Making Data Driven Decisions using Statistical Hypothesis Testing
Steven Wachs
60 Min
Product Id: 704211
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.
Risky mistakes with Medical Device Compliant Handling -- Challenges in Understanding Compliant Procedures
Rita Hoffman
90 Min
Product Id: 706340
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.
Training as a Diagnostic? The Hidden Gems of Determining Effectiveness
Mike Kent
60 Min
Product Id: 706339
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.
Effective (and FDA Compliant) Management Reviews
Larry Stevens
60 Min
Product Id: 705646
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.
Process Capability Analysis, and What to Do if it's Not a Bell Curve
William Levinson
60 Min
Product Id: 705157
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.
Off-label Promotion in Social Media - Broken Boundaries
Casper Uldriks
3 Hrs
Product Id: 706357
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.
3-Hr Virtual Training: Introduction to Design of Experiments
Steven Wachs
3 hrs
Product Id: 704847
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.
Practical Application of 21 CFR Part 11
Don Hurd
60 Min
Product Id: 706383
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.
Control Strategy Applications for Robust Manufacturing Processes
Victor Olatundun
60 Min
Product Id: 706336
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.
Regulatory Interactions with Health Authorities
Martin Lessem
90 Min
Product Id: 706330
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.
FDA Compliance and Mobile Applications
Carolyn Troiano
90 Min
Product Id: 706318
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.
Surviving an FDA Sponsor Inspection - Training for Success
Stephen Schwartz
105 Min
Product Id: 704516
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.
Effective (FDA Accepted) Responses to FDA-483's and Warning Letters
Larry Stevens
60 Min
Product Id: 705629
This webinar will provide an overview of how to prepare effective responses to warning letters that FDA will consider acceptable. It will help you know how to negotiate with FDA to effectively close Warning Letters.
Self-certified 510(k) Clearance for Devices
Casper Uldriks
60 Min
Product Id: 706356
Firms must develop criteria to determine whether they meet FDA’s qualification requirements to participate in this expedited 510(k) clearance process. This program requires a firm to develop and implement a rigorous initial and ongoing quality assurance program. Attend this webinar to learn how to.
Comparison Between the EU and FDA Regulatory Protocols
George Yanulis
90 Min
Product Id: 706297
This webinar compares the EU and FDA regulatory protocols to help individuals involved in manufacturing, customer service, quality assurance roles to streamline their understanding of the rapid and ongoing regulatory changes being adopted by all medical device regulatory bodies where manufacturers sell and manufacture their devices.
Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry
Robert J Russell
90 Min
Product Id: 702038
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
Charity Ogunsanya
90 Min
Product Id: 703885
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
Practical Fundamentals for an Effective and Efficient On-the-Job Training Program
Mike Kent
90 Min
Product Id: 706324
This webinar will identify elements critical to both the compliance and effectiveness of an On-the-Job Training (OJT) program and provide practical strategies for implementing them efficiently and sustainably. Whether your training program is just getting started or is highly mature, the tools and ideas presented here will help you optimize its effectiveness while reducing compliance risk.
Risk Management in Pharmaceuticals and BioTech
Martin Lessem
90 Min
Product Id: 706325
This course will focus on Risk Management in the Pharmaceutical and BioTech space. It will cover Risk Management Programs and also managing general regulatory risks in the drug development process.
Developing a Strategic Approach to FDA Compliance for Computer Systems
Carolyn Troiano
90 Min
Product Id: 706124
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, which is critical in order to be able 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. We will discuss the phases within the SDLC, and how these form the basis for any CSV project that you may undertake, and the importance of the sequence of steps will also be covered, to ensure you are able to comply with FDA expectations.