Adherence to GMP is absolutely essential for Quality Control and Contract Laboratories

It is absolutely essential for contract laboratories to maintain the required standards of Quality Control because of the risk their process involves: After testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check.

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This fact is the primary reason for which regulatory agencies such as the FDA, EMA and many others place the highest emphasis and priority on inspections of QC laboratories. This is also one of the main reasons for which a huge number of QC related 483’s and Warning Letters get issued to companies that have problems with their implementation, despite the existence of cGMP regulations for a long time.

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Helping to understand and imbibe GMP

A complete understanding of GMP for Quality Control and contact laboratories will be offered at a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing. Dr. Ludwig Huber, Chief Advisor – Global FDA compliance at Agilent Technologies, will be the Director at this seminar.

To gain the benefit of this learning, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900698SEMINAR. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The regulatory background and guidelines

At this highly interactive two-day seminar, Dr. Huber will offer to participants the regulatory background and guidelines needed for all critical areas of GMP compliance. He will update them with the latest requirements of this compliance document, which will help them understand and implement these.

As a result of the learning gained at this two-day course, participants will be able to:

  • Learn about the regulatory background and GMP requirements for quality control and contract laboratories
  • Understand and be able to explain their company’s quality plan or laboratory compliance master plan
  • Understand the difference between GMP and non-GMP laboratories
  • Learn how to develop inspection ready documentation
  • Be able to train others in their organization on GMP requirements
  • Learn how to avoid and/or respond to the FDA inspectional observations and Warning Letters.

A practical session

In addition, the Director will also be providing participants with templates and examples with which they can develop inspection-ready documentation. Another of the highlights of this session is that practical examples and interactive exercises will be sprinkled into and between the presentations, with half of the duration of the seminar being dedicated for practical sessions.

Taking the interactive element a step further, Dr. Huber will arrange participants into small groups for the purpose of discussing case studies and prepare the answers using prepared fill-in templates. Yet another bonus of this session is that after the course, Dr. Huber will make a large variety of tools such as SOPs, validation examples and checklists readily available on a dedicated website so that those who have attended this seminar can use them to easily implement what they have learned from the course.

A complete understanding of the payroll law

Those who are responsible for payroll or employer tax withholding compliance or have just been hired or promoted into the payroll department would have discovered during their indoctrination just how important this role is to the success of the organization.

Their learning is a continuous process that goes on and on. Employees in this position need to build a solid foundation for handling their company’s payroll obligations and complying with federal and state payroll laws. They need to be familiar with how to find the authoritative laws to support their policies and procedures.

Clear and comprehensive learning

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will help participants achieve this. Miles Hutchinson, who is President, Sales Tax Advisors, Inc., and is a CGMA and experienced businessman, who brings over 35 years in the field, will be the Director of this seminar. To gain the benefit of learning from this expert, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900485SEMINAR.

Equipping participants with the law in all its depth

This organized and thoughtful learning session will help participants accelerate their learning and understand how to handle their role with confidence. Miles will help participants who are concerned about their company’s ability to comply with U.S. labor and payroll laws with a formal study of the rules of engagement. This will help ensure that their company pays their employees fairly and handles tax and other withholdings appropriately, as mandated by law.

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Miles will show where to find the laws, how to interpret them and how to apply them in the most effective ways. The objective of this learning is to equip its participants with the skill and knowledge needed to master the laws and identify the best practices to keep their organization in compliance and out of court. Implementing this saves them huge sums of money in fines and legal.

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A very broad range of topics will be covered at this seminar. These include:

  • Worker classification
  • Employee classification
  • Ways of establishing methods and rates of pay
  • What must be included in the rate of pay
  • Hours that must be compensated as worked time
  • Required benefits
  • De minimus working fringes
  • Withholdings and deductions from pay
  • Voluntary deductions
  • Child support and garnishment orders
  • Payroll reporting
  • Analysis of risks of noncompliance
  • Proper documentation of the policies and procedures and record retention requirements.

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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Identifying and managing key risks is the primary purpose of HR auditing

Human resources audit should qualify as the most important of all audits of an organization. This is because HR auditing is directly related to employees. This resource, the organization’s human capital, is the organization’s most important resource. It is through an HR audit that an organization evaluates this resource’s strengths and weaknesses.

HR audits help organizations in a number of ways

HR auditing helps organizations achieve this in many ways. Through HR audits, organizations are able to eliminate human capital risks, which will lead them to core actions such as ascertaining potential and actual problem areas, assessing the effectiveness of current HR management activities, measuring the weaknesses in HR internal control processes, evaluating human capital strategic and compliance related risks, and suggesting corrective action on all these.

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Getting the HR auditing right

Getting its HR audit right is the foundation to all these for an organization. The ways by which this can be achieved will be the subject of a two-day seminar that GlobalCompliancePanel, a renowned provider of professional trainings in the regulatory compliance areas, will be organizing. You can register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900675SEMINAR.

The Director at this seminar, Ronald Adler, who is President of Laurdan associates, Inc., will offer insights, accumulated over four decades in the industry, into HR auditing.

The basis of effective HR auditing lies in asking the right questions

Ronald Adler will emphasize the point that the root to carrying out HR audits effectively is in asking the right questions. The effectiveness of HR audits is measured by how they throw up a structured and systematic series of questions about the areas relating to key compliance, risk management, internal auditing, and human resource management issues in HR, which are the main purpose of these audits.

The role of ERM in HR audits

Another important point that Ronald Adler will highlight at this seminar is the importance of HR audits in considering human capital-related risks and opportunities from an Enterprise Risk Management (ERM) perspective. This means that the HR audit should take a holistic view of human capital risks and align the interrelationships and interactions between HR and other functions relating to management and the organization.

Yet another aspect that will be reviewed is the current use of HR audits. Adler will explain how HR Audits can be used to help the organization reduce risks and grab potential opportunities. All key personnel involved in human capital assessment, such as HR Professionals, CFO’s, Internal Auditors, External Auditors, Risk Managers, Compliance Officers, and COO’s, will benefit vastly from this seminar.

 

Get your HIPAA compliance right in six simple steps

The most important element that Covered Entities and Business Associates must keep in mind while carrying out HIPAA audits is best summarized in the words of Jocelyn Samuels, the top Federal official in charge of HIPAA enforcement. To quote her own words, Covered Entities and Business Associates must ensure compliance through “… a comprehensive and thorough approach to assessing and addressing the risks to all of the Protected Health Information (PHI) they maintain”.

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Although Risk Analysis is mandatory; HIPAA audits of 2012 showed that as many as four fifths of health care providers failed to comply with this mandatory requirement. Covered Entities and Business Associates are under severe pressure to do a HIPAA Risk Analysis of all the PHI’s they maintain. Most of this, they are expected to do on their own. This explains perhaps just why 80% of health care providers failed to do the Risk Analysis, a fact discovered by the HHS. In fact, the incidence of HIPAA violations has been increasing so steeply that 2015 was sardonically referred to in HIPAA circles as the “Year of the Breach”. This fact leads to the next important point: higher and greater number of government enforcement and private lawsuits.

Learn the ways of getting HIPAA compliance right in just six simple steps

The above facts make it absolutely imperative for Covered Entities and Business Associates to get every aspect of the HIPAA compliance right, in the manner suggested by Jocelyn Samuels. This is precisely what GlobalCompliancePanel, a highly renowned provider of professional trainings for all areas of regulatory compliance, will be imparting at a two-day, in person seminar. To enroll for his event, just visit

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900616SEMINAR?master-HIPAA-compliance-six-steps-San-Diego.

The Director of this highly meaningful and valuable seminar is the well-known expert on HIPAA compliance, Paul Hales. Paul’s credentials get augmented by the fact that he has, with a team of expert advisors and practical field testers, created a method of making all HIPAA regulations accessible to the everyday person. Paul’s method explains all the aspects of HIPAA in uncomplicated and simple language and carries the exact citations to each regulation. This method is directed at organizations’ legal counsel who may not be well versed or experienced in HIPAA, and will be a major part of this seminar.

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Major benefits by learning from the expert

Organizations that are required to carry out HIPAA audits will gain enormously from this seminar. It will help them to save money, time, and research. Paul will discuss how Business Associates and Covered Entities can grow their practice and be compliant. His method will serve as the very foundation on which organization can implement their HIPAA Compliance Program. Most importantly, he will teach how they can grow what is most valuable to their business: Their patients. Paul’s HIPAA compliance method, which consists of six easy steps, will create a level of quality to the advice that the legal counsel provides.

He will take participants of this seminar through a Risk Analysis for their organization and will also delve into the Privacy, Breach, and Security Rules as applicable to their particular organization.

Successful completion of Singapore Seminar by NetZealous on the topic “Why is FDA at my Facility, and what do I do During an Inspection” by David R. Dills

Fremont, CA, Jul , 19 2016: A highly interactive two-day seminar on the topic, “Why is FDA at my Facility, and what do I do During an Inspection”, was organized in Singapore by NetZealous, a leading Provider of Regulatory Compliance Trainings for a wide range of regulated industries on July 18th & 19th, 2016. The Speaker at this seminar was David Dills, Regulatory Affairs & Compliance Consultant.

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This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.

This presentation will review and emphasize the do’s and don’ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483’s and Warning Letters. Emphasis is placed on the company’s SOP on dealing with inspectors and knowing how to be prepared, proactive…and being able to defend and justify… and what it takes to achieve a favorable outcome.

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This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

More details about the seminar can be had from http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900547

About the Director:

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space.

He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.

About NetZealous:

NetZealous, a Fremont, CA-registered organization, DBA  GlobalCompliancePanel offers a broad range of high quality regulatory and compliance-related professional trainings and services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biological, drugs, food and biotechnology.

CEO of NetZealous, Satisha Naraharimurthy, has expressed his happiness and satisfaction that this seminar was held at a time when laboratories are seen to be struggling with their core issues relating to equipment qualification, calibration and computer system validation processes. He is satisfied that his organization served an important learning need for such professionals.

An understanding of what laboratory professionals need to do in order to meet regulatory requirements was what this seminar intended to impart, and it has done its job rather well, felt Shahanshah Manzoor, Co-Founder and Chief Marketing Officer at NetZealous.

The learning gained at this two-day seminar, which was packed with both substance and articulation, will go a long way in helping laboratory personnel at various levels understand ways by which to sort out the issues they have in relation to equipment qualification, calibration and computer system validation processes, believes Liju Mathew, Co-Founder and Chief Business Development Officer at NetZealous.

Contact information:

Call: 1-800-447-9407;

Visit: http://www.netzealous.com/