Quality and Safety Regulatory Compliance Training - Live Webinars, Recordings & CDs

This microbial excursions training will address microbial excursion and the best practices for troubleshooting them. Attendees will gain a new understanding of the complexity of troubleshooting outbreaks and contamination issues based on real life experiences and details of specific excursion.

This webinar on objectionable microorganisms will show how to identify and prevent objectionable microorganisms that are beyond the ones outlined in USP <1111>. Attendees will learn the clinical implications due to presence of objectionable microorganisms.

This medical foods regulatory compliance training will explain the regulatory processes to designate and market a product as medical food. Common issues with FDA compliance will be discussed using case studies and potential solutions will be provided.

This virtual seminar will start by evaluating important areas for regulated companies to focus in 2013-2014, based on the U.S. FDA’s recent "Strategic Priorities" initiative. The second-half of the session will discuss how FDA's global initiatives affect supplier chain management and vendor audits and how you can prepare to address them.

This webinar on preparing for FDA inspections will present simple but powerful tools, with real world examples on how to prepare for an impending FDA inspection. You will learn what essential last minute preparation activities can be done and others that should be avoided.

This session on conducting effective GMP trainings will cover proven learning techniques for technical and compliance related trainings. It will answer key questions about how to make GMP training sessions more engaging and even fun for the learners in your organization.

This webinar on dietary supplement adverse event reporting will explain the requirements under federal law as to when serious adverse event reports must be submitted to the FDA, what information and when it must be submitted. In addition, it will highlight the recordkeeping requirements under the law pertaining to all adverse event reports.

This training will outline the best practices in responding to a FDA Warning Letter so the consequences of the findings do not escalate beyond the current status.

This webinar will help you understand the industry background to the current transition to Risk-based Verification processes and the current trend in implementation by industry. You will learn the regulatory foundations, industry guidance, and primary components of risk-based verification as it relates to an overall specification, design, and verification program as outlined in ASTM E-2500-07; “Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment;” ASTM, 2007. Key implementation considerations and initial steps will be discussed.

This webinar will discuss the use of Lean Six Sigma methodology for product complaint investigations and offer a standardized approach for FDA regulated life science companies to follow whenever product complaint investigations are needed.

This 90-minute webinar on personnel practices and microbial control in Pharmaceutical, Biotech, and Medical Device manufacturing will cover effective ways to train personnel on gowning and personnel practices in cleanroom operations to limit contamination. This webinar will also address controlling microorganisms on process equipment and product contact surfaces.

This 90-minute webinar will outline the common deficiencies in relation to method validation, for pharmaceutical products, outline regulatory requirements and the change control process needed to stay in compliance.

This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.

This webinar on pharmaceutical water systems will explain practical best practices for outlet use and sampling to reflect the true water quality and how to most effectively use the resulting data to improve manufacturing’s water use practices and maintain water system control before problems arise from biofilm-related contamination.

This 6-hr training will focus on important microbial issues with pharmaceutical water systems and provide proven solutions for microbial control. Attendees will learn effective sanitation and validation approaches to successfully control biofilm in water systems.

This webinar on Risk Evaluation and Mitigation Strategy (REMS) will help you understand how to adhere to REMS policy, its implementation and submission requirements. It will discuss FDA's current thinking on REMS, how it reduces the REMS obligations for sponsors, and how the agency's requirements and procedures in this area are evolving.

This 120-minute webinar on using the QbD Approach to Analytical Method Lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements.

This 2-hr Dissolution Instrument Qualification webinar will discuss recent FDA requirements for dissolution instrument qualification and provide practical suggestions to avoid pitfalls in performance of the tests, minimize Performance Verification Test and product failures.

This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.

This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.