Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues
- Speaker:David R. Dills
- Product Code:GRC-90138
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Many FDA observations during GMP audits include issues that pertain to raw materials. Most warning letters sent by FDA to GMP plants will cite raw material management problems. FDA auditors pay a close eye to the ways that your raw materials are sourced, controlled, handled, accounted for and utilized at each facility. Raw material management is cited in many GMP regulations for all sorts of products regulated by FDA, including pharmaceuticals, biologics, medical devices, dietary supplements and diagnostic kits. Managing these materials can be difficult because many of them come from independent vendors that are not in your full control. Therefore, it is very important for manufacturers of raw materials to implement strong controls for managing risk with their raw materials. This session will provide an overview and snapshot of the requirements and expectations as set forth by FDA for industry regarding raw materials, extended supply chains, and the need to have tighter internal material controls with increased oversight and governance. Industry has seen significant problems of suppliers caused by weak or lack of oversight of such sources, including inadequate cGMP’s. This session will help you understand the current requirements for raw material management with tips for practical implementation. The Raw Materials qualification and control program is considered a key factor in assuring the quality of products, yet it is often deemed of secondary importance at a busy firm. Yet, supplier selection and qualification is equally important. It’s not just pharma and biologics related raw materials issues, materials failures can be caused by mistakes made at any point in the product development process for device manufacturers, including improper materials selection, reagent/raw material stability and manufacturing/process incompatibility issues as well. All manufacturers should view their suppliers both as partners and as extensions of their enterprise. This entails enforcing quality standards and conducting audits just as rigorously in the supply chain as in their own organization.
Areas covered in the session:
- What are the current FDA requirements for managing raw materials
- Tips on how to implement effective raw materials programs
- FDA expectations for GMP facilities for selecting raw material suppliers
- How to measure the quality of the materials while using integrated risk management principles and guidelines
- Common risk management practices for GMP facilities and impact on supplier and raw materials
- Qualify new RMs from new or existing suppliers by having well established and implemented procedures and systems
- Establish a robust and enforceable supplier selection and qualification program
- Product specific raw material issues
- Once the product design is finalized, implement a robust supplier management program to assure and control the quality of the raw ingredients
- Manage your raw materials as part of your quality management system
- FDA inspectional trends of raw material processes and supplier quality issues
Who will benefit:
This webinar will provide valuable assistance and guidance to medical device, pharmaceutical and other life sciences manufacturers responsible for the quality and security of their raw materials to support product development and product release activities. The employees who will benefit include:
All levels of management and departmental representatives
- Regulatory Affairs
- Quality Assurance/Quality Control
- Supplier Quality/Supplier Management
- Engineering/Technical Services/Operations
- Supply Chain Management
- QC and Analytical Methods Scientists and Technical personnel
- GMP site personnel
- Senior managers of companies using CMOs
David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, cosmetics and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits.
He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.
Mr. Dills has a strong background in the interpretation and applicability of FDA regulations, including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance requirements, GxP training, leads and directs activities for the registration and approval process and working with Agencies in Asia Pacific, EU and The Americas, including but not limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls; and strives for reduction of regulatory compliance risk for companies.
Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.