Why Should You Attend: Compliance with compendial standards for residual solvents is required for all drug products provided in the United States, and similar requirements exist in all the major markets of the world. Since every product is unique, and since the requirements refer to over 50 different solvents, achieving compliance can be very challenging. Many, many firms have received incomplete or warning letters from the FDA as a result of failure to adequately address the reporting of residual solvents.
This course is designed to provide participants with practical strategies for complying with regulatory requirements for residual solvents while minimizing resource requirements. The course will address FDA expectations, understanding the potential sources of residual solvents in drug products, appropriate analytical methodology and strategies for characterizing solvents in components and in drug product. The course will address reporting levels of residual solvents, and conclude with an opportunity for questions and answers.
At the end of this training you will be armed with an understanding of the expectations and approaches which have been successfully accepted by regulatory agencies, you can anticipate success in meeting the compliance requirements while significantly reducing the resources necessary to comply, when compared with a straightforward application of the compendial requirements.
Areas Covered in the seminar:
Learning objectives:
- Upon completion of this course the learner should be able to:
- Understand the requirements for residual solvents in the US, EU and Japan.
- Identify the classes of solvents and address sources of solvents.
- Effectively utilize options for describing Class 2 solvents.
- Select appropriate analytical procedures.
- Utilize strategies to minimize the testing and resources required to meet the requirements.
- Report levels of residual solvents appropriately
Who Will Benefit:
This webinar will provide valuable assistance to all drug companies/ manufacturing sites.Those that would benefit most would be:
- Chemists (Research, Quality Control, CRO) involved with residual solvents testing and their managers,
- Regulatory affairs/CMC personnel responsible for documenting compliance with residual solvents requirements
- Laboratory managers and staff
- Analysts
- QA/QCU managers and personnel
- Training department
- Documentation department
- Consultants
