Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10.

The global regulatory environment for tobacco, e-cigarette and e-liquid products is rapidly evolving as legislators and regulators in the United States, European Union and Asia attempt to understand the health and safety concerns presented by these novel products, and develop appropriately tailored laws and regulations. This training course will present an overview of e-cigarette regulations in Asia, the European Union and around the world. It will also detail the key provisions of FDA’s deeming regulations.

The introduction of Vanessa’s Law in late 2014 has significantly changed the enforcement landscape, providing for the possibility of higher penalties than ever before in Canada. This training program will offer an overview of the new law and its potential impact on industry.

This trade webinar will explain the complex US entry process so companies that import FDA regulated products will benefit from a better understanding of how the process works. It will discuss factors and actions that can lead to an import shipment being delayed or not allowed entry into the USA.

This webinar will clarify the cleaning and material handling requirements outlined in USP 797 and present additional best practice guidelines. It will discuss principles related to the selection, preparation and use of cleaning, disinfection and deactivation agents. The correct sequencing of critical activities related to daily and monthly cleaning of both primary and secondary engineering controls will be presented as well.

This webinar will introduce attendees to the basics concepts and techniques of blinding of investigational drug products. It will also provide an understanding of the complexities of the work required to prepare blinded products for clinical trials.

This webinar will provide attendees an overview of the relevant statutes, including the Competition Act, Food and Drugs Act and relevant regulations and information about the existence and operation of Canadian advertising pre-clearance agencies. The rules around advertising and marketing health products will be explained using examples, and hot topics in advertising and marketing will be covered, including the use of social media, testimonials and endorsements.

This course will aid participants in minimizing errors in pharmaceutical and chemical classification under the Harmonized Tariff Schedule (HTS). It will help better protect your company during import/export audits from the government. Participants will also learn how to take reasonable care as an importer and become aware of best practices and red flags in the area of classification for imports into the United States.

This webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system.

This expert instruction on technology transfer of a pharmaceutical manufacturing process will highlight with real world examples hidden traps in technology transfer not covered under its requirements. This webinar will help attendees ensure the success of tech transfer under any circumstance regardless of fields, countries, cultures, and applications.

This course will instruct attendees on establishing an approach to process control within each unit of operation to generate overall process control needed for validation. The webinar instructor, an FDA expert, will enumerate the importance of variation in enhancing a validated means of operation and the parameters that can cause variability. The Randomized Block statistical model will also be analyzed for effective validation.

This webinar on pediatric drug development will discuss relevant laws and FDA's approach to pharmaceutical and clinical development in pediatric patients.

This webinar will cover in detail the current Good Manufacturing Practices (cGMPs) regulations for pharmaceutical products. Attendees will learn how to comply with these FDA regulations and avoid pitfalls.

This webinar will explain how to incorporate a quality system into the validation process to reduce cost and ensure compliance. It will cover the analysis, design and initiation phases, including full implementation of the incorporation.

This webinar will discuss the requirements and general expectations for Stage 2 – Process Qualification, the key concepts that lead to the basis of confidence level and/or statistical confidence and how to apply the concepts in practical use for validation, including acceptance criterion.

This webinar provides a thorough demonstration of what information can be extracted from a surface swab recovery study for maximum leverage in a cleaning and cleaning validation program.

This food safety webinar will explain how to thoroughly review a food contact substance, determine its regulatory status and obtain a new regulation from FDA via the FCN process for a substance that does not meet suitable regulatory status.

This webinar will explain the principles of lean and value stream mapping. Attendees will learn how to apply lean concepts to continuous improvement work across the quality system.

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.