Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.

Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.

This webinar will discuss pharmacokinetic principles of systemic drug absorption and its applications to the development of oral dosage forms. It will also provide practical examples to show how pharmacokinetics of oral absorption can be applied to drug product development.

This webinar will help attendees understand FDA recommendations and requirements concerning the safety and quality testing of cosmetics. Attendees will understand different types of cosmetic testing, when they are applicable and related compliance requirements.

This webinar will cover federal laws and DEA regulatory requirements for practitioners prescribing Schedules II controlled substances for a patient in a certified Hospice Program and the role of the nurse as an authorized agent of the practitioner.

This Regulatory compliance training is designed to provide an overview of the regulatory environment throughout Europe and will explain how the EU interacts with national regulatory agencies.

This webinar covers the excipients and APIs regulatory requirements, audit planning and execution, basic to advanced auditing techniques, with emphasis on advancing the auditor’s people-skills, effectiveness and reporting skills.

This webinar will provide an understanding of the key European market’s approach to pricing including the details of Pharmaceutical Price Regulation Scheme (PPRS). It will further discuss the key issues shaping the future of HTA policy in the UK.

This training 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 webinar will provide an overview of SEC Whistleblower Rules such as False Claims Act, Dodd-Frank, Sarbanes-Oxley and Commodity Exchange Act. It will also discuss best practices on how to mitigate damages from an actual or purported whistleblower.

This webinar will focus on the federal laws and regulations enforced by DEA pertaining to Schedules II though V controlled substances that is dispensed, or prescribed by a physician as part of a pain treatment plan. Upon completion of the webinar, attendees will be familiarized with the necessary documentation that should be noted in the patient chart and steps to prevent diversion of the dispensed or prescribed drugs.

This webinar will focus on the specific types of writing responsibilities available in industry. It will help attendees understand the medical writing profession and in determining if medical writing or technical writing is a good fit for each of them.

This training program will discuss in detail the method for predicting plasma drug levels from in vitro dissolution results. It will also provide details of the underlying scientific principles involved such as convolution, deconvolution and IVIVC with simple practical examples.

This webinar will explain how to use ANSI/ASQ Z1.4 to define sampling plans including its switching rules. It will also offer an inspection plan format that reduces the sequential sampling plan to ten or fewer rows in most cases.

This webinar provides an overview on the different types of water systems used in the pharmaceutical industry. Attendees will be provided a comprehensive overview of the different types of water systems, their validation, and handling of excursions.

This training program will provide an overview of 21 CFR 111 regulatory requirements which governs how dietary supplements are manufactured and tested. It will futher review the test procedures and documentation requirements to ensure regulatory compliance.

This webinar will discuss the details of specific excursion investigation for outbreaks of molds, vegetative bacteria, and Bacillus.

This webinar will cover US FDA and Customs legal import requirements including discussion on FDA product codes, Custom's Harmonized Tariff Schedule (HTS) and Affirmation of Compliance (AOC). It will also provide information on FDA's software screening program, PREDICT, and U.S. Custom's ACE program.

This webinar will focus on most trustworthy open access resources. It will also provide tips on how to gain access to hard-to-find materials by paying high subscription or membership fees.

This training program will address when to exclude outlying data points from an analysis. It will illustrate how best to apply sensitivity analysis to determine the impact of removing data. Participants will learn to perform and interpret hypothesis tests for outlier detection.