This FDA compliance training will describe the essential requirements for producing sterile products in a practical, clear, concise manner that will facilitate its implementation.
The FDA Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing, is the latest document that provides directions for manufacturing, controlling, testing and releasing sterile products that are compliant with cGMPs. Since it is a comprehensive document that covers the requirements needed to produce sterile products it can be overwhelming to comprehend and incorporate.
Areas Covered in the seminar:
- Overview of the FDA Guidance document Sterile Drug Products Produced by Aseptic Processing including associated cGMPs.
- Training - the most important component.
- Buildings and Facilities.
- Components and Container Closure.
- Validation and Sterilization.
- Laboratory Controls.
- Blow Fill Seal Technology.
- Documentation
Who will benefit:
This webinar will provide an overview of the requirements necessary for manufacturing aseptic products. Employees who can benefit include:
- Senior Management responsible for making final decisions
- Manufacturing personnel
- Quality Assurrance and Quality Systems directors, managers and auditors
- Laboratory Managers, supervisors, analysts and technicians
- Regulatory and Compliance Management
- Consultants
Instructor Profile:
Frank Settineri, is the founder and President of Veracorp LLC, a consulting firm that specializes in providing pharmaceutical, biotech, medical device and startup companies with the essential advice they need to keep their business running efficiently and within regulatory guidelines. With over 30 years of pharmaceutical business, manufacturing and laboratory experience he is an authority on FDA Warning Letters and 483s, GMP compliance, validation planning, outsourcing, microbiology, sterile and non-sterile manufacturing issues. His accomplishments in science (setting up and running laboratories), compliance (auditing, validation, and outsourcing) and business (building a start-up pharmaceutical company and its infrastructure) endow him with a unique oversight of the industry that has benefited his clients, including major pharmaceuticals, start ups, laboratories and generic companies.
