Globalcompliancepanel Successfully Completed Seminar in Los Angeles -New FDA FSMA Rules

New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

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Globalcompliancepanel Successfully Completed Seminar in Philadelphia-Design of Experiments and Statistical Process

Design of Experiments and Statistical Process Control for Process Development and Validation

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An understanding of HIPAA upcoming changes for 2016

Professionals at various levels of the healthcare industry need to have a grasp of the HIPAA Security/Privacy Rule and the way it relates to their practice or business. A two-day, in person, live seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will offer this very important understanding.

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Brian Tuttle, a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), and Certified Business Resilience Auditor (CBRA) , who brings over 15 years’ experience in Health IT and Compliance Consulting, will be the speaker at this seminar. Please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900727SEMINAR to enroll for this highly educative session.

A host of areas relating to HIPAA and changes for 2016

Among the areas that Brian will take up are the changes under the Omnibus Rule and any other applicable updates for HIPAA for 2016. There are an enormous amount of issues and risks that Covered Entities and Business Associates these days. He will also dwell upon other aspects of HIPAA, such as:

  • The history of HIPAA
  • Privacy vs. security,
  • Business Associates,
  • Changes for 2016
  • Audit process
  • Paper-based PHI
  • HIPAA and suing
  • Texting
  • Email
  • Encryption
  • Medical messaging
  • Voice data, and lots more.

Myths vs. realities of HIPAA

Essentially, Brian will explain myths versus reality as it relates to this very enigmatic law, and this clarification will be based on over 1000 risk assessments he has performed during the many years of experience he gained in dealing directly with the Office of Civil Rights HIPAA auditors during his career.

Understanding the risk factors for being sued for wrongful disclosures

He will also speak of real life audits conducted by the Federal government and help participants understand what their highest risks are for being fined. He will discuss the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using State laws to sue for wrongful disclosures.

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He will offer an explanation of the multiple litigated cases that he has been a part of involving HIPAA situations. He will also thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information and demonstrate how to limit those risks by simply taking proactive steps and utilizing best practices.

Brian will cover the following areas at this seminar:

  • History of HIPAA
  • HITECH
  • HIPAA Omnibus Rule
  • How to perform a HIPAA Security Risk Assessment
  • What is involved in a Federal audit and how is it conducted
  • Risk factors for a federal audit
  • EHR and HIPAA
  • Business Continuity/Disaster Recovery Planning
  • Business Associates and HIPAA
  • In depth discussions on IT down to the nuts and bolts
  • BYOD
  • Risk factors that can cause an audit (low hanging fruit)
  • New rules which grant states ability to sue citing HIPAA on behalf of a patient
  • New funding measures.

 

Getting Design of Experiments and Statistical Process Control right for Process Development and Validation

Procedures must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. Why this needs to be done is because the FDA has, in a recent guidance document on Process Validation, assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality Unit.

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Going about doing this work requires a practical orientation. It calls for an approach with case studies and examples. A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will provide just this and fulfill this requirement.

Dr. Steven Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the Director at this two-day session. To enroll for this valuable session, please register by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900701SEMINAR. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

An interactive session

Dr. Kuwahara will offer theoretical information introduced only when necessary to understand an experiment. A highly interactive and practical session; this seminar offers examples from real processes and testing procedures and present the participants with examples that will be directly applicable to their work.

For any pharmaceutical worker who performs, supervises or reviews manufacturing or testing processes, an understanding of the relationships among the process parameters and the ability to monitor the performance of processes and test methods are necessary. This is all the truer of the worker in Quality Control and Quality Assurance in view of the recent FDA guidance document on Process Validation.

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This work, however, is done by the development, manufacturing, or quality systems worker. So, synchrony between these two levels of employees is needed. This course will equip these two levels of employees with the knowledge of how to design the systems and studies, and interpret the results generated.

Getting design controls right is absolutely essential for medical device companies

Design Controls are absolutely essential for ensuring the safe and effective production of medical devices. The FDA too considers design Controls a critical process. Yet, design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA. Although intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase; a significant percentage of all medical device recalls are due to design problems, as statistics show.

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The implications of poor design of medical devices controls are quite obvious:

  • They account for a significant number of recalls
  • Design issues can result in complaints and medical device reports
  • Design issues can even create manufacturability issues such as low yields and excessive scrap and rework, for companies.

Get an understanding of the solutions and the ways of implementing them

So, the solution to this problem is to find and fix issues early on in the design process. This is a much more effective and inexpensive alternative to fixing problems for products already in production.

The ways of ensuring a trouble-free design control process will be taught at a seminar being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory compliance areas.

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The Director at this seminar is Susanne Manz, an accomplished leader in the medical device industry, who emphasizes quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900629SEMINAR to enroll for this seminar.

A valuable all-round learning session

Susanne will help participants understand and develop design controls processes and tools that are compliant with the regulatory requirements and are a competitive strength for their organizations. She will help them learn from past issues and improve their next generations of product.

She will help participants understand the requirements for design controls and how to translate them into an efficient and effective process for their organizations. She will start with the history and requirements for design controls. She will then move on to a discussion of the requirements and tools in detail. This seminar will include exercises to help participants practice and improve their design control process.

The following areas will be covered at this seminar:

  • Expectations
  • Regulations
  • Process
  • Lessons Learned
  • Myths
  • Challenges
  • Best Practices
  • Inspection Readiness.

Extracting Information from Geochemical Data

Going beyond just asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis is an approach strongly recommended by most mining specialists. There exist other methods of geochemical data analysis techniques and obtaining geochemical extracting information, but these are largely ignored by the industry.

Making sense of the geochemical extracting information

How to make sense of the geochemical extracting information is the core of a webinar that is being organized by GlobalCompliancePanel, a well-known provider of professional trainings for all the areas of regulatory compliance. The speaker, Ricardo Valls, is a professional geologist with thirty years in the mining industry. With extensive geological, geochemical, and mining experience, managerial skills, research techniques, and training; he has carried out various projects globally.

To know more about how to gain knowledge of geochemical extracting information, just visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900826SEMINAR to register.

An understanding of all types of analyses

Richard will give participants an understanding of all the types of analyses that can be requested to help them in their exploration goal –that of finding the new ore body. He will help mining professionals who need to make important decisions on where to drill or how to manage their exploration budget. The speaker will also offer an understanding of how to extract all the important information of data, including the use of compositional data analysis.

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In this webinar, which will be highly educative for a number of professionals in mining, such as Senior Geologists, Geochemists, Exploration personnel, Laboratory personnel, Managers, graduate students, postgraduate students and QA&QC personal; Richard will cover the following areas:

  • How to determine the type of sampling
  • How to determine the type of assays
  • General processing of the data
  • Compositional Data Analysis
  • Representing the results.

Ways of conducting a hassle-free internal and supplier audit for medical devices

Carrying out efficient and effective internal and supplier audits that meet all the requirements of external auditors is a must for medical device manufacturers. These audits should not only serve this purpose; they should also add value to the medical device organization.

Part of both ISO 13485 and QMS

Internal audits are required as part of ISO 13485 and the FDA’s Quality System Regulation (QMS). However, these procedures are quite complicated for many professionals in the medical device industry.  They are often confusing and cumbersome, mainly because of the jargon and regulatory language they contain. Many organizations find it difficult to get the import of these words while wading through them all the way to a successful internal audit.

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A tad complicated

Another couple of complicating factors come into play: Since the FDA does not look at the content of internal audits; many medical device organizations do not get feedback on the true effectiveness of their internal audit system from the FDA during the time of FDA inspections.

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Secondly, while on the other hand ISO 13485 auditors do look at internal audits; they are most concerned with the process. For them, a proper definition of a process that meets the requirements of the standard and the assurance that the company is following these are more important than anything else.

Auditor training is necessary

Both these regulations require that the medical device manufacturer define Auditor training. But there is a catch, because auditor training sometimes just requires reading the company’s procedure, while most external auditors will look for more than this.

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How does a medical device company extricate itself out of this quagmire? The solution to all these vexing questions will be offered at a two-day seminar from GlobalCompliancePanel, a globally known provider of regulatory compliance trainings.

At this seminar to enroll for which you need to just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900601SEMINAR; the Director, Betty Lane, who is Founder and President, Be Quality Associates, LLC, will explain all the issues relating to these aspects of external and internal supplier audits, in a way that is comprehensible and easy to implement.

In the process of explaining what makes for efficient and effective internal and supplier quality systems auditing for medical devices; she will also offer an explanation of best practices for creating and managing a value-added auditing process that will meet both company business needs and regulatory requirements.

At this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion; Betty will get participants to review all the quality management system requirements of FDA and ISO 13485 and then allow them to learn how to set up and manage an audit system that complies with these requirements, yet is risk-based so that their organization makes the most efficient use of auditing resources for both internal and supplier audits.

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She will also include interactive exercises at this two-day session, which will help to strengthen the fundamentals of conducting and documenting quality system audits. The auditing principles taught in this seminar will be based on ISO 19011:2011 Guidelines for auditing management systems.