Compliance Training Webinars for Regulated Industries

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.

This webinar will explain the different types of Personnel Files. Attendees will learn about the types of personnel files that need to be separated from other types, and those that require separate security measures.

This training will outline practical steps to design medical device software that does not compromise on performance reliability and patient safety, thereby preventing product recalls.

This webinar will help you Gain a better understanding of your responsibilities as an exporter under the ITAR. Learn about the laws governing defense articles and services, how to comply with the regulations, and develop an effective ITAR compliance program.

This Food Recall training will help you create a robust process for planning and conducting a food recall and crisis communication. It will help each department anticipate their roles and responsibilities so your company’s response will be effective and swift.

This Health Information Privacy Compliance training will provide an outline and roadmap for developing a risk-based approach to compliance.

This training on UK Bribery Act will help you understand its requirements and how it will impact your organization. Learn how to identify areas of risk, proactively mitigate them to avoid significant fines and loss of reputation.

This training on auditing of software vendors for FDA compliance will explain the types of audit and its use in qualifying and selecting vendors. It will discuss sample forms and checklists which may be used by the participants for observations, recommendations and remediation.

This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.

This 4 hour virtual seminar will provide a solid understanding of the USP, its sections and how they are inter-related. Attendees will also learn how to be aware of changes to the USP, and how to influence them.

This Anesthesia Services Compliance training will help you understand what auditors are looking for when they review your anesthesia documentation.

The presentation will consider potential impacts of the rule on regulated and unregulated vendors, and providers. This session will survey the market affected by the proposed rule, and define the common components and capabilities of these systems.

Learn about last changes in Canadian ethics regulations, understand how to apply the change in the day-to-day work.

This course on Controlling Outsourcing Using Quality Principles will help you understand your responsibilities, while outsourcing your products, so that you avoid regulatory problems or customer alienation that can damage your product's reputation.

This webinar on Dry Powder Inhalers will focus on pharmaceutical active particle design, physical characteristics and its relationship with product behavior both in vitro and in vivo.

This ADA Amendments webinar will help you clearly understand the EEOC's final regulations on The Americans with Disabilities Act and what it means to your company.

This training on adaptive designs for clinical trials will help you indentify situations in which adaptive designs would be advantageous and describe the operational and administrative changes to trials under various adaptive designs.

This training will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-dried products in vials, to foods.

This cGMP webinar for medical device companies will focus on recent manufacturing lapses that have resulted in major recalls, multi-million dollar fines and some criminal charges. It will analyze why they happened and show how to prevent it.

This webinar will help you understand the current quality and regulatory paradigm by comparing and analyzing ICH-Q10 Pharmaceutical Quality System and the FDA’s Quality Systems Approach (FQSA) to Pharmaceutical GMPs.