Process Validation; The Impact Of FDA And ICH Guidances
In 2011, the FDA issued its Guidance for Industry, Process Validation: General Principles and Practices. This guidance integrates quality system concepts from ICH Q8, ICH Q9 and ICH Q10 including lifecycle and identifies the three stages of the process validation lifecycle. The Europeans followed with a similar guidance for process validation including the lifecycle concept. This has now been incorporated i..
Laboratory Safety Culture
Managing your lab safety program is a job that never stops, but how you approach the various tasks has to change in order to prevent “safety stagnation.” Learn tips and tricks for spicing up your safety training and to make the material you’re giving stick so that your lab safety culture continues to thrive. Hear safety stories and ideas to help you achieve the safety compliance you desire.Areas Covered &nb..
Managing Risks of B2B Payments
Business to Business (B2B) arrangements are unique and governed by different Rules and laws than consumer payments. As such, a business originating or receiving business ACH payments can put themselves in a position of undue risk of loss if they don’t manage these payments appropriately. In this session, we’ll explore these payments from both an origination perspective (i.e. your business is sending payment..
Managing the Brouhaha of Chaos in Your Workplace: Solutions For Surviving the New Workplace Norm
Is your inbox overflowing with e-mails requiring your immediate attention? Are you frazzled because of the time frame required to finish a project? Are you fed up with the copier always breaking down just when you are the one who needs it? Do you have too many direct reports to support? Do you have to report to more than one boss? Do any of these issues sound familiar? Let’s face it, chaos is the new norm f..
CGMP Preparation for Phase 3 and Commercial Manufacturing
This session with exploring the elements required for a successful transition from an early phase development organization to a “Commercial ready” manufacturer. It is intended for anyone who may be involved in the oversite and participation in the manufacturing and distribution of a potential commercial product. Upon completion of this session, the attendee will have a greater understanding of the process a..
Creating a Cyber Incident Response Program That Works
The best way forward is an efficient Incident Response Program that allows an organization to respond with speed and agility while empowering businesses to maintain continuous operations. Such a solution also reduces revenue loss, reduces fines and lawsuits and protects brand reputation.Information Security, Governance & Risk, are all critical aspects of the planning and execution of the Information Sec..
Using and Applying Conditional Formatting and Data Validation
With Conditional Formatting, we’ll show you how massive amounts of data can be analyzed to visually emphasize relationships, find exceptions, and spot trends.Conditional formatting can change the format of cells based on their values in multiple ways including font style, underline style, font color and fill color and more. Adding your own formula to a conditional formatting rule gives it a power boost to h..
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2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..
Build The Right Type Of Pay Ranges For Your Employees
Many companies are under pressure to increase pay levels at the lowest levels in the organization. Activists and politicians alike are encouraging companies to take action. Recently in the news, we saw Amazon make the move by increasing the minimum wage to $15 per hour for its US employees. How can smaller companies compete without sacrificing profitability?The answer is found in the balance bet..
Mexico Import Process Basics
Non-tariff measures (barriers) are generally defined as policy measures other than ordinary customs tariffs that can potentially have an economic effect on international trade in goods, changing quantities traded, or prices or both (UNCTAD).Areas Covered Non-Tariff Barriers definition and objectiveDifference between a Direct and an Indirect NTBDirect NTB’s established by the Mexican ..
Process Reliability Modeling: Determine The Cost Of Ineffective Process Management
Ineffective process management will result in a significant loss to organizations bottom line. The amount of loss depends upon your organizations Sigma Score, for example, a Sigma Score of 3 suggests a loss of 25% to 40% of sales (Sigma Scores vary from 2 to 6). A score of 6 suggests less than 1% of sales dollars are lost.Areas CoveredCost Justification: What is Your Organization’s Sigma Level Improvement T..
The Do’s and Don’ts Of Terminating Older Workers
When the calendar turned to January 1, 2011, the first wave of “baby boomers” turned 65 years old. This is normal retirement age. Today due to the nature of the economy they are not retiring. More and more want or need to stay in the workforce. Ten thousand baby boomers will turn age 65 every day for the next 17 years. Even with the desire to stay at work so strong, baby boomers are exiting the workforce in..
Current Issues In Credit Risk
The reactions to the 2007 crisis have amply shown that, for most people who had to react as regulators, lenders or investors, the body of crisis-fighting knowledge was picked up essentially from the last 10 years. Few people referred to the main precedent, the 1929 crisis, to pick up wisdom from precedents: it was deemed too old to be relevant. Regulators’ reactions indicated that little was done to envisio..
Risk Evaluation and Mitigation Strategies
Pharmaceutical and biologic products often have adverse effects (AE) that may not be identified until after approval and release. AE can be observed either in general or in specific patient populations whether the patient is at home or in a hospital or other care facility. AE may be related to class and structure. These events may also occur due to interactions with other pharmaceutical compounds the patien..
Solving The Employee Training, Motivation and Retention Challenge
Current and future labor shortage will continue to drag down your company’s growth, performance, and profitability. What do great managers know that average managers do not when it comes to employee training, retention, and motivation? Experience has shown that implementing a solid employee development process, which includes industry best practices, can drive productivity up by almost 40%, at little cost. ..