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Webinar Duration: 90 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Eyal Lerner
The quality requirements for Active Pharmaceutical Ingredient (API) will be reviewed in accordance to global API GMP- ICH Q7: “Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients” based on practical experience and other relevant guidelines. Requirements of FDA and EMA (US and EU) would be reviewed either. Start from starting materials, Active Pharmaceutical Ingredient and Advanced Starting Materials (ASM) their definitions and draw a line between them. We than cover the regulatory status and official requirements start with ICH Q7 and follows by the FDA and the European Medical Agency (EMA) regulations. Than will start to crack down each requirement with practical approach and interpretation.
The quality sections: Quality Management, Personnel, Buildings and Facilities – Containment, Process Equipment – Cleaning, Documentation and Records , Materials Management , Production and In-Process Controls, Packaging and Identification Labelling of API’s and Intermediates, Storage and Distribution, Laboratory Controls, Validation Change Control Rejection and Reuse of Materials, Complaints and Recalls, Contract Manufacturers (Including Laboratories), Agents, Brokers, Traders, Distributors, Repackers, and Relabellers Specific Guidance for API’s Manufactured By Cell Culture/Fermentation, API’s For Use in Clinical Trials
Would be discussed shortly as time permit, than some registration issues concerning filling, annual review and change report to file would be discussed. Especially the registration standard: Common Technical Document (CTD) according to ICH M4.
Why should you Attend: This webinar concern the basic requirements and fundamentals of API QS and therefore it is recommended for whoever engaged with activities in the development and manufacture of API: R&D, Regulatory Affairs, Quality Assurance and Quality Control which wish an in-depth background and understanding of API QS.
Areas Covered in the Session:
– Starting Materials, API and ASM – definitions and differences
– Regulatory overview
– ICH Q7
– FDA requirements
– EMA requirements
– APIC – GMPs for APIs: “How to do”
– Elements of QS:
– Quality management
– Buildings and facilities – containment
– Process equipment – cleaning
– Documentation and records
– Materials management
– Production and in-process controls
– packaging and identification labelling of API’s and intermediates
– Storage and distribution
– Laboratory controls
– Change control
– Rejection and reuse of materials
– Complaints and recalls
– Contract manufacturers (including laboratories)
– Agents, brokers, traders, distributors, repackers, and relabellers
– Specific guidance for API’s manufactured by cell culture/fermentation
– API’s for use in clinical trials
– Common Technical Document (CTD)
– ICH M4
– Q&A, Discussion
Who Will Benefit:
– API’s Quality Unit Staff (QA and QC)
– Production Managers
– RA Staff
– Suppliers Auditors
Eyal Lerner is owner of ELC Consulting Services which offers the pharmaceutical and medical devices industries support in all quality related issues: Preparation for inspections, CAPA and RCA, quality manual QSM, self-inspection (internal audits), compliance gap analysis, 3rd party audits (FDF and API’s), Management Review, GMP, GLP,MD: ISO 13485:2016 adjustments, DHF, DMR, V&V, 510k submission preparation and ISO 17025 (lab accreditation) and Validation. Eyal worked for the Israel National Accreditation Authority (ISRAC) as head of accreditation of chemistry and Biology and later on as audits director in Teva pharmaceuticals global quality unit. Eyal preformed more than 100 audits in various facilities around the world as a lead auditor and auditor.
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