This presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes. This webinar will be directed at workers with some experience who must now deal with the manufacturing of various biological products.
While biologics must follow the same GMP regulations as those that apply to small molecule drugs, there are additional GMP regulations that apply to biologics alone. The current transfer of 'specified biologics' to the Center for Drug Evaluation and Research (CDER) has created some confusion over their regulation. Gene and Cell Therapies have also created some confusion as well as new requirements that apply to these types of biologics. This presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes.
Manufacturing workers and supervisors who will produce biological products.
QA and QC workers who must develop testing and monitoring programs for biological products.
Regulatory affairs personnel who must prepare CMC sections and verify the compliance of their manufacturing operations.
Auditors who must review the activities of biological product producers.
Consultants
While biologics must follow the same GMP regulations as those that apply to small molecule drugs, there are additional GMP regulations that apply to biologics alone. The current transfer of 'specified biologics' to the Center for Drug Evaluation and Research (CDER) has created some confusion over their regulation. Gene and Cell Therapies have also created some confusion as well as new requirements that apply to these types of biologics. This presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes.
Areas Covered in the seminar:
- Definitions of types of biologics and the special classes of biologics.
- Regulations that apply to biologics in general.
- The situation with 'specified biologics.'
- Regulations that apply to gene and cell therapies.
- Changes in the emphasis of the GMPs when considering biologics.
Who Will Benefit:
This webinar will be directed at workers with some experience who must now deal with the manufacturing of various biological products. This is especially important for workers who must deal with different types of products while being employed at a single company.Manufacturing workers and supervisors who will produce biological products.
QA and QC workers who must develop testing and monitoring programs for biological products.
Regulatory affairs personnel who must prepare CMC sections and verify the compliance of their manufacturing operations.
Auditors who must review the activities of biological product producers.
Consultants
Course Provider
Steven S Kuwahara,
