Best Practices for Implementing an Effective Cleaning Validation (using principles of upcoming ASTM E3106)
This webinar discusses the implementation of Cleaning Validation programs based on global Cleaning Validation Guidelines as they are currently available for pharmaceutical and biopharmaceutical industries. What makes this webinar special and unique is a very rare glimpse into upcoming ASTM E3106 for Cleaning Validation. This is a Risk-Based Science-Based Lifecycle approach guidance document that was fully v..
One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, a release of the sub-standard product, or product recall. Furthermore, costly and time-consum..
Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you prepare for and manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your qu..
Unfortunately, being good at your job doesn’t guarantee that you will be a good leader or manager. Yes, you were good enough to get promoted but being a manager has challenges you never dealt with when you were an employee. The transition to management isn’t just a promotion and a pay raise—it’s a shift into a new type of role that requires new skill sets and you are bound to trip up along the way when you ..
The Millennial generation is a force to be reckoned with. They are talented, innovative, entrepreneurial, and creative. They are also highly mobile and prone to job-hopping. Retaining top talent is a key business imperative and old strategies are no longer effective.More than 60% of Millennials leave their company in less than three years and their turnover is greater than any other generation. In addition,..
Best Practices for Using Your Quality Management System’s Quality Objectives and KPIs for Meaningful Process Improvement
Numbers, data, facts, perfect information all allow us to make more informed less risky decisions in every aspect of our lives. Due to the increased demands and business pressures to do more with fewer resources, decision-makers in every organization are tasked with making fast and informed decisions.Knowing how what to measure, how to measure it, what the data says where you are now, where you want to be i..
1. This is a Business Relationship a. You are representing your Company or Agency b. You’re First Priority should be to look out for the best interests of your Employer c. Your Vendor will be looking out for their best interests d. Avoid getting into a personal relationship with your supplier or their representative2. Coming to Terms with your vendor a. Make..
This webinar will highlight several best practices in the hiring lifecycle from finding great candidates to converting the best of them into new members of your team and getting them up to speed as quickly as possible.It will include proven approaches in the following areasWhere to find candidates, both through paid and free sources, how to screen candidatesHow to screen candidates, through their resumes, L..
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it ..
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more ..
This webinar examines the scope and nature of employee dishonesty and explains the risks to employers and organizations of all types. It goes on to deal with the practical aspects of prevention and response to victimization, as well as balancing the need to assure that corrective and deterrent programs and policies do not unduly interfere with normal operations and opportunities and do not generate other ma..
Learn to identify and apply differing and conflicting rules with respect to the specific health care practitioner, the specific health care facility practice, and the emerging rules and regulations for electronic medical records confidentiality, security, and disposition. In addition to these clinical requirements of a specific profession, additional state laws set forth the content and retention of other t..
Whatever you call those extra assignments or even your larger "regular" work responsibilities, learn to apply project management tools and approaches to get better outcomes when facing barriers to completing work successfully. Identify the business problem you are solving to keep your work focused, efficient, and moving toward the desired solution. Expand your standard responses to barriers to include more ..
This webinar will highlight difficulties in obtaining relevant and useful dissolution results based on current practices. This will be followed by the description of principles of drug dissolution testing leading to a simple and common set of experimental conditions reflecting a bio-relevant method. The discussion will be presented describing that the suggested bio-relevant method would become a QC method a..
The blockchain is a new fundamental technology. It has been liking to the advent of the internet in the scope of its possible changes for the future of the business world. This technology has a chance to change everything throughout the business. Most people are clueless about blockchain and they don't fully understand it. Even if you try to Google blockchain, read about it and its implications it becomes c..