FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

The webinar will cover requirements for all imported FDA regulated products. Topics covered include required information for FDA’s “Predict” screening program for entry, U.S. Customs Required Information (ACE) program, Harmonized Tariff Schedule, Affirmation of Compliance, and Export Certificate Denial.

This webinar will illustrate ways to take your ongoing or refresher GMP training to well beyond recycling existing content, regardless of your training budget or available resources. By asking a few simple questions of key stakeholders, and tapping into your already creative process, annual GMP training can start to become more than just something everyone has to complete. Come away with a plan to take your program beyond a year-end box-checking exercise and into a resource that people flock towards.

Process Analytical Technology was released by the FDA as a 21st century guideline in September 2004. This guidance was released to help the pharmaceutical industry with real-time release, process understanding, and using the process to ensure all CPPs and CQAs meet compliance, URS, and SOPs. The use of PAT can alleviate strenuous validation procedures by using the process as the function of validation.

This webinar will discuss the basic concepts associated with cleaning validation to facilitate the construction of robust cleaning validation program as well as provide a cost-effective approach on conducting cleaning validation.

This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

This webinar will present an overview of the regulation of in vitro diagnostic (IVD) devices in the United States, European Union and Canada. With a primary focus on IVD regulation by the US FDA, the webinar will cover the classification of IVD devices, an overview of data required for different submission types, and special topics. The webinar will also cover the changes in regulatory oversight in the European Union, and will briefly touch on the regulation of devices in Canada, including recent changes related to oversight of the quality system in that country.

This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.

This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.

The webinar will provide comprehension learning on how to identify and improve your complaint handling process. Learn from an expert the regulations on reviewing, receiving, management criteria for you Complaint Handling Unit. Don’t get caught in being over one-third of firms in 2019 that were issued a 483 and received an FDA Warning Letters citing lack of inadequate complaint handing procedures.

This webinar will illustrate how to use training as a diagnostic tool for improving compliance and efficiency. Learn how to incorporate a few simple yet powerful strategies to help unlock new opportunities for risk reduction, process optimization and improved decision-making. Understand how to collect and then use training data to both advocate for and demonstrate impactful change.

So, we perform Management Reviews because FDA regulations require it? In fact, if you are performing management reviews only to satisfy FDA, you may be complying but you are probably wasting your time. Effective management reviews should have tangible value to the senior executives performing the review. In this online training, we will review how to perform effective management reviews that will assist in the effective management of the company.

This process capability analysis webinar will discuss the relationship between variation and accuracy, and process yield, short term versus long term variation, non-normal distributions and how to perform a process capability study.

FDA regulates how firms advertise and promote their products in social media. It creates a regulatory risk for enforcement action when firm’s step over FDA’s somewhat mysterious advertising and promotion boundaries. What you or someone else says about your product, whether true, false or misleading, becomes a target for FDA’s legal hammer. FDA can levy fines or issue Warning Letters. Even an injunction or prosecution may end up creating a corporate crisis and confusing your customers and drive them away.

In this training program, attendees will understand when and why to apply DOE (design of experiments). They will also learn to identify and interpret significant factor effects and 2-factor interactions and develop predictive models to explain and optimize process/product behavior. Applying efficient fractional factorial designs in screening experiments will also be discussed.

Attend this webinar to get a condensed overview of 21 CFR Part 11 and the key practices that deliver the best results. It will direct you to the most critical and cost-effective methods, techniques and tools available.

This webinar will highlight the importance of quality by design (QbD) concepts via the early establishment of control strategy approach to facilitate the development of robust manufacturing operations associated with biologics and/or pharmaceutical manufacture.

This course will focus on Regulatory Interactions with Health Authorities. It will go over the basic types of meetings, correspondence, and committees which companies may use to interact with Health Authorities.

Attend this webinar to learn how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.