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  • 1 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
  • 2 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    Recently the FDA released their draft guidance for industry entitled "Request for Quality Metrics".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
  • 3 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
  • 4 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
  • 5 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.
  • 6 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.
  • 7 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
  • 8 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
  • 9 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
  • 10 Request Info

    Webinar On Use ISO 9004 to Turn ISO Compliance into World Class Performance

    Poor quality is only one of the Toyota Production System's Seven Wastes, and it is the only waste that makes its presence known. ISO 9001 has focused historically on avoidance of poor quality, although ISO 9001:2015 is far more explicit in its requirement for continual improvement of all aspects of organizational performance. The idea of auditing for performance and results rather than compliance with a quality management standard has meanwhile gained recent visibility, although this webinar will show that "rather" is not an issue.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/ISO-9004-ISO-WORLD-CLASS-PERFORMANCE-506043/AUGUST-2017-ES-TRAININGREGISTRY
  • 11 Request Info

    Webinar On Technical Writing for Pharmaceutical, Medical Device and Biologics Industry

    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 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/PHARMACEUTICAL-MEDICAL-DEVICE-BIOLOGICS-INDUSTRY-505657/AUGUST-2017-ES-TRAININGREGISTRY
  • 12 Request Info

    Webinar On Software Validation and 21 CFR Part 11 Remediation Planning: FDA Inspection Strategies

    All computer systems which store data which is used to make quality decisions or data which will be reported to the FDA must be compliant with 21 CFR 11. In laboratory situations, this includes any laboratory results used to determine quality, safety, strength, efficacy, or purity. In clinical environments, this includes all data to be reported as part of the clinical trial used to determine quality, safety, or efficacy. In manufacturing environments, this includes all decisions related to product release and product quality.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/FDA-INSPECTION-STRATEGIES-504251/AUGUST-2017-ES-TRAININGREGISTRY
  • 13 Request Info

    Webinar On Lyophilization: What you need to Know, Validation and Regulatory Approaches

    More and more of today's (and tomorrow's) drugs are biotech drugs, complex and often highly sensitive molecules. External factors such as oxygen, sunlight, and pH values can negatively affect biotech products, leaving marketers looking for innovative ways to protect and preserve these important compounds until they can be administered to patients. The lyophilization process can protect biological activity, extend shelf life, and even increase dosing precision. In recent years, more than 30% of parenteral Food and Drug Administration (FDA) approvals were for lyophilized drugs, and estimates predict that soon more than half of all injectable drugs will require lyophilizationPrice:$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/LYOPHILIZATION-PROCESS-FDA-REGULATORY-508301/AUGUST-2017-ES-TRAININGREGISTRY
  • 14 Request Info

    Webinar On Medical Device Cleanliness: When and How to adjust LIMIT VALUES for Residual Analysis

    This webinar will provide valuable guidance to medical device manufacturers on how to establish and justify limit values for cleanliness. There are several techniques that may be used to set these limits, including comparison involving statistics and historical data. Justification techniques include biocompatibility and risk assessment. Regardless of what technique is used, regulatory agencies expect that limit values will be set for residual analysis.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/MEDICAL-DEVICE-CLEANLINESS-506851/AUGUST-2017-ES-TRAININGREGISTRY
  • 15 Request Info

    Webinar On Mastering the Art of Coaching & Teambuilding

    The leader who understands the value and is able to build a quality team and implement quality coaching of people will build loyalty, develop people and get awesome results.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/MASTERING-ART-COACHING-TEAMBUILDING-504493/AUGUST-2017-ES-TRAININGREGISTRY
  • 16 Request Info

    Webinar On Cleaning Validation Guidelines

    This webinar discusses global Cleaning Validation Guidelines as they are currently available for pharmaceutical and biopharmaceutical industries. In addition, it describes use of QRM (quality risk management) in Cleaning Validation and growing trend of applying this approach to lifecycle of product manufacturing process. Establishing of health based Cleaning Validation limits also discussed in this session.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/CLEANING-VALIDATION-GUIDELINES-503490/AUGUST-2017-ES-TRAININGREGISTRY
  • 17 Request Info

    Webinar On Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations

    Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints!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/COMPLAINT-MANAGEMENT-502650/AUGUST-2017-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar On ISO 9001:2015 Quality Management System: Preparing for a Successful Transition

    In this webinar our speaker Lena Cordie will train on how to carry out a gap analysis against the requirements of ISO 9001:2015 to make the transition smooth and transparent. This exercise will provide your organization with structured assistance to highlight the extent to which existing systems and controls cover the requirements of ISO 9001:2015, or to identify an implementation action plan, where needed.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/ISO-9001-2015-QUALITY-MANAGEMENT-SYSTEM-503857/JULY-2017-ES-TRAININGREGISTRY
  • 19 Request Info

    Webinar On Understanding Proper Aseptic Technique and Cleanroom Behavior

    This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why cleanrooms are designed the way they are.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/ASEPTIC-TECHNIQUE-CLEANROOM-BEHAVIOR-508276/JULY-2017-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar On How to Develop, Document, Implement and Maintain a Foreign Material Contamination Prevention Program

    "Foreign material" is extraneous matter found in food that may render the food unfit for human consumption. Strictly speaking, foreign material is not biological, but metal, paper, paint, glass or other materials. Legally, the term also refers to all contamination of a non-microbial source, including human hair, parts of insects, cleaning fluids and even particles of the wrong food, such as meat in a vegetarian product.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/FOREIGN-MATERIAL-CONTAMINATION-PREVENTION-PROGRAM-502598/JULY-2017-ES-TRAININGREGISTRY