Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

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 cover the current FDA requirement for raw materials used in producing APIs and drug products. Attendees will learn how to ensure that raw materials are of acceptable identity, quality and purity before use. This webinar will also provide best practices for avoiding FDA warning letters and 483 observations.

This webinar will highlight the distinctions between ISO 13485 and FDA’s QSR. It will further introduce attendees to key clauses and requirements pertaining to the two regulations and also detail internal audit requirements.

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 webinar will help ensure attendees are familiar with new regulations for running clinical trials in Europe. It will help them prepare to implement the new requirements efficiently while elaborating how clinical trials will be authorized in the future. The instructor will also detail the authority proffered to EU regulators to perform inspections of all clinical trials registered in the EU, whether they are conducted within the EU or internationally in other emerging markets.

This comprehensive study of the clinical supply process will address increasing efficiency in packaging and labeling. It will also detail compliance requirements that have to be met in the process. Participants will enjoy the opportunity to train under an industry expert and understand solutions for some of the most common challenges in the process.

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 FDA compliance webinar will discuss in detail the guidance on recognition and use of consensus standards. It will focus on the topics such as voluntary conformance, declaration review and content of declaration of conformity.

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 provide clarification on which medical device facility or establishment must register and list, how to register and list, and how to coordinate the payment process to accomplish the actual registration or device listing.

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 EU filing and Registration webinar will discuss in brief all the new EU clinical directives, its Impact and how companies can effectively align their filing and registrations processes to effectively implement the requirements of the regulations.

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.