Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
This webinar will analyze each of these necessary elements of the batch record review process.
- Recognize regulatory requirements for batch records and batch record review
- Discover the essentials of batch record reviewer qualifications and training
- Establish a working relationship between production and quality reviewers
- What to do when a batch fails to meet specifications (discrepancies and deviations)
- Regulatory requirements for batch record review
- What to look for while reviewing batch records, i.e., good documentation practices, compliance to critical quality attributes and critical processing parameters
- Skills and responsibilities of an effective batch record reviewer
- Tools for effective batch record review
- Ensuring Production and Quality reviewers coincide with their reviews
- Extensive Training plan for batch record reviewers and when they can be considered “qualified” to review a record
- Quality Assurance batch record reviewers
- Production personnel and Production Managers who review batch record
|08:00 AM — 02:00 PM|
|No. of Days:||1|
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.
GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:
- Risk Management
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- Quality Management
Through the mediums by which we offer trainings, namely webinars, seminars, conferences and consulting, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.
Professionals who undergo trainings from GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. In the 10 years for which it has been in the professional trainings industry; GlobalCompliancePanel has developed a rich legacy of courses. It boasts an amazingly large repertoire of 5000 courses, which consist of over 2000 in-person seminars. ...