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  • 1 Request Info

    Webinar On Comparability Protocols for Approved Drugs

    This webinar will address approaches to developing comparability protocols for approved drugs, including primary content considerations and timing of submission. The information obtained will enable completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure. The webinar will address aspects of preparing the protocol prior to confirmed changes in order to speed approval and preparing the appropriate updates to Module 3 of the CTD.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 2 Request Info

    Webinar On Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

    This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 3 Request Info

    Webinar On 21 CFR Part 11 - Electronic Record and signature Validation

    This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 4 Request Info

    Webinar On BSA: Marijuana Businesses, Virtual Currency and Model Validation

    This session will offer insights into the application of BSA Requirements on the burgeoning business of medical and recreational marijuana and the silent but effective virtual currency markets and uses, while discussing ways to validate BSA models and applications in monitoring and alerting an institution to potential Money Laundering and other related threats.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 5 Request Info

    Webinar OGMPs for OTC and Cosmetic Products - US and Global Requirementsn

    The cosmetic good manufacturing practice is a set of manufacturing guidelines to ensure the safety and quality of cosmetic products. OTC drug manufacturers, labelers, packagers and holders must comply with good manufacturing practices.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 6 Request Info

    Webinar On Lifecycle Approach to Analytical Methods: Incorporating QbD Principles into Method Development, Validation and Transfer

    This 90-minute webinar on using the Lifecycle Approach to Analytical Methods is designed to provide participants with a lifecycle approach to developing and validating analytical methods with improved outcomes for routine use and transfer.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 7 Request Info

    Webinar on Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

    Overview: Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors, while presenting a fresh new approach to these key and related documents.
  • 8 Request Info

    Two Days Workshop On Statistical Analysis for Process and Product Development

    This course is designed to help scientists and engineers apply statistical methods used to assist decision making in process and product development. Variability must be considered when utilizing data to arrive at conclusions. This course will cover Basic Statistics and Graphical Methods used to summarize data. You will learn how to apply Hypothesis Testing methods to determine whether groups are statistically equivalent or not with respect to key process characteristics such as process averages and variability. Single Registration :- $1,400.00
  • 9 Request Info

    Webinar on Airport Traffic Control Tower - How Air Traffic Controllers Make it Work

    The initial subject focuses on the primary control positions located in the tower. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage aircraft operating on the Airport Movement Area (Ground Control) and within the Airport Traffic Area (Local Control). Also addressed are the operational considerations associated with the close interaction with the Terminal Radar Approach Control (TRACON).
  • 10 Request Info

    Advanced PC-DMIS (CMM)

    This course will help to equip you for a rewarding and challenging position in the quality field. It is perfect for those who have a working knowledge of certain brands of CMM and would like to learn additional brands, as well as for those who would like to enter the CMM field (if prerequisites are met). In this training, participants will expand on their existing knowledge with tips and tricks as well as seldom-used functions to improve performance with respect to productivity (more data in less time) and quality (better data). Special alignments, auto features, constructed features and patterns are all areas of focus. CAD model manipulation and applied GD&T round out the planned topics, always adjusting the training to the skill and experience levels of the participants.
  • 11 Request Info

    Understanding and Controlling Biofilm - Preventing Water System Microbial Problems

    Course Objective: • Poor microbial control in water systems is usually caused by a poor understanding of biofilm. • Poor microbial control in water systems is usually related to poor system design, poor maintenance practices or poor process control levels that allow biofilm development. • Poor microbial control in water systems will eventually lead to process or product microbial contamination, that may in turn lead to high product reject rates, product recalls, regulatory scrutiny, and financial losses due to potential injury litigation and damaged company image. • Cheaply constructed water systems are probably more costly than more expensive water systems
  • 12 Request Info

    Designing Devices for Safety and Zero Warranty Costs

    Course Objective: The legal system, The FDA, and the European standards require the device to be safe as long as it is in use. Therefore high reliability is an obvious requirement. Besides, it is a value proposition for the business: zero warranty costs, safe customers, more loyal customers, and more sales. The FDA reviews the results of the performance tests during pre-market approvals, and in complaint investigations. Therefore a thorough understanding of designing device for long reliable and safe life by the entire staff is critical in efficient business strategy. Course Outline: • WHAT ARE THE DANGERS IN MEDICAL DEVICES ACCORDING TO HOSPITALS • UNDERSTANDING THE SCIENCE OF HIGH RELIABILITY • THE PROCESS FOR DESIGNING FOR ZERO WARRANTY COSTS • THE PROCESS FOR DESIGNING FOR SAFETY • DESIGN CONTROL • PREVENTING FAILURES AND MISHAPS DURING EARLY DESIGN • PRELIMINARY HAZARD ANALYSIS • FAILURE MODE AND EFFECTS ANALYSIS
  • 13 Request Info

    ISO 13485-an Effective Quality Management System

    Course Objective: International interest in certified quality systems is increasing. Many foreign countries are now requesting medical device firms supply them proof of certification to ISO 13485:2003. To apply a CE mark under the Medical Device Directive, 93/42/EEC, certification to ISO 13485 is required in most cases. Course Outline: • Principles of ISO 13485:2003 • ISO 9001 & ISO 13485 Differences • Risk Management & ISO 14971 • FDA’s MDR’s & EU Vigilance • Design Control • Changes Coming?
  • 14 Request Info

    The 11 Must-have Documents of Software Verification and Validation

    Course Objective: Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. A quick review of Internet forums will show much confusion about the subject. Software is being developed for medical imaging, and even thought control of computers. It is increasingly being used for e-records and e-signatures. The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing and validation phases, since replication of software is relatively defect-free. Regulatory auditors are more comfortable with delving into software issues.
  • 15 Request Info

    "Compliance and Policy"

    8.0 – 24.0 hours
  • 16 Request Info

    "Commerciality Determinations"

    8.0 hours
  • 17 Request Info

    Webinar no The 5 Step NLP Sales Process

    Course Objective: The sales process starts by building a rapport, then continues by establishing credibility, uncovering customer needs, and solving problems from a buyer’s point of view. At each step of the process, you must communicate your ability to bring value to buyers. Sales people also need to create value for themselves, as business professionals. This includes managing time effectively, focusing on priorities, and creating a compelling personal vision. Course Outline: We’ll cover the essentials of The 5 Step NLP Sales Process that include the most important, rapport. • Understand and apply a proven selling process • Apply a philosophy to understand the buyer’s point of view • Develop a motivating personal vision as a salesperson • Manage time for profitable action
  • 18 Request Info

    Applied Statistics for Scientists and Engineers - 2-day In-person Seminar

    Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies.
  • 19 Request Info

    Extracting Information from Geochemical Data

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

    Certified Cost Professional (CCP) Exam Review Course

    CCPStudy is a product of 3Fold Education Centre, We are offering certified cost professionals (CCP) or Cost engineering (CCE) exam review course by 100% online. We are the first AACE approved education provider to provide Certified Cost Professional CCP exam review course 100% online. We helped more than 15000 candidates in various international certification preparation and we trained more than 7000 professionals worldwide in online CCP and class room based CCP courses. Our virtual classroom technology can help students to study from anywhere in the world. Our training program consists of the following pre-recorded modules. 3 full length mock exam 10 exam tips and tricks video 40 On-demand video lessons 4 Module wise exams Technical paper draft review (once) Certification application support For further details visit our website