Industries
Refine Search
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions
Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.Learning ObjectivesDiscuss what to do when problems o..
Deviation Management – Investigations to Root Cause Analysis
The fundamental failure identified by regulators evolves from companies not knowing how to conduct investigations, how to identify the root cause, and how to select actions to correct the problems such that they never recur. The key to performing effective investigations is the timely gathering of all the facts necessary to understand what happened, and more importantly, what is wrong before we can begin to..
Device and Software Changes and The 510(k)
This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results-driven 510(k) / change analysis activities, based on the U.S. FDA has its current two recent “Final Guidance for Industry and FDA Staff”: “Deciding When to Submit a 510(k) for a Change to an Existing Device”; and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device..
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how Disaster Recovery and Business Continuity Planning should be carried out. This is necessary to protect against the onslaught of threats and attacks, both from natural disasters ..
Diversity & Inclusion Excellence Through Social Intelligence
For you to achieve outstanding diversity & inclusion results requires strong social intelligence, the ability to evaluate and influence other people’s social interactions. Our evolutionary background has resulted in unconscious bias and other problematic mental patterns (called cognitive biases) that lead to tribal behaviors, undermining D&I initiatives. To deal with tribalism, pioneering organizati..
Diversity & Inclusion Strategy: A Necessary Workplace Survival Tactic
What do we mean when we think about – Diversity? Inclusion? Is it referring only to race, disability, and gender? Diversity and inclusion strategies have expanded to include the differences among us in the way we do our work, how we think, as well as where we work in the organization. This webinar will discuss the forms diversity and inclusion take within our workplaces, and how that translates into the cri..
Diversity and Inclusion
Diversity and inclusion are hot topics in organizational design and development but are often misunderstood. This course will guide participants through the basic tenants of diversity and inclusion in practice.We will discuss the difference between diversity and inclusion, the differences in inequality and equity, conscience and unconscience bias, and areas of potential growth. Participants will leave with ..
Diversity and Multiculturalism in HR Leadership
In this program, we will evaluate diversity, multiculturalism, generational assemblage, and other forms of employee inclusion. We will consider the different forms of diversity and inclusion, the various meanings of diversity and inclusion, how to begin the conversation, how to maintain an inclusive workforce, how to raise the “return on investment” topic in an unfriendly atmosphere, and best practices for ..
Does Anyone Care About SOX Anymore?
Many people feel that the task of documenting their company’s Sarbanes-Oxley controls has become routine and downright boring. However, the SOX documentation process remains one of the best ways for CFOs and CEOs to be comfortable in signing off documents that make them personally and criminally responsible for the accuracy and reliability of their public company's financial statements and the effectiveness..
DOL & New Regulations! Best Practices for 2019!
The regulations above are just a few of laws changed, revised or newly developed. Employers are impacted by a minimum of 8-26 regulations or more in 2018! Learn how you can manage the many laws that impact your organization by attending this webinar.Describe topic importance, how this can add value to the work style.Employers must arm themselves with the workplace regulations that will impact their organiza..
Domestic and Foreign Medical Device Regulatory/Reimbursement Strategies
In general, all commercial medical devices require regulatory approval, for obvious reasons. Of equal importance, is to have a reimbursement pathway in each country where the device sale is targeted. One must get a reimbursement assessment early--while still in the product design phase. One must understand how your device may or may not fit within current payment methodologies such as DRGs, resource-based r..
Drafting Document Retention Policies
The presentation reviews the basic approach of Information Governance and the importance of getting the relevant stakeholders at the table when drafting a document retention policy. We discuss the importance of document destruction and how to develop a policy that balances the interests of the various stakeholders.Areas CoveredInformation GovernanceObjectivesPolicies and ProceduresRecords Retention and Dest..
Drug or Cosmetic? Promoting Health Benefits in Personal Care Products
FDA has a history of avoiding discussion of popular issues and leaving the course of history to the imagination of the industry to push the boundaries of regulatory compliance. The unwillingness by FDA to address issues like “natural”, “probiotic”, “CBD” and other popular issues, creates an opportunity to add market potential, but it also creates hazards to avoid for FDA regulated products. Assuming that di..
Drug Product Performance, In Vivo: Bioavailability and Bioequivalence
Drug product performance, in vivo, is defined as the release of the drug substance from the drug product leading to the bioavailability of the drug. The evaluation of drug product performance relates bioavailability to the therapeutic response and adverse events. Bioavailability and bioequivalence studies are measurements of drug product performance and can be used to evaluate new drug formulations, changes..
Due Diligence Steps for Form 1099 Compliance
Form 1099-MISC compliance is a surprisingly complicated compliance requirement for businesses and accountants. The requirements are always changing, and answers are seldom clear-cut. This course will de-mystify some of the tricky areas relating to Form 1099-MISC, such as when 1099 should be issued and whether a worker is a contractor or an employee. The main focus of this presentation is on “box 7” (indepen..