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Your search for 'OTC drug FDA regulations markets import export products monographs labels Rx switch processes' training seminars workshops and conferences in US and Canada has produced the following results.
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Appraisal List and the Engagement Process
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Category: Compliance-Regulation Training Provider: Online Compliance Panel This webinar focuses on the importance of approved appraiser list stratification to enhance appraisal quality and regulatory compliance within the engagement process. One of the primary ways to speed up the review process is to improve appraisal quality. Cost and risk to the institution can also be impacted by the scope of appraisal assignments: matching quality level to transaction.
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Common Problems and Mistakes in Method Validation in Drug Development Process
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Category: Compliance-Regulation Training Provider: Online Compliance Panel Validation of test methods is a critical requirement for the drug development process. Testing of drug substance and drug product for quality requires validated methods. In addition, testing samples for PK/PD studies requires methods that are consistent, robust, rugged, sensitive, and specific in a variety of matrices. Collecting sufficient data prior to validation that can reliably support acceptance require is a frequent issue. Setting appropriate acceptance criteria based on data from final development and qualification is important for assay performance in the validation. This webinar will address issues that arise during development and validation that lead to failure and rework. The webinar also includes approaches to validation that can prevent failure and increase successful completion of validation.
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Enhancing Critical GMP Processes Using Performance Metrics Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel This training program will discuss how to effectively create performance metrics and goals for your department or project. It will also discuss the key components of a metric and when to use different types of performance metrics. The outputs of process performance and product quality monitoring are the key for continual improvement. The necessary changes can be identified, introduced, monitored and controlled to continually improve processes and systems.
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FDA Regulations for Analytical Instrument Qualification and Validation Processes Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors.
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HIPAA Internal Audit Process and Policies: Your 1st Line of Defense Webinar
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Category: HEALTH CARE Training Provider: Online Compliance Panel Learn what it takes for you and your organization to complete an internal audit to determine your risk for non-compliance and to identify policies that need to be added
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IQ, OQ, PQ in the Verification and Validation Process
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Category: Compliance-Regulation Training Provider: Online Compliance Panel This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.
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Planning and Developing Quality System Processes for a New FDA Regulated Facility Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel Learn a practical approach to managing, developing, improving and remediating quality systems, by attending this webinar.
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Process Capability Assessment for Normal and Non-Normal Data
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Category: Compliance-Regulation Training Provider: Online Compliance Panel This webinar discusses methods for estimating process capability for both normal and non-normal data. Pre-requisites for estimating process capability (e.g. establishing process stability) are discussed first. Distributions are briefly described and methods for estimating ppm levels are presented. The use and limitations of common process capability indices (e.g. Cpk and Ppk) are discussed.
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Process Validation - Current Industry Practices and FDA Guidance Document Review Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel Process validation is an important subject for the pharmaceutical quality or regulatory professional. Process validation can be difficult and can cause confusion due to different standards, approaches, and process complexities. In this webinar, the basics of process validation will be explored along with current industry practices. The recent draft FDA Guidance Document on process validation will be reviewed and case studies will be presented that will allow the attendee to see practical examples of process validation protocols.
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Registration & Listing, FDA Inspection Strategies and Compliance Initiatives - Medical Device. - By Compliance Global Inc.
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Category: Compliance-Regulation Training Provider: Compliance Global webinar on FDA Inspection Strategies and how they reach decisions in developing inspection and compliance plans. Registration and how FDA uses this data will be discussed
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Supply Chain Traceability is Going Digital: What Can You do to be Prepared? - By Compliance Global Inc.
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Category: Compliance-Regulation Training Provider: Compliance Global RFID, bar code, satellite, Zigbee, cell phones, tablets, packaging, data loggers, the cloud and other traceability alternatives are now available to provide traceability at the item, case, pallet and container levels.
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Title 19 Customs Duties Parts 200 to End, Revised Webinar
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Category: Compliance-Regulation Training Provider: Online Compliance Panel This webinar will introduce the overview of customs fees and special duties (including Antidumping and Countervailing) and avoid the land mines. CBP has fees and special duties which can create fines and penalties for non-compliant importers. Participants will also get answers to these questions: What is Antidumping? How does it differ from Counter-Vailing duties? What Agencies are involved in ADD/CVD matters? How can an importer stay compliant? Attend this webinar to gain tips for avoidance and mitigation of damages. Also learn rules and best practices.
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Using Behavior based Interviewing to select the Right Candidate - By Compliance Global Inc.
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Category: HR MGMT Training Provider: Compliance Global This webinar will focus on the importance of predicting behaviors of a job candidate by learning how to do behavioral interview and evaluate the answers.
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