SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions, including sales, marketing, manufacturing, quality, and regulatory affairs. An absence of and non-adherence to SOPs are often cited in reg..
This webinar will help Sponsors, CROs in the US, EU and internationally; understand how to write SOPs to comply with inspection requirements.The lack of or inadequate standard operating procedures (SOPs) continue to dominate the FDA's and other regulatory inspector’s inspection observations. This is often caused by poor writing and management and control of SOPs. SOPs need to be easily understood by all tho..
Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally, an auditor has personal experiences of what a state of control looks like and has visited sufficient places to know what to look for. Anyone in a medical device se..
Research indicates that most teams are afraid to engage in the conflict that is necessary for optimal success. In this webinar, I will discuss the reasons behind this phenomenon, how leaders can promote an environment where even the most introverted members will feel free to participate, and other ways to stimulate healthy debate, and I will explain how to manage conflict for the benefit of your team’s effe..
The role of corporate leadership in educating employees on risk management and resiliency is critical in ensuring fast and accurate communication and decision-making. Good decision making is critical for all organizations. Unfortunately, the nature of decision making is not generally well understood by the individuals making the decisions. This presentation explores the crisis management team (CMT) and the ..