Pharmacy Training and Seminars

Medical

Pharmacy Training Classes Considering a career as a Pharmacy Technician
Some important terms: healthcare, medical, pharmacist, pharmacuticals, pharmacy, pharmacy technician administration, coding, doctor, medical, nurse and physician.
Pharmacy Training Seminars and Classes
From Online Training Directory
Pharmacy Technician Career Training Program on-line e-learning cbt (computer based)study at homecourseware ... student with no prior experience, into a new career as a Pharmacy Technician. Unlike many other career opportunities that come and go, medical careers are here to stay! Because of the widespread use of medication, Pharmacy Technicians have never been more in demand and the field will continue to grow in the years to come. As a Pharmacy Technician, you will assist the Pharmacist with direct  more...
Pharmacy Technician National Certification Exam Preparation Course on-line e-learning cbt (computer based)study at homecourseware ...Pharmacy Technician (CPhT)? Take your career to the next level and get this credential. Many Pharmacy Technicians who become certified receive financial compensation and several states are even requiring Certification for employment. Keep your employment opportunities open and make the most of your career by becoming Certified. The Pharmacy Technician Certification Board National Exam is a  more...
From NobleProg - IT training courses
Drug Design instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewareworkshop / seminarcomputer lab This course has been created for people who want to understand the basics of structural bioinformatics including protein-ligand docking and virtual screening, i. e.: Researchers whose main area or expertise is not a structural bioinformatics, but they want to broaden their knowledge in this field Computer programmers who are going to deal with structural data (crystal structures, PDB format  more...
From Technology Ed
Pharmaceutical Fundamentals Certificate Program on-line e-learning cbt (computer based)study at homeself directed Program Description The pharmaceutical and medicine manufacturing industry develops and produces a variety of medicinal and other health-related products that save the lives of millions of people from various diseases and permits many people suffering from illness to recover to lead productive lives. This industry is dependent on discovering and developing medicines, manufacturing these  more...
Pharmaceutical Manufacturing An Introduction Course Description This course provides an overview of the pharmaceutical industry, including basic information about drug discovery and development, FDA requirements and approval processes, drug dosage forms, and the role of key operational units in drug manufacturing processes. This course enables the students to: understand the role of the pharmaceutical industry in the global market and its  more...
Pharmaceutical Validation Processes on-line e-learning cbt (computer based)self directed Course Description This course provides a basic understanding of the validation process as required by the Food and Drug Administration of the United States for drugs manufactured in the United States and all imported drugs. This course also reviews applicable definitions and descriptions of the process and documents required in the validation of a facility. The process of validation is  more...
Pharmaceutical QA Regulatory Affairs on-line e-learning cbt (computer based)study at homeself directed Course Description Quality assurance and control measures are mandated both by the development company and by regulatory agencies to ensure product identity, purity and safety. This course presents the regulations set forth by regulatory agencies with emphasis on the FDA model. We also introduce Good Manufacturing Practice criteria and reviews Quality Assurance and Quality Control functional  more...
From Clinical Research Training Centre
Monitoring Upgrade for GCP Certificate Holders on-line e-learning cbt (computer based)study at homeself directedworkshop / seminarcomputer lab Qualifying program, allowing university graduates with GCP certificates to get additional training and practical hands-on experience on clinical trials monitoring and become eligible to work also for CROs and pharmaceutical companies as Clinical Research Associates (Monitors)in industry sponsored clinical trials. Includes extended theoretical and practical course on the N. American regulations,  more...
From ComplyStream
Creating Clinical Plans for Medical Devices instructor led trainingon-line e-learning cbt (computer based)group study and discussionself directedcd romDVD A correctly designed clinical trial not only can allow for marketing approval by FDA and other regulatory agencies, but also provide the data necessary to demonstrate a clinical utilitya and capture market share. Too often firms fail to recognize the need not to just accomplish clinical endpoints that demonstrate safety and efficacy, but to establish clinical endpoints with clinical  more...
South East Asia Regulatory Compliance for Life Science Products - Hong Kong Taiwan Thailand Singapore Malaysia and Vietnam instructor led trainingon-line e-learning cbt (computer based)cd romDVD This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in listed South East Asian Countries. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies. Content will also include descriptions of the  more...
From GlobalCompliancePanel
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration - Webinar by GlobalC All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. NetZealous LLC, DBA GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Determining the Necessary Laboratory Water Specifications and Simplifying Water System Validation - Webinar by GlobalComplianceP This webinar will assist the attendees in logically investigating and defining the specific quality attributes their lab water systems need and not just default to manufacturing's required water quality. NetZealous LLC, DBA GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Ensuring Integrity and Security of Electronic Records for FDA Compliance - Webinar By GlobalCompliancePanel FDA has found and reported about multiple cases where companies manipulated electronic records to bring out-of-specification results into specifications. Since then FDA inspectors have focused during GLP, GCP and GMP inspections on security, availability, accuracy and integrity of 'complete' records. FDA has trained inspectors to identify data falsification and recommended the same to industry  more...
The DHF DMR DHR and the Technical File-Design Dossier -USFDA and EU MDD Requirements - Webinar By GlobalCompliancePanel This webinar will examine the existing and proposed requirements for the U. S. FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/ DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed. Also considered: Areas  more...
Implementing Medical Device Complaint Handling Systems - Webinar By GlobalCompliancePanel This webinar is intended to demonstrate how to implement medical device complaint handling systems. All medical device manufacturers are required to comply with the complaint handling requirements. Understanding the relevant and applicable requirement can significantly contribute to achieving compliance and remaining compliant, resulting in saving significant amount of time and efforts in  more...
Lyophilization Process Development and Cycle Design with a Case Study -Webinar By GlobalCompliancePanel 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  more...
Statistical Procedures Needed for Compliance with the Guidance on Process Validation -Webinar By GlobalCompliancePanel This guidance document contains several statements that make it clear that statistical procedures will be expected. Recently, FDA issued new draft guidance on process validation. When finalized, it will supersede the previously issued guidance documents on process validation. It is expected that the final guidance will not be much different from the draft. This guidance document contains  more...
Configuration Management and Change Control for Computer Systems - Webinar By GlobalCompliancePanel It is well known that most problems of software, computer systems and networks are introduced when changes are made, either during design and development or during use of the systems. Too many changes of computer systems and inadequate documentation of changes and testing after changes is one of the most frequently cited deviations during FDA inspections. Users of the systems, system owners  more...
Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar By G What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product? These topics and more will be addressed during this Webinar,  more...
Process Validation Principles and Protocols for Medical Devices - Webinar By GlobalCompliancePanel This webinar explains the regulatory requirements for process validation, and also includes definitions and application of applicable terminology, and hints and recommendation for the more common types of process validation. Also covered will be the validation technique used for processes that are already in place. NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216,  more...
Understanding Analytical Test Results Comparing Two Sets of Data - Webinar by GlobalCompliancePanel The discussion will cover the misconceptions and present methods to allow proper comparisons, while considering the risks inherent in decisions based on analytical data. NetZealous LLC, DBA GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Using Statistics to Determine Sample Size - Webinar by GlobalCompliancePanel This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
FDA Guidance Regarding Clinical Trials for Foods Food Ingredients and Dietary Supplementsn - Webinar By GlobalCompliancePanel The FTC, along with the FDA, work together to ensure manufacturers and distributors are up to date with the requirements for product labeling and acceptable marketing claims. These two organizations will continue to get more involved in dietary supplement regulation and it is important for manufacturers to comply with the current recommendations. This webinar will review the dietary supplement  more...
What is the HIPAA Compliance HIPAA Privacy Compliance Training 2018 This two-day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is.  more...
Medical Device Software Risk Management Standard Software Expert 2018 Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software  more...
A Risk Based Approach to Testing of Computerized GxP Systems 2017 Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e. g. EU GMP Annex 11.  more...
GMP and Regulatory Expectations for Early IND Products This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion  more...
Medical Device Software An Incremental Approach to Risk and Quality Management 2017 Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage  more...
Onsite GCP Review and Update including the all-important Investigators Responsibility 2017 This seminar is designed to acquaint all Participants with the Rules and Regulations that form the background of what is know as the GCP of Clinical Research. To follow "The Good Clinical Practices" (GCP) is to follow the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trails that provides assurance that the data and reported  more...
The EU Clinical Trial Regulation EU Filings Registrations 2017 This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU  more...
Validation Verification and Transfer of Analytical Methods from FDAEMA USP and ICH 2017 Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative  more...
Medical Device Single Audit Program MDSAP Implementation Participating Country Regulatory Processes 2017 Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies  more...
Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017 Japan's classification system differs from that of the United States or European Union Medical devices are classified to Class I, II, III, or IV depending on their risk level Medical devices must also comply with Japanese Industrial Standards and these standards define industry-wide safety and performance requirements Strict new package insert requirements  more...
HR Auditing Identifying and Managing Key Risks 2017 HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance, risk management, internal auditing, and human resource management issues  more...
Design Controls for Medical Devices - Regulations Myths Challenges and Best Practices 2017 Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. This 2 days seminar will help you understand and develop design controls processes and tools that are a competitive strength for your company.  more...
FDAs Latest Regulations for Computer Systems Used in the Tobacco 2017 The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA s authority to include the regulation of electronic nicotine delivery  more...
Effective Internal and External Quality Assurance Auditing for FDA Regulated Industry Principles and Audit Planning Planning and preparation Internal audits are critical element of your quality management system. Your approach must be both systematic and documented to remain compliant Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes Audit types and  more...
Data Integrity FDAEU Requirements and Implementation 2017 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.  more...
Writing and implementing effective SOP 2017 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  more...
Validation of Computer Systems for Quality and Software Embedded Medical Devices 2017 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  more...
Why you Should be Worried about HIPAA 2017 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,  more...
HIPAA - Understanding Compliance Program Requirements 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  more...
Project Management for Non-Project Managers 2017 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  more...
Applied Statistics for Scientists and Engineers 2017 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  more...
FDAs Software Monsters Cybersecurity Interoperability Mobile Apps 2017 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.  more...
Validation and Troubleshooting of Pharmaceutical Water Systems 2017 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  more...
Regulatory Requirements and Principles for Cleaning Validation 2017 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  more...
Supplier Management in FDA- and ISO-regulated Industry 2017 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  more...
FDA FSMA Rules Planning Valid Preventive Food Safety Controls 2017 a Understand US FDA final rules for the Preventive Controls for Human and Animal Foods a Define and review your current system to identify gaps in your preventive controls planning. a Be able to develop and implement a valid preventive control company food safety plan to close any gaps a Write and implement appropriate procedures. a Know your requirements for control over your supply  more...
Microbial Control Monitoring Validation and Troubleshooting 2017 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  more...
Statistics for Quality Control and Process Validation Comparing Sets of Data - Webinar By GlobalCompliancePanel The previous webinar converted the process for comparing two results or measurements, but the next question is, "What if there are more than two sets of data to compare?" The answer to this question will occupy most of the following webinars in this series, but there are simple methods to deal with multiple sets of uncomplicated data. This webinar will focus on these elementary methods and serve  more...
Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems - Webinar By GlobalCompliancePanel When was the last time you performed a water system excursion investigation and could not definitively conclude the root cause? If you are like most firms, this scenario was probably your most recent experience, happens quite often, and frankly, is probably completely unnecessary. Price: $225. 00 GlobalCompliancePanel Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.  more...
Auditing Analytical Laboratories for FDA Compliance 2017 Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.  more...
Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems This presentation will explore these possible causes, including the symptoms of real (as well as false) water system problems, and provide effective alternatives to avoiding most of your current superfluous excursions, as well as how to build supporting data useful in pinpointing causes when investigations are indeed necessary. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884  more...
Application Controls throughout the Life Cycle of Application Systems GlobalCompliancePanel brings a new webinar on the topic of Application Controls throughout the Life Cycle of Application Systems. Webinar will be on March 16, 2010. Webinar will be presented by Bernice Russell Bond. Miss. Bond is the President of BRUSSELL Consulting, Inc (BCI), Bernice brings over fifteen years of business operations, risk management, audit and compliance experience. She has  more...
ISO 13485 2003 - A Straightforward Interpretation with Recommendations for Easy Implementation ISO 13485 is a wordy standard, drafted by individuals for many of whom English is not their primary language. This webinar is a section-by-section review of ISO 13485 in a clear concise manner, and provides suggestions for development of a compliant system. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
2-day In-person Seminar on Verification vs Validation - Product Process Software and QMS at Las Vegas This course will evaluate different field-tested, U. S. FDA-reviewed V&V protocols; how to employ equipment/ process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. Price: $1, 295. 00 GlobalCompliancePanel Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel. com Website:  more...
2-day In-person Seminar on Good Laboratory Practice Regulations - Introduction and Strategies for Implementation at Mumbai GlobalCompliancePanel, a leading regulatory and compliance training gateway, will host a two-day, in-person seminar on the topic, a Good Laboratory Practice Regulations a Introduction and Strategies for Implementationa on March 21 and 22 at Mumbai, India. Dr. Steven Kuwahara, founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and  more...
Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel his session will address the latest FDA guidance requirements and expectations and expound on why tracking methods must provide certain critical information about the location of a tracked device. Plus, FDA understands that manufacturers will have different tracking methods and procedures. NetZealous LLC, DBA GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884  more...
Pharmaceutical Manufacturing Batch Record Review - Webinar by GlobalCompliancePanel The FDA and its European counterpart, EMA, require drug manufacturers to have written procedures in place to document production and process controls, better known as batch records. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Developing an Effective Supplier and Internal Auditing System - Webinar by GlobalCompliancePanel This session will detail the best methods or training auditors, and include the best methods for performing internal audits as well as audits of suppliers and subcontractors. GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Managing the IDE Investigational Device Exemption Submission for Compliance Success - Webinar by GlobalCompliancePanel An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Excel Spreadsheet Validation To Eliminate 483s - Webinar by GlobalCompliancePanel 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. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Food Traceability Program and Efficacy Verification - Webinar by GlobalCompliancePanel The purpose of traceability and its value to the brand will be explored. The resources necessary to achieve an effective result will be presented. A customer perspective on the importance of product traceability from a customer perspective will be shared with the attendees to bring justification for team support of these time consuming exercises. NetZealous LLC, DBA GlobalCompliancePanel USA  more...
Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel on-line e-learning cbt (computer based) The presentation illustrates the statistical concepts. The Global Harmonization Guidance document on process validation shows the application of statistical techniques. In particular, the guidance explains the use of design experiments (DOE) to establish process parameters and develop challenge points for the Operational Qualification (OQ) phase. GlobalCompliancePanel USA Phone: 800-447-9407  more...
FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel The labeling regulations, which became effective in late September 2008, clarify that a manufacturer can make unilateral pre-FDA approved labeling changes "only to reflect newly acquired information" when there is "reasonable evidence of a causal association" between the drug or device and the risk. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884  more...
Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel During this 1-hour webinar, we will review the applicable US and EU expectations of documentation plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena. According to the FDA, if it isn't written down, it didn't happen. As well, if it isna ™t written down clearly, it didna ™t happen either. Don't let poor documentation practices become  more...
The 510k Submission Requirements Contents and Options - Webinar by GlobalCompliancePanel This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Preparation for FDA EU Pharmacovigilance Inspections - Webinar By GlobalCompliancePanel This webinar is designed to give pharmaceutical firms operating in the US and EU practical information, practices and insight to help ensure compliance with the most recent drug safety and pharmacovigilance regulations. Tuesday, April 3, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Water Microbial Test Methods Harmonization vs Optimal Quality Control - Your Choice - Webinar by GlobalCompliancePanel Overview: As much compendial test method harmonization as has already occurred with Microbial Limits testing for non-sterile products and raw materials, surprisingly little has occurred with the microbial test methods used for testing water. Both USP and JP recommend methods in their non-mandatory informational chapters, and USP goes a step further to encourage the user to find the best method  more...
Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to a great extent, but not completely. This webinar sets forth the requirements for recalls, removals, and market corrections, and provides recommended practices. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Test Method Validation - Webinar by GlobalCompliancePanel The US FDA and other regulatory agencies are critically reviewing test method validations. Observations like: "Failure to establish accuracy, sensitivity, specificity, and reproducibility of test methods employed by your firm", which appear in Warning Letters and 483 observations demonstrate a complete lack of understanding of the regulatory expectations. GlobalCompliancePanel USA Phone:  more...
Clinical Trial Applications in Canada and Comparison to the US and Europe - Webinar by GlobalCompliancePanel This topic will cover the regulatory submission required in Canada (Clinical Trial Application) and comparison to Clinical Trial Applications in Europe and Investigational New Drug Submissions in the EU. Also covered will be the submission of documentation to Institutional Review Boards, the membership of these boards, and common findings of deficiencies for such Boards. NetZealous LLC, DBA  more...
Excel Spreadsheets - Develop and Validate to Eliminate 483s - Webinar By GlobalCompliancePanel 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. NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone: 800-447-9407 Fax:  more...
Medical Device Classification - US and the EU as per MDD CMDR and GHTF - Webinar by GlobalCompliancePanel The Medical Device Classification webinar explains the classification system in the US, the EU, following the Medial Device Directive (MDD), and the Canadian Medical Device Regulations (CMDR), and the guidance from the Global Harmonization Task Force (GHTF). This is a risk based approach implemented by regulatory authorities. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884  more...
Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar By These topics and more will be addressed during this Webinar, including recently FDA's proposed rule to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product.  more...
Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? GlobalCompliancePanel Phone: 800-447-9407 Fax: 302-288-6884  more...
Implementing GAMP 5 in your Projects - Webinar By GlobalCompliancePanel This webinar focuses on the role of project team members in ensuring that projects are executed to satisfy scrutiny by regulators. After a walkthrough of regulations for good documentation practices, the presentation will transition to a brief explanation of validation enablers as enumerated in ISPE's GAMP V guide. GlobalCompliancePanel Phone: 800-447-9407 Fax: 302-288-6884  more...
Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel This course will include a discussion of the Deviation System, what should be investigated and the level of investigation. Several tools that will lead to the identification of the root cause will be discussed. These include: process mapping, brainstorming, cause analysis, cause and effect and the 5 Whys. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884  more...
Dietary Supplement Regulatory Compliance in the United States Labeling Product Claims Updates from the FDA - Webinar by Global This 90 minute live, interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel This presentation will answer some of the frequent questions of new trainers or training managers. These include: worker training requirements, the frequency of training, how to design an effective training program, who is responsible for training, training effectiveness and training documentation. NetZealous LLC, DBA GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884  more...
Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel This webinar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539,  more...
Laboratory Water Systems Necessary Water Specifications and Validation Challenges - Webinar By GlobalCompliancePanel This webinar will assist the attendees in logically investigating and defining the specific quality attributes their lab water systems need and not just default to manufacturing's required water quality. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Cape Town Seminar on Complaint Handling and Management An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.  more...
Dubai Seminar on The A to Zs of Water Systems for BioPharma Medical Devices and Cosmetics Industries 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.  more...
Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel Overview: This interactive webinar will review the regulatory requirements for an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. Common pitfalls and means of overcoming them at each of the steps will be  more...
Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices. Price: $245. 00 USA GlobalCompliancePanel, Livermore Common, Fremont, CA, 94539 USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Outsourcing Management - Effective Contract Manufacturers Supplier Evaluation Approval and Monitoring - Webinar By GlobalComplia This course will discuss the regulatory expectations and other industrial references/ standards that will impact your system. Then, we will discuss the general requirements of a vendor/ supplier (outsourcing management) control program followed by specific requirements for different types of supplied materials/ equipment/ services and the application of a risk-based categorization system. The  more...
Process Validation for Medical Devices - Webinar By GlobalCompliancePanel Process validation is a powerful technique to help you find the point where your process should operate. In addition, it can help you find the limits of the process. These limits, applied to the process inputs define the parameter space that produces satisfactory process output. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA  more...
The Investigational Medicinal Product Dossier IMPD EU CTA vs FDA IND - Webinar by GlobalCompliancePanel This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
From MentorHealth
Seminar on Tougher Import Rules for FDA Imports in 2016 at Philadelphia PA 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. In 2016 entries must use the Automated Commercial  more...
Seminar on HIPAA for the Compliance Officer at Chicago IL Overview: I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/ Privacy Rule, Areas covered will be 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 much, much, more I will uncover myths versus  more...
Seminar on HIPAA Security Privacy Official - Roles and Responsibilities at Houston TX Overview: Being the HIPAA Security and Privacy Official involves not only ensuring you know the appropriate patient rights and controls on your uses and disclosures of protected health information, but 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  more...
From GlobalCompliancePanel
Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel This program will provide the content for pharmaceutical manufacturing sites to establish sound quality management system procedures for the disposition of intermediates, API, drug substances, medical devices, finished product, and in-house manufactured components. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
The Investigational Medicinal Product Dossier IMPD EU CTA vs FDA IND Comparing the Content and Agency Expectation - Webinar by This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel According to the FDA, if it isn't written down, it didn't happen. As well, if it isn't written down clearly, it didn't happen either. GMP compliance (21CFR, Part 211) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and support areas. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.  more...
Global Medical Device Adverse Event Reporting Systems in EU Canada and US - Webinar By GlobalCompliancePanel This webinar will help you profoundly change your way of planning, developing, implementing and following your relevant and applicable processes in a more efficient and effective manner. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Lowering Clinical Research Professionals Turnover Rate A Condition for Successful Clinical Trials - Webinar By GlobalComplianceP At the end of this webinar, participants will understand some of the issues that create the high turnover in clinical research staff and will get some solutions. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
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