Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
The webinar begins with an introduction to the regulatory landscape governing contract manufacturing operations. The presenter, an industry expert with extensive knowledge of FDA and European regulatory guidelines, sets the stage by highlighting the importance of compliance and its impact on product quality, patient safety, and market access.
Moving forward, the webinar will dive into the FDA regulatory framework. Participants will gain a comprehensive understanding of Current Good Manufacturing Practices (cGMPs), facility registration, inspections, and documentation requirements.
Transitioning to the European regulatory environment, the presenter will delve into the guidelines set by the European Medicines Agency (EMA) and the Medical Device Regulation (MDR). Participants will learn about Good Manufacturing Practice (GMP) regulations, conformity assessments, and the significance of CE marking. Practical tips and insights will be shared to help participants navigate the unique compliance requirements specific to the European market.
The webinar's central focus will then shift to the CMO Supplier Agreement-a key component in ensuring regulatory compliance. The webinar will discuss the essential elements of the agreement, including quality standards, responsibilities, and procedures for manufacturing, quality control, and regulatory compliance. Participants will gain a comprehensive understanding of auditing processes, change control mechanisms, notification requirements, and intellectual property protection. Real-world examples of well-crafted CMO Supplier Agreements will be shared to provide practical guidance.
Why should you Attend:
Participants in this training will benefit by gaining a comprehensive understanding of the FDA and European regulatory guidelines for contract manufacturing operations in the pharmaceutical and medical device industries. By familiarizing themselves with these guidelines, participants will be equipped with the knowledge necessary to ensure compliance and maintain the highest standards of safety, quality, and regulatory adherence in their contract manufacturing relationships. They will also learn about the key considerations for a CMO Supplier Agreement, enabling them to establish effective processes for audits, change control, and intellectual property protection. Overall, this training will empower participants to navigate the complex regulatory landscape, mitigate risks, and foster successful and compliant contract manufacturing partnerships.
Areas Covered in the Session:
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