Food, Drugs & Biologics
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Auditing for 21 CFR Part 11
Description: This seminar will discuss the basics of Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation plans, user requirements, test plans, test reports, change controls,... -
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Best Practices in choosing a Regulatory Pathway for your Over-the-Counter (OTC) Drug Product
Description: Over-the-counter (OTC) drug products are sold directly to consumers without the need of a prescription from a healthcare provider. In the US, these products are regulated by the Food and Drug Administration (FDA). Because of the large number... -
FDA Electronic Regulatory Filings Submission – Drug Establishment Registrations and Drug Listings
Description: FDA gives a number of reasons for the decision to move away from paper submissions. These include: electronic review of drug labels for compliance, elimination of data entry errors, and creation of a more efficient and effective process.... -
Drug Master Files: New Implications under GDUFA
Description: The Generic Drug User Fee Amendments of 2012 (GDUFA) were designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. A Drug Master File (DMF) is a submission to... -
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Sampling Plans, from Soup to Nuts
Description: This webinar is valuable for understanding how to calculate and collect samples for any study. This session defines different types of sampling strategies for sample collection. We will discuss how to account for different sources of error, determine... -
Introduction to Measurement System Analysis (MSA)
Description: This webinar is valuable for understanding how measurement system capability studies can be used to validate and represent your system. Identifying the correct methods and sample size will save time and money. A measurement system assigns a number... -
Introduction to Process Capability
Description: Process capability studies are necessary to evaluate the ability of the process to meet specifications. They determine of the process is on target and if the process spread is acceptable. This talk will cover calculation of process capability... -
FDA Foreign Inspections
Description: FDA’s applies U.S. regulatory requirements to foreign manufacturers during an inspection under strict time constraints. A successful inspection requires thorough preparation and practical logistics that can make or break the outcome. If you are not prepared, a failed... -
FDA Warning Letter Management Guide
Description: FDA issues a Warning Letter to tell you that you do not comply with FDA legal requirements. You have 15 working days to tell FDA how you will bring yourself into compliance. This requires drafting a plan that... -
FDA Inspection: Preparation and Management
Description: This webinar is intended to help you get familiar with FDA inspection process so that it can be prepared and managed in a proactive and effective manner. This webinar discusses practical, actionable, and sustainable guidance on how to... -
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Good Documentation Practices for Clinical Trials
Description: This webinar is intended to help you adequately implement Good Clinical Practices (GCP): in particular, documentation requirements during clinical trials for both drugs and medical devices. To adequately implement GCPs, there are a set of standard operating procedures... -
10 Steps to Perfect SOPs: FDA Acceptable SOPs made Easy
Description: This seminar will walk the attendee through 10 critical steps in the development of perfect Standard Operating Procedures. Step-by-step instructions will be provided, with case studies to emphasize the common mistakes and potential solutions. This seminar will help... -
Risk Management in GMP Facilities
Description: This FDA GMP training will help you understand the current requirements for raw material management with tips for practical implementation. It covers FDA’s expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of... -
Marketing FDA Regulated Products Through Social Media
Description: The seminar will discuss the do’s and don’ts for using social media in marketing FDA-regulated products. Common issues, misconceptions, perceptions, and possible solutions will be discussed. In a social media rich environment, manufacturers cannot avoid information dissemination via... -
How to Comply with FDA’s Off-Label Promotion Guidelines
Description: Many FDA approved products have uses beyond what they have been approved for. Manufacturers have to follow very strict guidelines to inform physicians about these additional uses. Manufacturers also have to deal with consumers directly asking for more... -
FDA Expectations from 505(b)(2) Product Development Pathway
Description: A 505(b)(2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and...
