Pre-Formulation and Formulation Development of Small and Large Molecules for a Lyophilized Product
J. Jeff Schwegman
90 Min
Product Id: 702305
This webinar on lyophilization technology will provide you the understanding physical properties of formulated products through the use of very specialized analytical techniques. Also attendees will learn pre-formulation assessment, pre-formulation studies including choosing an optimal solution pH and buffer system, solubility enhancement, controlling oxidation, and bulking agents.
Production and Process Controls - Ensuring your medical device conforms to its specifications
Denise Wrestler
90 Min
Product Id: 706028
This presentation will cover the FDA regulations (21 CFR Subpart G Section 820.70) regarding production and process controls and how each requirement listed within the regulation can be addressed. We’ll go over examples of documentation you can use to fulfill the requirements of this section, as well as tips and tricks to what FDA auditors will look for when they come to visit your site. We will also go over some additional tips and tricks on how to convey the importance of maintaining production and process control within your organization and ensure resources are provided to meet process needs. At the end of the presentation, I will answer any questions or concerns you may have regarding FDA requirements.
How to Build a Communication Plan for an Ethics Breach- Preparing for Ethical and Fraudulent Acts
Jack Healey
60 Min
Product Id: 706050
When an ethical lapse occurs, and a Board of Directors and Executive management have to respond, a response plan which includes a communication plan is a requirement. If you want to become more proficient at managing crisis incidents as a result of ethical and fraudulent acts, this webinar is a must-attend.
Investigating and Preventing Sexual Harassment Claims in the Workplace
Janette Levey Frisch
90 Min
Product Id: 706027
In this webinar, you will learn what actions you should take when you receive complaints of sexual harassment and how you can proactively ensure a work environment that is free of harassment.
The Brazilian Reimbursement System
Eliana Silva de Moraes
90 Min
Product Id: 706031
In this webinar attendees will learn the legal and regulatory framework for reimbursement system in Brazil to have better and effective result when marketing with medical and drug product in Brazil.
Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results
Gregory Martin
120 Min
Product Id: 702360
This training on pharmaceutical laboratory OOS investigations will explain how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.
Contemporary Case Management Staffing and Models: Best Practices in the Era of Value-Based Purchasing
Toni Cesta
60 Min
Product Id: 705424
This webinar will review contemporary, best practice, case management models including descriptions of the two most commonly used models, the key differences between the models, as well as how they should be designed and structured. The webinar will also discuss the steps needed to re-engineer a case management department and tips for identifying the best model for your organization.
Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP
Laura Brown
60 Min
Product Id: 701982
This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.
Credit Risk Discipline Tools - Implementing 14 Tools for Credit Risk Management
Dev Strischek
60 Min
Product Id: 705882
This webinar will help you to build, implement, and maintain strong credit culture. This course offers 14 tools to test and check the strength of the organization’s credit risk management and techniques for remediating and improving credit culture and credit risk management.
New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products
Angela Bazigos
90 Min
Product Id: 704529
This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.
Implementing Compensating Controls to Reduce Risk and Prevent Fraud
Chris Doxey
60 Min
Product Id: 706021
Attend this webinar to learn about compensating controls with specific examples and what are the segregation of duties controls. You will also learn how to implement compensating controls to reduce risk and prevent fraud in your internal controls programs.
How to Build a Cyber Security Communications Plan
Jack Healey
60 Min
Product Id: 706019
Attend this webinar to learn the role of the cyber communication plan during a cybersecurity incident. You will learn the type and elements of a cybersecurity communications plan and how to reduce the costs associated with communications during a cybersecurity incident.
Valuing and Implementing Social Media Etiquette Today
Cristina Cain
60 Min
Product Id: 705867
This webinar will help you in creating Social Media strategy for your business at all level of management. You will learn Social Media Guidelines, Social Media Do’s and Don’ts, Social Media Policy, Reputation Management and how to avoid Social Media Mishaps.
Best Practices in Nursing Documentation: Writing Effective and Legal Proof Notes
Laura S Hargraves
60 Min
Product Id: 705138
This healthcare documentation webinar will discuss how to create a lawsuit-proof, auditable nursing documentation and how to maintain compliance over the course of the document life-time. You will learn how to de-risk your documentation so as to withstand legal scrutiny.
Archiving GLP Records: How Archiving Makes or Breaks the Audit
Marschall Robyn White
60 Min
Product Id: 706020
In this webinar attendees will learn the GLP requirements for records archiving, discuss common errors many companies make when archiving GLP record, the options for archiving electronic and manual records, and how archiving practices may impact an audit. Also attendees will receive tips on proactive steps they can take to avoid common pit falls and how records readiness can facilitate a smooth audit process.
Chief Compliance Officer: What does it take to do the job? The Organization's and CCO's Responsibilities
Laura S Hargraves
60 Min
Product Id: 703303
This webinar will explain how to select an effective Chief Compliance Officer (CCO) or Chief Risk Officer (CRO) best suited to the position. It will also review the skills needed to communicate the essence and structure behind a good compliance program.
CMS Hospital QAPI Worksheet and Standards
Sue Dill Calloway
2 hrs
Product Id: 705715
This CMS QAPI standards webinar is designed to help surveyors assess compliance with the hospital CoPs for QAPI(Quality Assessment and Performance Improvement). This worksheet is used by State and Federal surveyors on all survey activity in hospitals when assessing compliance with the QAPI standards including validation and certification surveys.
Container Closure Systems for Liquid and Lyophilized Products
J. Jeff Schwegman
60 Min
Product Id: 702082
This webinar will discuss various container closure systems that are available for use with liquids and lyophilized products, the components that constitute a container closure system and also cover specialized delivery systems.
Contrary to Popular Belief, Workplace Bullying IS Illegal: A look at bullying, violence, and harassment (and how to detect and stop them)
Catherine Mattice Zundel
90 Min
Product Id: 706018
In this HR compliance webinar attendees will learn the behaviors, consequences and myths about workplace bullying & how to develop an effective strategies for dealing with workplace bullying and steps to eliminate workplace bullying for building a healthy workplace where employees can thrive.
AML Investigations and SAR Preparation
Armen Khachadourian
90 Min
Product Id: 704406
This training program will provide guidance in recognizing, investigating and reporting suspicious activities. It will also discuss instructions on implementing and maintaining an enterprise wide compliance program to safeguard the financial system from illicit use and combat money laundering and promote national security through the collection, analysis, and dissemination of financial intelligence to the regulatory authorities.







