Practical Aspects of Aseptic Processing
Instructor:
Frank Settineri
Product ID: 701139
Training Level: Intermediate to Advanced
- Duration: 90 Min
Why Should You Attend:
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
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.
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Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
