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Courses

  • 1 Request Info

    Webinar On Quality Control of Raw Materials (APIs and Excipients)

    A number of observations on FDA over the past several years reveal that pharmaceutical firms have not been performing adequate testing for incoming APIs, components and raw materials. The regulatory requirements are defined in the GMPs. Because of recognized problems in the incoming material supply chains, the agency is placing more emphasis on material quality. If you make such observations as your base, it appears that some organizations have chosen to ignore/misinterpret the regulatory expectations.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://onlinecompliancepanel.com/webinar/QUALITY-CONTROL-OF-RAW-MATERIALS-APIS-505020/NOVEMBER-2017-ES-TRAININGREGISTRY
  • 2 Request Info

    Webinar On Principles of 21 CFR Part 820 Quality System Regulations

    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. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://onlinecompliancepanel.com/webinar/21-CFR-PART-820-QUALITY-SYSTEM-REGULATION-506042/NOVEMBER-2017-ES-TRAININGREGISTRY
  • 3 Request Info

    Quality by Design using Design of Experiments (QbD) 2017

    This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents. Using a QbD approach for pharmaceutical development studies should include a systematic understanding of the process and using this understanding to establish a control strategy as part of a comprehensive quality risk management program. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901134SEMINAR?trainingregistry-December-2017-SEO
  • 4 Request Info

    Webinar On QSR and ISO Requirements for Supplier Evaluation and Assessment

    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 with this. Many companies can spend much less time and money, and still be in control of their suppliers and in compliance with the regulations. 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:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://onlinecompliancepanel.com/webinar/BEST-PRACTICES-IN-SUPPLIER-MANAGEMENT-508203/OCTOBER-2017-ES-TRAININGREGISTRY
  • 5 Request Info

    Webinar On Outline a Thorough Approach to Complying with Final Rule 504

    This webinar will discuss the background and layout of Final Rule 504 and the requirements of Rule 504 for transaction monitoring and filtering program implementation. It will also discuss the foundation of complying with Final Rule 504.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/FINAL-RULE-504-509581/SEPTEMBER-2017-ES-TRAININGREGISTRY
  • 6 Request Info

    Webinar On Implementing a Metrics Program - Uncovering and Overcoming the Challenges

    Recently the FDA released their draft guidance for industry entitled "Request for Quality Metrics". Much discussion of quality metrics has ensued regarding this guidance and its elements. This presentation provides an integrated view of the aspects of Quality Metrics including the required supporting quality culture..Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/METRICS-PROGRAM-503090/AUGUST-2017-ES-TRAININGREGISTRY
  • 7 Request Info

    Webinar On Top Process Validation Mistakes - And How to Avoid Them

    Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices. We’ll discuss the top mistakes that companies make and how you can avoid them..Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/TOP-PROCESS-VALIDATION-MISTAKES-509627/AUGUST-2017-ES-TRAININGREGISTRY
  • 8 Request Info

    Webinar On Quality by Design (QbD) for Analytical Methods

    There are always certain steps in a method where control is critical either because this step contributes a lot to the overall uncertainty or its uncertainty is more likely to change from common causes. These critical points can be assessed and a monitoring program instituted. This data is then collected and plotted on a control chart. Using Nelson's rules of statistical use of control charts, the individual uncertainties are monitored. This allows for early observation and intervention before a non-compliance occurs..Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/QUALITY-DESIGN-ANALYTICAL-METHOD-502373/AUGUST-2017-ES-TRAININGREGISTRY
  • 9 Request Info

    Webinar On GMP Auditing of Facilities Performing Cell-Based Methods

    Laboratories that perform cell-based methods must meet stringent GMP guidelines for analytical procedures. In addition, standard operating procedures that specifically address working with cells should be in place to maintain control of a live assay system. GMP inspections should cover additional topics in cell-based laboratories to confirm procedures are sound from a regulatory perspective.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/GMP-AUDITING-CELL-BASED-METHODS-506592/AUGUST-2017-ES-TRAININGREGISTRY
  • 10 Request Info

    Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach 2017

    Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system. The various jurisdictions, however, deal with post-market device issues in many different ways. The quality management system, QMS, needs three interlocking process: complaint management, adverse event reporting, and recalls. These processes also have supporting QMS processes such as corrective action and design changes. Overarching the QMS processes are the regulatory requirements, usually involving record keeping and reporting. This workshop covers these primary and secondary QMS processes and analyzes them in terms of US, EU, and Canadian regulations.
  • 11 Request Info

    Drug dissolution testing and establishing plasma drug levels in humans 2017

    Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail.
  • 12 Request Info

    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. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable. One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan.
  • 13 Request Info

    21 CFR Part 11 compliance for software validation and SaaS/Cloud 2017

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements
  • 14 Request Info

    Validation, Verification and Transfer of Analytical Methods 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 method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated.
  • 15 Request Info

    The DHF, DMR, DHR, and Technical File - Design Dossier 2017

    We will consider the following: The Design Control requirements of the CGMPs, 21 CFR 820.30 The Design History File - documenting Product Design Control and its nine elements The Device Master Record and the Device History Record The EU's Medical Device Directive The "Essential Requirements"; and their documentation The remaining elements of a Technical File / Design Dossier Trends Two attendee projects
  • 16 Request Info

    FDA's 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 systems (such as e-cigarettes and vape pens), all cigars, hookah (water pipe) tobacco, pipe tobacco and nicotine gels, among others. The rule went into effect on August 8, 2016.
  • 17 Request Info

    Webinar On USP General Chapter 800 Hazardous Drugs-Handling in Healthcare Settings

    This course will cover the current regulations and importance of preparing and handling sterile and hazardous pharmaceuticals. It will also review the proposed regulation concerning all aspects of handling hazardous drugs and is appropriate for medical, nursing and pharmacy workers. Understanding these regulations will allow users to future-proof their facility and employ best work practices when performing both non-sterile and sterile HD handling.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/USP-HAZARDOUS-DRUGS-HANDLING-HEALTHCARE-505360/AUGUST-2017-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar On Ensure Compliance to FDA's Design Control by using Requirements Management Techniques

    This webinar on FDA's design control requirements will discuss how a requirements management approach consistent with the CMMi requirements management KPA, helps companies meet FDA's design control requirements.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/COMPLIANCE-FDAs-DESIGN-CONTROL-504040/AUGUST-2017-ES-TRAININGREGISTRY
  • 19 Request Info

    Webinar On Risk Management in Clinical Trials: What will inspectors look for?

    Risk management is becoming increasingly important to running clinical trials. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, the revised ICH GCP guideline, recently released EU Clinical Trial Regulation guideline on risk management and several other risk management clinical research standards and initiatives.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/RISK-MANAGEMENT-CLINICAL-TRIALS-506955/AUGUST-2017-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar On Compliance with the CMS Physician Open Payments Rule (Sunshine Act)

    Open Payments is a federal program under the Centers for Medicare and Medicaid Services (“CMS”) that collects certain information relating to payments and other items of value provided to physicians from drug and device companies. Examples include: speaking fees, gifts, meals, and covering the cost of travel expenses to name a few. The Open Payments program also includes information on ownership interests a physician may have in a drug or device company.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/COMPLIANCE-CMS-PHYSICIAN-OPEN-PAYMENTS-RULE-503037/AUGUST-2017-ES-TRAININGREGISTRY