GlobalCompliancePanel

The Job of the Corporate Controller in Today's Environment at SFO

Overview: Prepare yourself to take on the role of the Corporate Controller. Your career path offers you the opportunity to step into this position, but it comes with risks. Do you really know what it takes to move up to this highly visible leadership role? Invest in your future and join us to learn exactly what it takes to successfully transition into this key position. Identify the necessary core competencies of the role and become more self-assured as you work to properly define this role for you and your company. This is a practical seminar designed for financial professionals on the...

ISO/IEC 17025-2005 and Laboratory Accreditation at Boston

225 William F McClellan Hwy, Boston, MA 02128, USA

Overview: QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. The Quality System Manual (QSM) is the bible in a QMS environment because, much like its predecessor, Good Laboratory Practice (GLP), it contains the policies that the laboratory is expected to follow to achieve quality results. It is in fact only the "what to do" component of a QMS. What is also needed are the "how to do it" or procedures and methods and finally the controls or evidence that it was done properly. Why should you attend? Many laboratories struggle with developing and...

Promotion of Biomedical Products: Regulatory Considerations at Los Angeles

120 S Los Angeles St, Los Angeles, CA 90012, USA

Overview: This course provides a basic overview of the laws and regulations affecting the advertising and promotion of drugs, biologics, and medical devices. It is specifically designed to clearly illustrate how the law and regulations are applied on an everyday basis without having to read through volumes of "legal-ese" text. Why you should attend: This course provides a basic overview of the laws and regulations affecting the advertising and promotion of drugs, biologics, and medical devices. It is specifically designed to clearly illustrate how the law and regulations are applied on an...

Software Risk Analysis Tools for Medical Devices and Risk Mitigation at Chicago

2950 S River Rd, Des Plaines, IL 60018, USA

Overview: The FDA recalls related to software performance are on the increase for at least five years at the time of this writing. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA. Similar to hardware, software also has hazards (any source of harm) and hazardous situations which transform a hazard into harm. We must identify hazards and identify what event can turn them into harm and write software specifications to prevent such combinations. The risk management tools such as FMEA (Failure Mode and Effects Analysis), FTA...

International Trade: Strategies to Enhance Financing and Operational Success at Los Angeles

120 S Los Angeles St, Los Angeles, CA 90012, USA

Overview: Upon completing this course participants should: ·         Understand how to identify international trade opportunities; when you see lead from the Commerce Dept. validate it with due diligence by asking hard questions to validate the leads. ·         Utilize International trade to build revenues through sales and profit maximization. ·         Evaluate effectiveness, suitability and adaptability of implemented solutions/corrective actions by implementing project management and/or CRM solutions ·         Receive a tool box of methods to...

Construction - Construction Hazards & Basics, for any Jobsite at SFO

Overview: Real world examples of what to expect, and what to prepare for whenever possible. Not every organization is ready to avoid inspections or fines if they do not have senior staff in place, and/or if they have not been audited in the past. How to train staff to have the correct documentation in place. Ensure that the organization keeps documentation updated and realistic. If an employee is nervous and informs the inspector/auditor wrong information, a strong documentation system will support all of the proper steps that are in place. What to strive for and whom to ask for help and...

Seminar on Personal Work Retreat - Refresh, Refocus, and Reactivate at SFO

Overview: With all of the deadlines, projects, and tasks that you have to do every day at work, it's hard to find time to set personal development goals that positively impact your work performance and help you to grow professionally. But how will you advance in your career if you don't make time for values clarification, goal setting, and increasing productivity? Without a concrete plan in place, you are at risk of stagnating in your current position and experiencing burnout. Taking a personal retreat is an effective and time-efficient strategy for moving your career forward and recharging...

The Statistics of- Design Verification, Process Validation, and Statistical Process Control at SFO

Overview: This 2-day seminar provides a 1-day introduction to the statistical tools used to analyze Design Verification data and Process Validation results. The 2nd day is spent on Statistical Process Control and Process Capability Indices. The goal of the 1st day is to help the student understand how to choose statistical methods and sample sizes, and to correctly interpret the results. The goal of the 2nd say is to explain how to monitor a validated production process, using tools that will also help improve the product. Why should you attend? All design and/or manufacturing companies...

Seminar on How to Conduct Medical Device Risk Analysis Effectively at SFO, CA

Overview: Why companies are prone to having past problems in new devices? One of the main reasons seems to be the �weak cognition.� It is usually the result of short term memory, inattention to details, insufficient vigilance, or multitasking. This unsafe work propagates unknowingly because of not engaged or disengaged employees, insufficient understanding of customer needs, splitting design among several designers, and ineffective risk analysis. Another big reason is that ineffective device management procedures often touted as 'best practices', are like a bad virus with long incubation...

Design of Experiments (DOE) for Process Development and Validation at Singapore

Overview: 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 that critical quality...

Applied Statistics for QA, QC, Manufacturing, and Design Control at SFO, CA

Overview: The 2-day seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics. Basic vocabulary and concepts are then reviewed and discussed. The flow of subsequent topics over the 2 days is as follows: How to calculate confidence intervals (for proportions and for measurements), including a discussion of how to choose sample size How to perform an interpret t-Tests, including consideration of "significance", "p-values", "power" and sample-size considerations How to perform calculation of confidence/reliability for attribute data How...

Seminar on Applied Statistics for Scientists and Engineers at Zurich, Switzerland

Zurich, Switzerland

Overview 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...

Tougher Import Rules for FDA Imports in 2015 at San Diego, CA

1646 Front St, San Diego, CA 92101, USA

Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. A number of factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the...

Problem Solving and Root Cause Analysis - the Key to an Effective CAPA System at San Diego, CA

1646 Front St, San Diego, CA 92101, USA

Overview: This program is designed to provide participants with: ·         Understanding and developing an effective Corrective and Preventive Action System ·         An understanding of a structured problem solving process ·         Tools and techniques to perform root causes analyses ·         The use of facts and data to eliminate the use and identification of ineffective solutions. An 8-Step Process is presented during the program, consisting of: 1.     Identify the Problem 2.     Identify the Team 3.     Contain the...

Why You Should be worried about HIPAA at Washington, DC

140 L Street Southeast, Washington, DC 20003, USA

Overview: We will be discussing the history and evolution of HIPAA Privacy/Security and the major points you need to understand to proactively protect your practice or business. Specific areas covered will be: ·         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...

Statistical Techniques for Medical Device Manufacturers at Philadelphia, PA

Overview: The FDA's Quality System Regulation (QSR) requires device manufacturers to identify valid statistical techniques to "establish, control, and verify the acceptability of process capability and product characteristics." When device manufacturers analyze CA&PA; information, they must also use "appropriate statistical methodology". Some manufacturers are not clear about all of this. Others are nervous that their approach is sufficient. In addition, sampling plans must be valid, documented, adequate, and reviewed based on changes. These issues can create a patchwork of techniques...

Promotion of Biomedical Products: Regulatory Considerations at Baltimore, MD

Baltimore, MD, USA

Overview: This course provides a basic overview of the laws and regulations affecting the advertising and promotion of drugs, biologics, and medical devices. It is specifically designed to clearly illustrate how the law and regulations are applied on an everyday basis without having to read through volumes of "legal-ese" text. Why you should attend: This course provides a basic overview of the laws and regulations affecting the advertising and promotion of drugs, biologics, and medical devices. It is specifically designed to clearly illustrate how the law and regulations are applied on an...

Seminar on International Trade - Strategies to Enhance Financing and Operational Success

Boston, MA, USA

Overview: Upon completing this course participants should: ·         Understand how to identify international trade opportunities; when you see lead from the Commerce Dept. validate it with due diligence by asking hard questions to validate the leads. ·         Utilize International trade to build revenues through sales and profit maximization. ·         Evaluate effectiveness, suitability and adaptability of implemented solutions/corrective actions by implementing project management and/or CRM solutions ·         Receive a tool box of methods to...

Design of Experiments (DOE) for Process Development and Validation at Seattle, WA

Seattle, WA, USA

Overview: 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 that critical quality...

2-day In-person Seminar on Why You Should be worried about HIPAA at SFO, CA

San Francisco, CA 94128, United States

Overview: We will be discussing the history and evolution of HIPAA Privacy/Security and the major points you need to understand to proactively protect your practice or business. Specific areas covered will be: ·         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...

Seminar on Medical Device Software Development at Boston, MA

Boston, MA, USA

Overview: This seminar is mainly based on the IEC62304:2006 standard and will introduce the main elements and requirements for the development of modern software systems for medical devices. Emphasis is placed on understanding the underlying principles that generate the requirements of the standard, to understand strengths, the shortcomings and weak parts of the standard and give practical, proven guidance on how to implement the requirements necessary for regulatory approval. This seminar goes beyond teaching the mere content of the standard, but will provide the toolset to understand the...

Clinical Trials and Clinical Product Development in the EU: Regulatory Affairs Aspects

Zurich, Switzerland

Overview: The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider. The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development. Orphan medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained. Scientific advice is a vital element in the development of a medicinal product, and knowledge of the how to choose between...

2-day In-person Seminar on Submitting Marketing Applications in Canada at Seattle, Washington

16038 W Valley Hwy, Tukwila, WA 98188, USA

Overview: Topics included will include the filing of New Drug Submissions for various types of pharmaceutical companies, priority submissions, organization of Health Canada, process for approval of applications, timeframes and cost for approval. We will cover the review of New Drugs and Old Drugs. Also included will be Natural Health Products. Canada has pricing controls, unlike the US. Reimbursement in Canada is very much related to the healthcare system in Canada. An overview of reimbursement will be covered. Why should you attend? Understanding the process in Canada for the registration...

2-day In-person Seminar on Using Statistical Methods for ICH Guidelines at Barcelona, Spain

Avinguda Diagonal, 589, 08014 Barcelona, Barcelona, Spain

Overview: This hands-on course will provide attendees with an understanding of how to apply statistical methods to the ICH Q series guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.  This 2 day hands-on workshop explores the unique challenges facing all facts of a pharmaceutical or biotechnology company. Practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies....

Seminar on Quality Assurance for Microbiological Laboratories at Chicago

2950 S River Rd, Des Plaines, IL 60018, USA

Overview: QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. The Quality System Manual (QSM) is the bible in a QMS environment because, much like its predecessor, Good Laboratory Practice (GLP), it contains the policies that the laboratory is expected to follow to achieve quality results. It is in fact only the "what to do" component of a QMS. What is also needed are the "how to do it" or procedures and methods and finally the controls or evidence that it was done properly.  Why should you attend? By the end of this 2-day interactive workshop,...

2-day In-person Seminar on Extracting Information from Geochemical Data at Salt Lake City, UT

Overview: Most specialists strongly recommend to sample every meter of the drill core or of a trench and to use multi element analysis, rather than just asking the laboratory for gold test. There are also many other types of analysis that are ignored by the industry. But even when such analyses are requested, most of the time the fed geologist is not well trained on the necessary techniques and methods to extract all the information contained in the data. This seminar will teach you what to ask and how to extract all the important information of your data Why should you attend? You, as a...

Human Subjects Research Seminar: Current Regulations under FDA and HIPAA at San Diego, CA

1646 Front St, San Diego, CA 92101, USA

Overview: This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. We will discuss a variety of research including genetic, drug, device, and studies that use off-site or community...