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CMO Supplier Quality Agreements - How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:EU GMP Chapter 7 "Outsourced Activities" January 2013Guidance for Industry -..
Coaching as a Leadership Skill
The acronym GROWER stands for Goal, Reality, Options, Will, Experiences, and Results. It provides a relatively simple framework for structuring a coaching session and has been adopted by many of the world’s major organizations. In many places, there is confusion about what coaching for managers and leaders really is, especially when compared to counseling, mentoring, advising, etc.In addition, the unfortuna..
Cold Calling Strategies, Tactics and Techniques
Building your cold calling skills will enable you to:Gain an advantage over the competition.Find new business opportunities.Become an indispensable employee who gets new business.Compete with existing vendors for lucrative customers.Establish rewarding relationships and gain respect.Become an entrepreneur.Cold calling ability allows you to determine and take control of your own future.You may have been told..
Collaborative Conversations, Building Trusting Relationships, and Increasing Engagement and Performance
Building trust and strong cohesive relationships in the workplace is critical for a number of reasons. Organizations that have a high level of trust in the workplace have higher productivity, greater engagement, and retention of staff.Trust is an essential element in team building, as it results in a sense of safety and security among employees. Employees who trust each other, as well as their leaders, crea..
Comparability Protocols for approved drugs
This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable the completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure which can be designed to save time and money in the future.Learning ObjectivesA..
Competency Based Human Resource Management
A job description literally describes a job, but a competency model describes the human being who does the job adequately or superlatively. This webinar explains the difference between a competency-based HR system and a job-description-based HR system. It defines competencies, explains the business reasons to use them, explains how competency models are developed, and reviews each component of HR when it is..
Complaint Handling and Adverse Event Reporting, CAPA, Recalls, and Product Life Cycle Management
Complaint handling is essentially the beginning of the process if not one crucial aspect of the process of collecting data concerning the product that is in the marketplace. It is your first “tip-off” that something might not be going as intended. Complaints are ignored at your peril and ignoring them results in a significant risk to the organization and to the patients that use your products.Complaint hand..
Complaint Management: Best Practices to Assure Compliance and Customer Retention
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved i..
Completing and Correcting Form I-9 to Ensure Compliance
Form I-9 is required to be completed by all United States employers. It is used to confirm that the new hire is eligible to work in the U.S. The US Immigration and Customs Enforcement Agency (ICE) requires that Form I-9 be completed accurately. Any inaccuracies, even including cross-outs, white-outs, missing information, and more, can result in substantial financial or even criminal penalties for employers...
Compliance Measures for Case Management Professionals
As case managers, we must be aware of the myriad of compliance issues that we must adhere to in our daily practice. Never has this been more important to our work as case managers then it is now. Our ability to remain compliant has become an element of audits from accrediting bodies such as the Joint Commission as well as the Centers for Medicare and Medicaid Services (CMS). It is the right thing to do for ..
Compliance Measures for Case Management Professionals in the Acute Care Setting
This program will review the compliance issues that most greatly impact your practice as a case management professional such as the 2-midnight rule, the NOTICE Act, HINNs, The Important Message, and others. Do you have a utilization review committee and is it compliant with the Conditions of Participation for Utilization Review? Are you compliant with the Federal rules for discharge planning? Case managemen..
Compliance with the OSHA Bloodborne Pathogens Standard in Healthcare Settings
Healthcare facilities struggle with compliance for the OSHA Bloodborne Pathogens Standard, especially with the newer requirements from the Needlestick Safety and Prevention Act. This session will be delivered by a former OSHA National Bloodborne Pathogens Coordinator and will give you first-hand experience regarding some of the mistakes that healthcare facilities make that result in citations and fines. It ..
Complying With U.S. Customs Laws
Participants will learn the basics of U.S. Customs laws and how to develop a Customs compliance program at their company. Participants will learn and apply the mechanics of classification of how to classify their products.The program will discuss all the key elements of a solid import program. The participants should be able to return to their office and enhance their import compliance program or develop an..
Comprehensive of Costing Best Practices
Whether a public company, private enterprise, or a not-for-profit organization, cost accounting is vitally important to any entity that offers products or services. Costing systems and policies are used as management tools for a variety of purposes including identifying cost and income structures for separate products/services and as an input to pricing evaluations. Increasingly they are used as a regulator..
Conducting HR Audits
The threats and risks from human resource management issues are increasing. No longer measured in only fines, penalties, and awards for non-compliance, human resource management affects keys business metrics, including the organization’s valuation and credit rating. Further, improper human resource management can significantly reduce managerial prerogatives, and seriously damage the organization’s reputatio..