While many entities have gone through the processes necessary for HIPAA Security Rule compliance, many are only partially in compliance and have not performed all the steps necessary for compliance. more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel Overview: This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel Overview: In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs). Why you should attend: Quality assurance is defined as a "systematic and independent examination of trial-related activities and documents" that allows more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...einvestment 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 more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane Overview: This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result more...

The HITECH Acts Impact on HIPPA - Webinar by GlobalCompliancePanel The new requirements of the HITECH Act have a significant impact on the privacy and security of health information. This webinar will cover the changes required by the HITECH Act and the actions that needed to taken regarding breach notification, business associate contracts, training of staff and security of PHI for business associates. We will also discuss the best practices for data more...

From Total Medical Compliance

HIPAA Webinar for Business Associates

... clients, TMC created a program specifically for Business Associates. Not just for health care practices, but many of the other companies that work with these practices and have access to their patients' protected health information, or PHI. A few BA examples include such vendors as: debt collectors, medical transcriptionists, IT/ software, and lawyers in some scenarios This is a HIPAA more...

HITECH Changes Business Associates Marketing Restrictions and more New information is available in this hour-long webinar, from the proposed regulations that were published July 14, 2010 up to and including the current proposed HIPAA changes. This is an informative and fast-paced webinar. Debra Gordick, who facilitates this webinar, is TMC's in-house HIPAA guru and her presentation of HITECH Changes is not to be missed. more...

From Procept Associates Limited

PRINCE2 Foundation and Practitioner

...reg; training is delivered in association with Raj Khanna Associates Limited, who are an Accredited Training Organisation for APMG UK. Both are APM Group Ltd (APMG) Accredited Courses that covers the elements contained in the APMG Syllabus for the PRINCE2 (PRojects IN Controlled Environments) Foundation and Practitioner Course. The live virtual instructor led PRINCE2 ® program is more...

From Business Expert Webinars

Use Customer Service to Win Loyal Clients ...xperience strategy book, and is owner of Susan Hoekstra & Associates, a service consulting firm focused on the client experience. Susan is an experienced senior manager, customer service presenter, trainer and client experience consultant who spent the past 25 years working with multi-sized, fast-paced, highly volatile companies in various industries. Over the years, she has developed a more...

Advanced Customer Service Planning for Services Firms ...xperience strategy book, and is owner of Susan Hoekstra & Associates, a service consulting firm focused on the client experience. Susan is an experienced senior manager, customer service presenter, trainer and client experience consultant who spent the past 25 years working with multi-sized, fast-paced, highly volatile companies in various industries. Over the years, she has developed a more...

Customer Service for a Social Media World ...xperience strategy book, and is owner of Susan Hoekstra & Associates, a service consulting firm focused on the client experience. Susan is an experienced senior manager, customer service presenter, trainer and client experience consultant who spent the past 25 years working with multi-sized, fast-paced, highly volatile companies in various industries. Over the years, she has developed a more...

Profitability Strategies for Service Firms Find the cost sinkholes that are draining your profits Business leaders in service firms are under enormous pressure to find opportunities to reduce costs. While you have already undergone a round of cost-cutting, the cuts did not produce the expected results to the bottom-line. The company is relying on you to create cost reduction strategies without damaging the brand, but you've exhausted more...

Unconventional Marketing Strategies for Small Business Owners Boost revenue and profit in this stressed economy Small business owners are struggling now more than ever to grow revenue. Cash flow is limited and return on investment (ROI) dictates where this money is spent. You need to question where to invest marketing dollars how to measure performance and what to expect from ROI. Your marketing budget must be invested wisely or you will suffocate your more...

How to Handle Customers Who File for Bankruptcy ...tor and Senior Consultant at Commercial Credit Management Associates, LLC (CCMA) and the founder of the company. Mr. Philbin's entire working experience totalling 35 years has been solely in Corporate Credit & Collections Management to which he has distinguished himself as a leader in numerous industries. Mr. Philbin has obtained the coveted designations as Certified Credit Executive (CCE) from more...

Use Customer Service to Win Loyal Clients ...xperience strategy book, and is owner of Susan Hoekstra & Associates, a service consulting firm focused on the client experience. Susan is an experienced senior manager, service presenter, trainer and consultant who spent the past 25 years working with multi-sized, fast-paced, highly volatile companies in various industries. Over the years, she has developed a penchant for developing service more...

Customer Service for a Social Media World ...xperience strategy book, and is owner of Susan Hoekstra & Associates, a service consulting firm focused on the client experience. Susan is an experienced senior manager, service presenter, trainer and consultant who spent the past 25 years working with multi-sized, fast-paced, highly volatile companies in various industries. Over the years, she has developed a penchant for developing service more...