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 Dr Rendon Revive Education
Pharmacy Technician Training with Internship Program instructor led trainingOn the Job Training In 10 short weeks you could be Certified as a pharmacy technician. Our Clients offer Internships to our graduates which often translate into Immediate Career Opportunities with advancement. Our Career Placement Regions are Los Angeles, Temecula, Palm Springs, and San Francisco. Only $ 2450 Financing Available Ask about our Pay Tuition when you get a Job program !  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 Centre for Clinincal Research and Training
Advanced Clinical Research Course in Mumbai instructor led trainingon-line e-learning cbt (computer based)study at homegroup study and discussioncoursewarecd rombookworkshop / seminar ... Undergraduates, Graduates and Post Graduates in Science, Pharmacy, Medicine, Nursing, Management, practicing and working Doctors, Pharma Executives For free counseling, call: 9820960304, 9869260304, 022-27460920 Email: info@ccrtmumbai. com , ccrtmumbai@yahoo. com at Navi Mumbai: 5 Siddhivinayak Subhashish, Plot No. 27, Sector No. 19, Opp. Police Chowki, Matheran Road, New Panvel, Navi  more...
Certificate course in Clinical Research Training at your Convenience correspondence with personal assistance instructor led trainingstudy at homegroup study and discussioncoursewareself directede-bookbookworkshop / seminar Certificate Course in Clinical Research Training, Course at your Convenience ( correspondence with personal assistance) Student doing correspondence can attend a Two 2-day workshopsa ™ in any of our centre. Conducted by CCRT, Mumbai at New Panvel, Navi Mumbai. Course Duration: 4 to 6 Months (Weekend Batches) Course Content: * New Drug Development Process * Phases Of Clinical Trials  more...
Certificate course in Clinical Research, Training, Correspondence Course, with online assistance instructor led trainingstudy at homegroup study and discussionself directede-bookbook Conducted by Centre for Clinical Research & Training(CCRT), Mumbai Course Duration: 2 to 6 months Course Content: * New Drug Development Process * Phases Of Clinical Trials * Study Design And Randomization * Clinical Operations and Project Management * Clinical Data Management * Pharmacovigilance * Bio- Statistics * Regulatory & commercial Medical Writing * Auditing and Monitoring  more...
Fast Track Certificate Course in Clinical Research - One Month Residential Training instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewarebookworkshop / seminar Fast Track Clinical Research Course and Training Course Content Module 1- Phases Of Clinical Trial Module 2- Ethics In Clinical Research Module 3- Clinical Operations Module 4- Clinical Data Management Module 5- Pharmacovigilance Module 6- Medical Writing Module 7- Regulatory Affairs Module 8- Bioavailability & bioequivalence Module 9- Audit & Monitoring Module 10- Soft Skill &  more...
Medical Writing Course and Training, Certificate Course, At Navi Mumbai instructor led traininggroup study and discussionself directedworkshop / seminar ... Undergraduates, Graduates and Post Graduates in Science, Pharmacy, Medicine, Nursing, Management, Practicing and Working Doctors, Pharma Executives. Prerequisit : Good English For free counseling, call: 9820960304 , 9869260304, 022-27460920 Email: info@ccrtmumbai. com, ccrtmumbai@yahoo. com Head Office at Navi Mumbai: 5 Siddhivinayak Subhashish, Plot No. 27, Sector No. 19, Opp. Police  more...
Medical Writing Course and Training At Navi Mumbai instructor led traininggroup study and discussionself directedworkshop / seminar ... Undergraduates, Graduates and Post Graduates in Science, Pharmacy, Medicine, Nursing, Management, Practicing and Working Doctors, Pharma Executives. Prerequisit : Good English For free counseling, call: 9820960304 , 9869260304, 022-27460920 Email: info@ccrtmumbai. com, ccrtmumbai@yahoo. com Head Office at Navi Mumbai: 5 Siddhivinayak Subhashish, Plot No. 27, Sector No. 19, Opp. Police  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...
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...
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...
Designing Alarms in medical Devices to Address the Hospital Concerns - Webinar by GlobalCompliancePanel Different strategies have been used to provide constant monitoring to sick patients in hospitals. Equipment and system designs have often incorporated the use of alarm systems, which alert the clinician when a certain value is outside its target range. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
2-day In-person seminar on The A to Zs of Microbial Control Monitoring Validation and Troubleshooting of Pharmaceutical Water Sy This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it. GlobalCompliancePanel Toll free: 1800 447 9407  more...
Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs - Webinar By GlobalCompliancePanel This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. NetZealous LLC, DBA GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
New EU Pharmacovigilance Directive and Regulations - Webinar By GlobalCompliancePanel This webinar is focused on understanding the new requirements for Good Pharmacovigilance Practices that will begin to become effective in the European Union beginning July 2012. The New Guidance on Good Pharmacovigilance Practices (GVP) has been updated by Module, of which the first seven Modules have been disclosed for public consultation. NetZealous LLC, DBA GlobalCompliancePanel 161  more...
Biosimilar Generic Biologics In The USA Approval Pathway - Webinar by GlobalCompliancePanel This web presentation presents an overview of FDA's requirements for approval/ marketing of a Biosimilar (Generic Biologic) product. The webinar covers the Biosimilar product testing requirements (clinical and nonclinical) and the Biosimilar approval pathway. GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone: 800-447-9407 Fax: 302-288-6884  more...
DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/ DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.  more...
Efficient Failure Mode And Effects Analysis - Webinar by GlobalCompliancePanel It's not enough to do your best. You must first know what to do, and then do your best. The FMEA methodology is so structured; it forces you to identify the right things to do. One of the right things to do is to not repeat the problems of the old designs into the new devices. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
2-day In-person Seminar on VerificationValidation - Product Process Software and QMS at Las Vegas - Seminar by GlobalComplianceP This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/ scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard  more...
Device Changes and the 510k - Webinar By GlobalCompliancePanel The majority of medical devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". NetZealous LLC, DBA GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884  more...
Surviving a DEA Inspection by a Hospice Program BY GCP The Drug Enforcement Administration (DEA) has been focusing on the prescribing of Schedules II narcotic substances by practitioners caring for their patients in a certified Hospice Program where narcotic drugs are prescribed for the individual patient.  more...
Validating Radiation Sterilization for Medical Device Industries- WEBINARS BY GCP Gamma and E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and standards. This webinar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization.  more...
Requirements of validation and control of EO Sterilization - Webinar by global compliance panel Sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies.  more...
How to Survive a DEA Inspection Series Only Manufacturers and Distributors - Webinar By GlobalCompliancePanel This training will cover DEA record-keeping and security requirements that a registrant must comply with when handling controlled substances and regulated chemicals. It covers elements of what occurs during unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling those products, you will get a better understanding of what is  more...
CAPA Failure Investigation and Root Cause Analysis to Meet FDA Expectations - Webinar By GlobalCompliancePanel Expectations for meaningful CAPA, supported by results-driven Failure Investigation and Root Cause Analysis, that addresses and resolves underlying product problems, are growing among regulatory agencies world-wide. Price: $245. 00 GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
Equipment Validation Tracking Calibration and Preventive Maintenance - Webinar By GlobalCompliancePanel The program must include: intervals, scheduling, specific procedures, limits of accuracy/ precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884  more...
Risk Management during device design according to ISO14971 - Webinar By GlobalCompliancePanel In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Price: $225. 00 GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
FDA Requirements for Device Labeling Development Contents Distribution and Changes - Webinar By GlobalCompliancePanel This webinar is designed for those who perform, supervise, manage, audit, or oversee the creation, approval, control of labels and labeling. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com Event Link -  more...
How to Prepare for Manage and Follow-up to an FDA Inspection - Webinar By GlobalCompliancePanel This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. GlobalCompliancePanel USA Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar By GlobalCompliancePanel This webinar demystifies Part 11 and the new European equivalent Annex 11. It gets you on the right track for using electronic records and signatures to greatly increase productivity. GlobalCompliancePanel Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel. com  more...
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