Events
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The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic. How to Setup the Software. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar Start: 01/08/2012 10:00 am
Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company. High-profile field problems indicate that such activities are not yet adequately planned executed, and visibility maintained. There is a failure to fully utilize the power of current risk management tools. Effective use of such risk management tools can help address the growing push by the public and the FDA, to "toughen" its approach to product clearance and approval, while reducing liability issues. Why you should attend: The U.S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time. ISO 14971 and ICH Q9 provide accepted methodologies by which to perform and document such an analysis and is accepted by the FDA. These activities can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing. This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a “living document”. Areas Covered in the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 1000 N West Street | Suite 1200 | Wilmington | DE | Zip 19801 | USA Start: 01/08/2012 10:00 am
Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company. High-profile field problems indicate that such activities are not yet adequately planned executed, and visibility maintained. There is a failure to fully utilize the power of current risk management tools. Effective use of such risk management tools can help address the growing push by the public and the FDA, to "toughen" its approach to product clearance and approval, while reducing liability issues. Why you should attend: The U.S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time. ISO 14971 and ICH Q9 provide accepted methodologies by which to perform and document such an analysis and is accepted by the FDA. These activities can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing. This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a “living document”. Areas Covered in the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 1000 N West Street | Suite 1200 | Wilmington | DE | Zip 19801 | USA | 9
all day
The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic. How to Setup the Software. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar | 10
all day
The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic. How to Setup the Software. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar Start: 01/10/2012 10:00 am
Overview : Whether you are designing a new dress code policy, updating your current one or looking for suggestions how to implement your dress policy, this webinar should give you clear guidelines. Designing and implementing a dress code and dress policies for the workplace has become more complex today and should be addressed from many different angles: from creating a professional image to promoting a safe environment. Both the reasons and benefits for having a policy will be addressed as well as how to meet the needs of a diverse workforce. Before deciding on a formal dress code or updating your current one, many different approaches should be explored so that your decisions will promote a professional, safe and comfortable environment that reflects your culture in a positive manner. Why you should attend: It will cover your reasons and rights as an employer to establish and enforce a dress code and how to develop and adopt one that complements your business. Considerations range from what is considered professional attire to cultural and generational preferences. We will discuss how to establish clear guidelines for employees, the reasons behind decisions for dress and how to effectively and legally implement an effective and fair policy. Areas Covered In the Session: Reasons to have a Dress Code Who will benefit: Chief Human Resource Officers Start: 01/10/2012 10:00 am
The webinar focuses on effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as those of the regulators and thereby significantly reduces your companies exposure to audit failures. Risk management activities involve processes, methods, and tools for identifying, assessing and managing risks. These activities are conducted in a disciplined environment. It requires proactive decisions to continuously assess what could go wrong during the manufacturing of any product. This webinar addresses how to identify the critical risks and mitigate them. It provides a systemic prospective of QRM using the Swiss cheese model. Specifically, it focuses on key factors for a successful Risk Management process, the 7 key concepts in FDA's systems approach thinking to Risk Management, the required QRM documents and their contents and Risk Assessment methods and tools. The webinar aims to equip and empower attendees with the knowledge of basic risk management terminology, the deployment of appropriate tools for risk assessment, FDA's audit care about for QRM , as well as how to apply risk management principles to various aspects of a quality system. Among the topics to be discussed are the key steps in the identification of risks, establishing a scoring criteria to analyze identified risks, use of the 5-p model for risk reduction, risk acceptance basics including factors that establish a risk acceptability criteria, elements of a Risk Control strategy and what and when to communicate with risk stakeholders. Since Risk Management is a dynamic process, topics will also include how to continuously monitor risks and integrate them into a continual improvement strategy, along with the management's role of ensuring the adherence to the strategy. Why you should attend: ICH Q8, Q9 and Q10 have been the bedrock of the regulatory agencies' regulations for pharmaceutical cGMPs for the 21st century. While adoption of these has been slow, some like Q9 and Q10 are increasingly coming into acceptance by the industry. Adoption of concepts such as Q8's QbD have been slow because it is still in its infancy and will require more time if it is to have the transformative effect first conceived by ICH. However, QRM (Q9) and Quality Systems (Q10) are increasingly coming into acceptance by the industry since their understanding is not as intricate and complex as QbD is. It is becoming increasingly evident that application of QRM (Q9) techniques would provide the refinement tools to formulate and validate the QbD (Q8) models of the processes. Hence a good understanding and application of QRM techniques and tools would be instrumental in the development of realistic QbD models that are more reflective of true process characterization and actual process behavior. The approach to quality and risk management is dynamic in nature due to the evolution of science and technology. This dynamic nature imposes a challenging situation for companies since they are now required to keep themselves fully trained and informed of the changing regulations. Additionally, with the increasing formalization of QRM tools and techniques, regulatory agencies are requiring companies to establish Quality Risk Management Plans that are being used as starting points for their audits. The requirement for performing QRM coupled with QRM's dynamic nature increases companies' risk of audit failures. Citations arising from such audit failures are being addressed through a consistent documentable approach to risk management throughout the company irrespective of the business and manufacturing processes. This webinar addresses the "common language of risk" coupled with the documentation strategy required to maintain a defensible risk control strategy to meet compliance requirements. Areas Covered in the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 Start: 01/10/2012 10:00 am
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs. Areas Covered in the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 Start: 01/10/2012 11:00 am
During this webinar we will examine the DSM-IV diagnostic symptoms of Childhood Bipolar Disorder and review innovative research. Executive deficits and behavioral changes signaling the onset of the disorder will also be discussed. Full Description: During this one-hour webinar, we will outline the DSM-IV diagnostic symptoms of bipolar disorder and review innovative research on bipolar disorder contrasted with a new DSM-IV diagnosis. Research on the sequelae of bipolar disorder, including executive deficits, will be described as well as the prodromal conditions and behavioral changes that signal the onset of childhood bipolar disorder. A probability nomogram, a novel decision tool which improves the interpretation of family history and test data by diagnosing clinicians, will be presented and discussed. Strategies by Dr. Miklowitz will be offered to support clinical and educational treatment options. Course Includes: What You Will Learn: Your Presenter: Disclaimer: Technical requirements: Who Should Attend: | 11
all day
The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic. How to Setup the Software. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar Start: 01/11/2012 10:00 am
Why you should attend: Price List: webinars@mentorhealth.com Phone: 800-447-9407 Start: 01/11/2012 10:00 am
This webinar will examine the FDA's recently instituted annual "Strategic Priorities" initiative, with emphasis on 2012. Such a review will focus on the broad range of issues a company's senior management and QA/RA need to consider in their annual Management Review of their existing quality management system. This review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what the FDA and industry need to do internally. An additional review of recent information from the Agency, other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of applicable FDA "Strategic Priorities" areas for required review or related industry problem areas. The result will be a basis for such a management review and a listing of likely milestones and tasks. Anticipation and addressing of weak spots proactively will further prove a company is "in control", assist in timely review of submissions to the Agency, and in any remediation efforts. Why you should attend: Each year companies are to perform a complete review of their quality management system and its ability to meet the current GMP's. The FDA has added a "Strategic Priorities" initiative that can assist companies to proactively address areas of GMP concern. There is a major shift in the emphasis of the U.S. FDA cGMP compliance audits, clinical trial expectations, product submissions and company response requirements. In short, all regulatory areas are under evaluation by the FDA, and need to be revisited by a company's QA/RA and its senior management. There is "no business as usual". This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. Recent negative publicity on pharmaceuticals, devices, as well as events in unrelated industries have put pressure on the Agency to "get tough on compliance / enforcement". This webinar will trigger such a response by an examination / review of FDA's "must-have" for corporate CGMP compliance. Areas Covered in the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 Start: 01/11/2012 10:00 am
This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle. Optimized lyophilization cycle design can be an extremely difficult and daunting task for the scientist that is unskilled or under skilled in the process. This is becoming even more prevalent as many of the molecules coming out of discovery are more complex, unstable, and require a very specific, multi component formulation to impart not only good chemical stability and physical stability to the active ingredient, but also good physical stability to the dried solids themselves. Unfortunately, many of the molecules that are used to help stabilize the chemical and physical stability of the active ingredient, impart poor physical stability to the dried solids and can make lyophilization cycle design difficult. The development scientist who understands and can apply these principles, will be much better equipped to develop robust cycles that can be used to produce quality products consistently, in the shortest amount of time possible, saving time and money. This webinar will start out with an introduction to thermal characterization including differential scanning calorimetry (DSC) and freeze-dry microscopy (FDM) and how the information gained from these techniques can be used as the foundation for optimized cycle design. Next, the webinar will discuss, in detail, the process of designing the freezing, primary, annealing (if used), and secondary drying protocols for the cycle. In each case, the process will be broken down to understand the correct choice of the different controllable lyopohilizer parameters including shelf temperature, chamber pressure, and hold times. Also discussed, will be some of the specialized tools that can be used to aid the development scientist in cycle development including, the sample thief, the Pirani gauge, and thermocouples. Areas Covered in the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 Start: 01/11/2012 10:00 am
The topic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for sustainable, root cause solutions, we must also turn our attention to supply chain integrity and deal with both security and integrity concurrently. An Oxford on-line dictionary definition of integrity is "the state of being whole and undivided". Over the last 40 years, the Pharma supply chain has fragmented to the point where it is a million miles from that state. There are now multiple business models, such as virtual, biotech, specialty Pharma, innovator, generics, biosimilars, etc and a divergence of supporting actors, such a contract manufacturing organizations (CMOs), contract research organizations (CROs), central laboratories, third party logistics providers, pre-wholesalers, wholesalers, specialty pharmaceutical providers (SPPs) etc. As a result, our supply chains have dis-integrated to the point where visibility and accountability have become blurred at the edges - and it is this disintegration that has opened the doors to criminal activity and errors in quality outcomes. The solution is not an easy one. It requires urgent action to mitigate activities of the 'bad guys', together with a longer term approach to ensure the 'good guys' get better at building and managing robust supply chains. This can only be achieved by collaboration between regulators, other enforcement agencies, technology providers and the industry itself. Where do we start? We must initially focus on the end-to-end supply chain in its current state. Chains of custody and ownership must be clearly identified and remediation actions agreed by responsible parties to plug the gaps that currently exist. For example, Quality and technical agreements must become far more 'process' orientated so that they become working documents shared between business partners, rather than merely a static list of tick boxes. Change control has to work on upstream and downstream impacts that might affect supply chain integrity and procurement must forge supply agreements that impose obligations for supply chain visibility on prospective partners. This and much more needs to happen and will be discussed in the session. Then we must turn attention to the building of supply chains for the future - the product development phase. This industry is unique in that the entire supply chain must be registered with competent authorities before approval to sell and post-launch changes have to be approved. This places a great responsibility on getting it right from the start. This is where the opportunity lay for sustainable improvements in the physical architecture of the supply chain and the underpinning management processes and information flows. A foundation for this has already been put in place by the regulators through FDA's 21st Century Modernization initiative and ICH Q8 - 11 guidelines. The key to translating these initiatives into meaningful supply chain improvements, however, it in understanding the patient value proposition and the organizational/cultural elements that must firstly be in place, and these are explored in some depth. Why should you attend: The Pharmaceutical supply chain has never been in such turmoil and under such attack from governments and regulators globally. The evidence is stark and mounting. Supply chain shortages in the US have moved even the President to demand urgent remediation; high level congressional committees have also asked searching questions of FDA and other involved stakeholders, in an attempt to discover what has been going on with high profile supply chain failures. Cargo theft, diversion and counterfeiting have become almost endemic, with detection and enforcement efforts stretched to the limit. Finally, and possibly most worrying of all, are the cases where materials have been adulterated or substituted with toxic alternatives (for economic gain) and have progressed undetected through one or more stages in the supply chain causing eventual patient death. Areas Covered in the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 | 12
all day
The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic. How to Setup the Software. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar Start: 01/12/2012 9:00 am
Many top executives often feel isolated from their teams, other leaders, and even their families. They miss the hands-on mentoring and coaching they received on their way to becoming an executive. More and more top leaders are turning to an Executive Coach to help with their performance and development. What is an Executive Coach? How does the process work? What tools do they use? Executive Coach and Price Associates expert Whit Mitchell gives leaders an inside perspective on Executive Coaching. From personal development to interpersonal skills to performance coaching, Whit will discuss how Executive Coaching can fill the void top leaders often feel. This open, transparent webinar gives you insights on how Executive Coaches are becoming a key business and personal resource for effective executives. Date: Thursday, January 12, 2012 What you will learn: If you are a leader or a future leader, this is a must-attend event for you! Statistics in Quality Control - Critical decisions-Risks & Basics - Webinar By GlobalCompliancePanel
Start: 01/12/2012 10:00 am
Statistical Applications includes topics related to basic statistical applications and advanced statistical applications such as statistical process controls (SPC). Includes elements of central tendency, dispersion, proportions and percentages, probability, capability, control limits, specifications limits and more. Why you should attend: To learn of many different areas of basic and statistical process controls applications such as central tendency, dispersion, proportions and percentages, graphical and normal distributions, control limits, specification limits, process capability and more. Areas Covered in the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 Start: 01/12/2012 10:00 am
End: 01/12/2012 11:00 am
Why should you Attend: FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. They are certain to impact your regulatory risk profile. How will you prepare for software quality, software validation and 21 CFR part 11 planning? Extensive use of automated manufacturing, laboratory, QA, QC, complaints, CAPA, Adverse Events systems puts companies at risk. FDA field staff has been trained on software validation and 21 CFR Part 11 inspection and enforcement. Many companies have fallen behind in their software validation practices. Now is the time for forward planning in this crucial area. This executive planning session discusses the key elements on which to focus. The attendee should leave this strategic planning session confident in knowing how FDA will approach software validation enforcement and how to prevent needless inspections, as well as how to satisfy an FDA inspector. Areas Covered in the seminar:
Start: 01/12/2012 10:00 am
There is a need to implement an adequate formal level of change control during engineering projects (referred to as an Engineering Change Control) after the approval of the equipment/systems specifications in addition to the more formal change control after the qualification of these systems. The Engineering change control process will apply through design, construction and qualification up to the point that the system is considered installed/operational. The new Quality Systems guideline from the FDA states that the Quality function must be involved in the review of the design and subsequent changes to the design of facilities, equipment and systems that may impact the product quality. The question is - how much involvement is really necessary from all functional groups including the Quality group? The course will include instructions on how to: Areas Covered In the Session: Price List: webinars@globalcompliancepanel.com Phone: 800-447-9407 Start: 01/12/2012 12:00 pm
Short Description: Full Description: This webinar will review the current research and discuss specific ways of screening for Developmental Prosopagnosia in children with and without ASD. Empirically proven treatment methods will be discussed and specific techniques of accommodating children will be outlined. Course Includes: What You Will Learn: Your Presenter: Dr. Blake serves as a member of the American Psychological Association, International Dyslexia Association, Children and Adults with Attention Deficit Disorders, Learning Disabilities Association, and the National Attention Deficit Disorder Association and was a 1991 delegate to the National Institute for Literacy’s “LEAD 2000 Congress,” where he advised Congress on diagnostic and remediation issues. Disclaimer: Technical requirements: Who Should Attend: Start: 01/12/2012 2:00 pm
During this webinar we will discuss evidence-based treatment and medications used to modify the symptoms of ADHD, Obsessive-Compulsive Disorder, and Tics. Similarity of symptoms, frequency, and their debilitating nature will also be identified. Full Description: The Triad describes a set of three disorders that have similar neuropsychological sources: ADHD, Obsessive-Compulsive Disorder, and Tics. The symptoms of these disorders possess frequency, drive, and intensity beyond the norm. The symptoms can be chronic and debilitating, interfering with social, cognitive, and emotional development. We will discuss how symptoms can be modified and improved with evidence-based treatment. Medication to treat ADHD will also be reviewed. Course Includes: What You Will Learn: Your Presenter: including Child Study Journal, Language and Speech and Journal of Child Psychology. Her papers have been presented to the American Educational Research Association, American Psychological Association and the Society for Research in Child Development. Dr. Remig's national seminars include "The Human Brain and Learning Styles," "The Human Brain and Motivation," "ADHD and the Brain," "Learning Disabilities and ADHD: Behavioral Interventions" and "Pervasive Developmental Disorder: Autism, Rett's, CDD and Asperger's Disorder." Dr. Remig is a member of the American Psychological Association and an instructor for the University of New Hampshire. She is a Fellow of the Prescribing Psychologist Register (F.P.P.R.) and a Fellow in Serious Mental Illness (F.S.M.I.) from the Prescribing Psychologist Register. Both fellowships are awarded by the International College of Prescribing Psychologists. Dr. Remig also passed the ICCP National Examination for Psychologists in Psychopharmacology. Disclaimer: 15 to 20 minutes early. Speaker phone sound quality is poor and it is recommended that they not be used to listen to the event. Technical requirements: https://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php Who Should Attend: Officers), Occupational Therapists, Certified Occupational Therapy Assistants, Parents | 13
all day
The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic. How to Setup the Software. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar Start: 01/13/2012 10:00 am
End: 01/13/2012 11:00 am
Don't Be Caught in the 20th Century Rut… During This Webinar You Will Learn How To: All Registrants Will Receive: About the Presenter: | 14
all day
The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic. How to Setup the Software. The Webinar will held on request, the duration is approx. 30 Minutes Further Information to the Online-Seminar |
