Training Courses, Classes, Seminars and Webinars

This seminar provides Professionals working in this area with A thorough understanding of the complexities involved All the relevant regulations and guidelines Real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901066SEMINAR?trainingregistry-September-2017-SEO

Inspire and influence your team members to achieve your goals as a team! Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation.. apply a consistent theory in leading your team.. and teach critical leadership skills to members of your team, so each and every one of them can lead the team in your absence. Why should you attend: Would you like to learn more about the differences between leading and managing? What about understanding how to more clearly visualize your goals and communicate them to your team? How about being able to better target your team's efforts? Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901082SEMINAR?trainingregistry-September-2017-SEO

Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product. The use of DOE methodology provides a means to identify process parameters which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes. Screening designs, such as 2k factorial and D-optimal designs, are used to determine critical process parameters. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901126SEMINAR?trainingregistry-September-2017-SEO

Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that you also have the proper policies and procedures in place. If audited or the subject of a compliance review, you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your small healthcare practice needs to understand how to put a HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive Two-day training course. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901024SEMINAR?trainingregistry-September-2017-SEO

There is no doubt that data integrity is the current and future inspection focus of all regulatory health care agencies. More than 50% inspection reports such as 483's and Warning Letters quote data integrity as deviations from GxP regulations. This new two-day course provides the regulatory background and guides attendees through the complete record lifecycle from data entry or acquisition through evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA's Part 11 and the EU/PICS Annex 11. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901060SEMINAR?trainingregistry-September-2017-SEO

An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901140SEMINAR?trainingregistry-September-2017-SEO

Understand Verification and Validation, differences and how they work together Develop a "Working Definition" of V&V, Qualification, and related terms Discuss recent regulatory expectations Software Verification & Validation requirements of the FDA and ISO. The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies Device and Manufacturing software requirements for V & V How to determine & demonstrate an appropriate V & V strategy Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900974SEMINAR?trainingregistry-September-2017-SEO

This two-day seminar will begin by laying the foundation for the subject by first defining what a project is and then discussing the unique roles that the project manager must assume along the length of any project. The Triple Constraint, the most fundamental of project management principles, will be explained in detail with examples and tools provided that can be used to integrate the principle into any project management process. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900996SEMINAR?trainingregistry-September-2017-SEO

Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901146SEMINAR?trainingregistry-September-2017-SEO

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle: Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901142SEMINAR?trainingregistry-September-2017-SEO

This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance. In this seminar, we will discuss: Regulatory Expectations How to plan, structure, and implement a quality system Common problems and lessons from 483 and warning letters Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901150SEMINAR?trainingregistry-September-2017-SEO

Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: Understand US FDA final rules for the Preventive Controls for Human and Animal Foods Define and review your current system to identify gaps in your preventive controls planning. Be able to develop and implement a valid preventive control company food safety plan to close any gaps Write and implement appropriate procedures. Know your requirements for control over your supply chain Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901120SEMINAR?trainingregistry-September-2017-SEO

Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. Many companies can spend significantly less time and money, and still be in control of their suppliers and in compliance with the regulations. This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation. The QSR/ISO requirements for supplier assessment will be defined as well. Attention will be paid to inclusion of risk management in across both supplier qualification and assessment, implementation of which will allow your company to devote value-added resources Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901002SEMINAR?trainingregistry-September-2017-SEO

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901124SEMINAR?trainingregistry-September-2017-SEO

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901170SEMINAR?trainingregistry-September-2017-SEO

On 25th May 2018 the EU-GDPR becomes effective, this date has been set to give organisations time to prepare and comply with the regulations. This may seem to be a long way off, but for most organisations there is a lot to be done. With the escalation of data breaches, the sooner data is safe guarded the better. Often a data breach is not discovered for months, sometimes six months, implementing new policies, security systems, negotiations with suppliers and training people in an organisation will take time. The sooner you start the more time you have to make a good decision on the options you face. This introductory course will give you an overview of the history of Data Protection within the EU and introduce you to the enhancements and new obligations imposed by the EU GDPR Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901168SEMINAR?trainingregistry-September-2017-SEO

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901122SEMINAR?trainingregistry-September-2017-SEO

Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars. Life supporting and life sustaining healthcare grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901104SEMINAR?trainingregistry-September-2017-SEO

Development of a safety program to save costs, delayed schedules and the human cost of injury or death. Safety management guidelines and techniques for the engineering, construction, and scientific professions. Includes costs of preparing the necessary safety documentation. It will emphasize using multiple techniques for each safety task. It will discuss costs of professional services from consultants. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901090SEMINAR?trainingregistry-September-2017-SEO

This seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits or (even worse) litigation occurs against your organization under state laws of negligence. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901046SEMINAR?trainingregistry-September-2017-SEO