Webinars

FDA Internal Complaint Handling

FDA Internal Complaint Handling

Join this webinar to learn approaches to setting up an internal complaint-handling system that ensures compliance with all GMP requirements.
Japan: Regulatory Compliance Requirements for Life Science Products

Japan: Regulatory Compliance Requirements for Life Science Products

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
Developing Practical and Successful GCP and GVP Audit & Inspection CAPAs

Developing Practical and Successful GCP and GVP Audit & Inspection CAPAs

This Webinar will focus on how to use SMART goals as a framework to draft submission-ready GCP and/or GVP CAPAs that not only adequately address observations but are also practical given your organization’s unique goals and challenges. Anecdotes and examples will be provided to lend context, and tools shared to give you the confidence to write successful CAPAs.
State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs

State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs

This webinar will showcase the importance of State of the Art in Clinical Evaluation Reports for Medical Devices and provide tools and recommendations for writing a well-structured SOA setting the stage for the entire CER. The webinar will also provide recommendations to build a State-of-the-Art Library for your medical device portfolio.
Writing Effective SOPs for the Medical Device and Pharmaceutical Industries

Writing Effective SOPs for the Medical Device and Pharmaceutical Industries

This webinar will help you to write clear, concise, and flexible SOPs. You will learn techniques for creating easy to read and clear SOPs your employees can easily follow. Well written SOPs ensure that your employees understand and consistently follow your manufacturing processes.
The Identification and Quantitation of low-level compounds for Impurity and Degradation Analyses

The Identification and Quantitation of low-level compounds for Impurity and Degradation Analyses

In this webinar attendees will learn the impurity and degradation product analyses tests on compounds of low concentrations for Identification and Quantitation. This webinar covers the approaches and the validation issues that must be met and maintained. Identifying and quantitating minor components is mandatory. The use of a valid approach with its backing by validation ensures that these analyses will be acceptable.
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

This training program will provide attendees with a better understanding of the current audit techniques used by FDA and how they have changed over the years. In addition, areas of increased regulatory scrutiny will also be discussed such as data integrity issues. Additionally, the webinar will provide an overview that companies can use to evaluate their own state of compliance by knowing what have been the most common cited GMP deficiencies over the last several years.
Food Allergen Programs - Current Trends, Technologies and Risk Mitigation

Food Allergen Programs - Current Trends, Technologies and Risk Mitigation

In this webinar, learn how to develop an Allergen Control plan which is a critical component in your product safety initiatives. Understand how to implement, audit, enforce and update it continually.
ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements?

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements?

This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2012 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.
10 Tips for Successful Hospital Utilization Management:  From Foundation to New Trends

10 Tips for Successful Hospital Utilization Management: From Foundation to New Trends

Attend this webinar to understand hospital utilization management despite demanding payers doing everything they can to deny payment through denial of medical necessity. Learn about the best model of case management, denial management, and best practices in clinical reviews.
Statistical Justification for Using Small Sample Sizes and only 3 Lots in Process or Product Validation

Statistical Justification for Using Small Sample Sizes and only 3 Lots in Process or Product Validation

In this webinar attendees will learn a statistically valid method for justification of small sample sizes for use in product or process validation studies (e.g. performed during design verification phase of design control). A different method will be explained for how to statistically justify the number of lots or batches used in such studies, a number that can be as low as 3.
Pharmacokinetic Principles in Preclinical Safety Assessment

Pharmacokinetic Principles in Preclinical Safety Assessment

This webinar will describe the basic principles of pharmacokinetics, with specific emphasis on issues that can impact toxicokinetics in preclinical safety assessment studies. It will highlight methods for the optimization of physicochemical properties in the discovery and development of oral drug candidates and explore some of the preclinical methods used to select first in human (FIH) doses.
Process Validation - Overview of Why and How

Process Validation - Overview of Why and How

This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
Risk-based Design Control - The New Paradigm for Medical Device Design

Risk-based Design Control - The New Paradigm for Medical Device Design

This webinar about risk-based design control reviews the FDA’s and ISO’s guidance and regulations and provides practical ways to implement a robust risk-based design control in your company. It shows you practical ways to simply work and hand and enough spend time on actual risk management and mitigation.
Surviving an FDA Sponsor Inspection - Training for Success

Surviving an FDA Sponsor Inspection - Training for Success

This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.

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