Current Regulatory Requirements for Sterile Products
- Speaker:Kenneth Christie
- Product Code:GRC-90455
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This course will focus on current validation requirements for the manufacture of sterile products and the key areas of importance and audit focus. The instructor will suggest several industry best practices and review a checklist of process and procedures to ensure compliance to current requirements.
This webinar will highlight and summarize the following main components relating to current validation requirements for sterile products:
- Review of current regulations and guidance documents
- Typical expectations when aseptic processing is involved
- Expectations for protocols used to document the qualification of associated equipment, utilities and processes
- Recently cited regulatory deficiencies
It will provide a template of things to ensure in accordance with the stipulated guidance and regulations to help assure sterility and stay compliant.
The regulatory requirements for sterile products are found in a ‘Guidance for Industry’ document that was published in 2004. In addition, there are requirements found in 21 CFR 210-211 and 820. In all of these documents, the areas of importance and audit focus are:
- Equipment, utility and facility qualifications
- Validation of all sterilization processes
- Control of the environment and potential sources of contamination
- Personnel training and gowning requirements based on defined areas of cleanliness
- Laboratory controls, and
- Process simulations designed to verify the acceptability of the manufacturing process and operator activities
This course will review these key areas of importance that apply to sterile products in order to help attendees evaluate their own processes and procedures. Recent 483 observations will also be reviewed to help highlight common industry deficiencies and as a reference to compare attendees’ current practices.
- Review the current regulatory requirements and guidance documents dealing with sterile products
- Review the expectations for aseptically produced products
- Discuss the six quality systems that are reviewed during regulatory inspections
- Review common deficiencies cited with the manufacture of sterile drugs
- Review the importance of personnel training and control of microbiological contamination
Who can Attend:
- Quality Assurance
- Quality Control
- Laboratory Personnel
- Equipment Vendors
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the chief operating officer for VTS Consultants, Inc., located in Amhesrt, MA. His responsibilities specifically include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. He also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.
Mr. Christie was the validation manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.
Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, he serves as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
Mr. Christie has a BS degree in biology from Shippensburg State University (PA) and an executive MBA degree from Michigan State.