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  • 81 Request Info

    Webinar On Implementation of Risk Evaluation and Mitigation Strategy (REMS) Programs in a Health System

    Pharmaceutical and biologic products may have adverse effects. This can be observed either in general or in specific patient populations. Adverse effects may be related to class and structure and may be observed after approval of the drug. Strategies must be in place if a pharmaceutical or biologic product is deemed to likely have or is observed to exhibit a harmful response in addition to the health benefit. To assure public safety, the FDA requires implementation of a plan designed to mitigate the risk. These plans are developed as part of a risk evaluation and mitigation strategy (REMS).Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 82 Request Info

    Webinar On Effective Corrective and Preventive Action Program (CAPA): The Role of Corrective Action and Preventative Action in Your Quality Management

    Corrective and Preventive Actions (CAPAs) are a beneficial tool for documenting potential problems and investigating them through root cause analysis. Today, more companies are utilizing CAPAs to properly document investigations and capture the action taken by the company. This session will cover the CAPA process, how to implement an effective CAPA system using a risk-based approach and review the key elements of a CAPA report.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 83 Request Info

    Webinar On CMC Considerations for Successful Regulatory Submission

    This webinar is intended to provide advice on the level of detail required for regulatory submissions at different program phases. Regulatory strategy across the development program will also be discussed.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 84 Request Info

    Webinar On Pharma Analytics - I Have All These Data, Now What Do I Do?

    We know that it takes more than a large data set and computer software to effectively solve problems. As information technology increases in capability and availability, the opportunity to use data to develop and improve processes becomes even greater. Particular attention is paid to the pedigree of the data: the process that generated the data, the measurement process and the data collection process including the sampling schemes used.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 85 Request Info

    Webinar On Creating an Effective Contamination Control & Environmental Monitoring Program

    This webinar will provide an overview of environmental monitoring and provide aspects of contamination control. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness. The methods by which clean rooms are monitored are through viable and non-viable testing.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 86 Request Info

    Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

    This webinar will help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET), European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). The webinar will provide the attendee the ability to understand the different LAL testing methodologies, choosing the best test method applicable to the product type, criticality of the BET test result as it applies to the release of a cGMP manufactured product. Who Will Benefit: This topic applies to personnel/companies in the Pharmaceutical, Biotechnology and Medical Device Industries. The employees who will benefit most include: Quality Control Analyst and Management Senior Management Manufacturing Associates and Management Quality Assurance Analyst and Management Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 87 Request Info

    Webinar On FMEA Risk Assessment for Healthcare Decision Making

    Failure Modes & Effects Analysis (FMEA) is a valuable risk assessment process that should be used more often in healthcare problem solving and decision making. This webinar's instructor has worked with FMEA in healthcare settings for the past 12 years. She provides a quick lesson in how to use FMEA, and shares varied examples of benefits for you and your organization.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 88 Request Info

    Product Quality Reviews

    Periodic Product Quality Reviews or Annual Product Reviews of drug products are required by the U.S., EU and Canada. If used effectively, these reviews can be a powerful Quality Assurance tool. The Product Review Process includes: Process Performance and Product Quality Monitoring, Corrective Action/Preventive Action, Change Management and Management Review which are enablers identified in ICH Q10, The Pharmaceutical Quality System. It also includes the ICH Q10 enablers of Knowledge Management and Quality Risk Management. Contemporary guidance suggesting that the Annual Product Review can support the concept of Continued Process Verification and Quality Metrics. The purpose of the course is to educate the participant in the regulatory requirements for the Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as a Quality Assurance and Quality Improvement tool.
  • 89 Request Info

    European Quality Submission Requirements

    This course will provide participants with an appreciation of the key quality considerations for EU regulatory dossier submissions for marketing approval, with an emphasis on elements where specific European requirements additional to ICH guidelines must be factored into the Common Technical Document (CTD). EU guidelines impacting drug substance and starting materials, as well as the use of the CEP (Certificate of Suitability) and ASMF (Active Substance Master file) filing routes will be covered, along with quality requirements applicable to specific types of drug product filing. Challenges presented to the global dossier by key differences between EU and US regional quality/CMC requirements in the CTD, as well as through EU product information and labelling requirements will be analysed in detail. Other specific types of regulatory interactions involving quality submissions (e.g. method of sale ‘switching’, batch specific requests, QP Declarations) will be discussed also.
  • 90 Request Info

    The Regulated Medical Marijuana Business - An Educational Seminar from Concept to Product Sale

    Upon completion of this course, each participant will have an in-depth overview and understanding of the medical marijuana industry starting with the business concept and ending with product sale. Tools, methods and techniques will be employed throughout the course topics to help ensure the planning and execution process is completed in a timely manner while avoiding the typical pit falls that increase cost and extend schedules. Generally acceptable good manufacturing practices and good engineering practices will be integrated throughout the course to provide a robust and repeatable process for compliance with maximum uptime to enable a return on investment. Employee training, building system commissioning and validation, security, cleaning, sanitization and other Standard Operating Procedures (SOPs) will be introduced.
  • 91 Request Info

    Webinar On Auditing for Microbiological Aspect of Pharmaceutical and Biopharmaceutical Manufacturing

    The webinar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 92 Request Info

    Webinar On Understanding European Filing and Registration Procedures for Drug Approval

    Registration and applications within the European Union can follow various procedures depending on the type of product and the objectives of the sponsor. The pharmaceutical industry is one of the highly regulated industries, with many rules and regulations enforced by the government to protect the health and well-being of the public.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 93 Request Info

    Webinar On Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

    Attend the webinar to get a proper contrast and comparison of GMP and Good Laboratory Practices (GLPs), CFR part 58, for conducting nonclinical laboratory studies that support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 94 Request Info

    Webinar On Mandatory GMO Labeling: Preparing for Implementation

    Public and scientific opinion on GMOs in the US is controversial and GMO labeling requirements have been a subject of much debate in the country. One of the U.S. states just enacted a GMO labeling law and a new Federal GMO Labeling law was passed in July 2016. Attend this webinar to learn about the status of GMOs in the U.S., how they are regulated by the FDA, FDA's Biotechnology Policy and Biotechnology Consultation program and GMO labeling in other countries.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 95 Request Info

    Webinar On Implementation of Document Control Systems

    Regulations mandate effective content control. In an era of continuous flow of information and a regulatory guidance for Knowledge Management (KM) as an enabler of Pharmaceutical Quality System (PQS) Pharmaceutical and Biopharmaceutical firms realize the need to have easy to use Document Control and Management Solutions (DCMS).Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 96 Request Info

    Webinar On Design and Execution of Stability Studies for Biologics

    Stability of biologics is necessary to ensure safety of products throughout their shelf life. This presentation looks at the design of stability studies in accordance with ICH guidance and regulatory expectations. Recommendations will be provided on the types of methods that should and should not be included on stability based on degradation pathways and how to set appropriate specifications.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 97 Request Info

    Webinar On Auditing Clinical Trials for Good Clinical Practice (GCP) Compliance

    Audits from either regulatory bodies and/or the sponsor companies are usual during the development of a clinical trial. The results of an audit affect both, the site and the sponsor of the clinical study. Good preparation for an audit starts from the beginning of the trial by identifying the risks of noncompliance.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 98 Request Info

    Webinar On Test Methods and Standards for Medical Device Design Verification and Validation

    Design Verification and validation for medical devices is an integral part of the medical device quality system in FDA and other global compliance requirements. FDA's Quality System Regulations, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485 have specific product verification and validation standard requirements that must be fulfilled. These standard requirements along with an insight into the test methods used to fulfill the design control requirements will be discussed in this important webinar.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 99 Request Info

    Webinar On The balanced scorecard (BSC)

    This presentation introduces participants to the Balanced Scorecard strategic planning methodology. It is designed to give participants the tools and skills they need to help their organizations increase focus on strategy and results, improve organizational performance, align the work people do with organizational strategies, improve communication of the organization’s vision and strategy, and prioritize activities.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 100 Request Info

    Webinar On Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects

    This webinar will cover what is important in facility design from the FDA and regulatory standpoint. You will understand what FDA looks for during a facility inspection. You will be able to minimize possible design errors which are difficult and expensive to fix post-build. Understand what FDA looks for in reviewing the facility design and the flow patterns.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link