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

This training on residual solvents will discuss the regulatory landscape for residual solvents and compliance requirements, including interpretation of the majors sections (classes of solvents, options for describing levels, analytical procedures).

This webinar will discuss in detail key auditing elements of an Active Pharmaceutical Ingredient (API) facility/operation. It will cover selection, designation and documentation of starting materials; qualification of analytical methods; control requirements for multi-product/multi-processing API production facility; QA review and release of API and much more.

This webinar will provide the typical elements required to be included in the Batch Production Record and the Device History Record in order to accomplish a quality and cost effective review and quality assessment based on current regulatory expectations.

This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.

This webinar will discuss in detail all parts of the regulations set forth in part 210 and in parts 211 of 21 CFR chapters. Attendees will learn how to comply with these regulations.

This webinar will discuss requirements for supplier and vendor qualifications. Attendees will learn how to develop a risk management plan for monitoring of suppliers, vendors and service providers. It will also discuss how to prevent recalls and advisory notices due to provided non-conforming materials or bad services.

This webinar will explain how to conduct an effective internal audit program. Attendees will learn the benefits of a well-designed and executed internal auditing program for GMP compliance enhancement, management informatics and for avoidance of whistleblower actions.

This webinar will explain how to generate a practical and compliant methodology to handle equipment requalification. Attendees will learn about common pitfalls to avoid when requalifying equipment.

This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.

This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.

This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.

This GLP compliant assay training will help attendees deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts.

This webinar will provide an introduction to the FDA’s regulation of Over-the-Counter (OTC) drug products and the various methods for bringing such a product to market. You will learn the various options for marketing an OTC drug, gain an understanding of FDA’s relevant labeling and promotional rules, and learn strategies for mitigating the potential risk for FDA regulatory enforcement.

This training on medical foods will provide an introduction to FDA’s regulation of medical products, assist you in identifying when it may be appropriate to market a product as a medical food; recommend strategies for marketing such products; and summarize recent FDA enforcement actions in the area to help companies mitigate the risk of potential Agency enforcement action.

This training on FDA compliance will provide the attendees with an understanding of FDA expectations regarding end-of-phase 2A meeting guidance. Attendees will learn the best practices to comply with the intent of the guidance and to achieve a higher quality outcome from the meeting.

This training on Generic Drug User Fee Amendments of 2012 will discuss the new requirements under GDUFA and effect of GDUFA on the Drug Master File (DMF) process.

This webinar will discuss the terms GLP and GMP, their definition, similarities and differences and their application in the biologics or pharmaceuticals development environment.

This webinar on FDA Pharmacy Compounding will detail the current thinking, the efforts made and steps taken by FDA and legislatures since the “meningitis outbreak” in 2012.

This water systems webinar training will discuss the myths surrounding microbial monitoring and control approaches and alert you to the pitfalls of believing these myths which could cause over-confidence in a system’s design for microbial control or the suitability of your microbial test methods.

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.