The Challenges of Virtual Audits...The Developing New Norm
Mr. 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, biotechnology, and cosmetics industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie also performs vendor/supplier audits (GXP, GLP, GCP), site pre-approval inspections and assists clients with addressing and correcting regulatory observations. He possesses extensive knowledge of regulations covering 21 CFR Parts 210-211, 11, and 820: ISO.
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, Health Canada, 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, Mr. Christie
served as a member of the ISPE’s Professional Certification (PCC)
Commission as an Examination Development Committee (EDC) member.
The Quality System Requirements are clear in the expectations for the qualification of our vendors and suppliers required for the products made. Considering the global pandemic, worldwide travel bans, and social distancing, the performance of on-site audits has fallen by the wayside, forcing everyone to establish “virtual” audits. The approach is challenging to the auditor as well as the auditee. This webinar will provide those in attendance the opportunity to ask questions, whether new at auditing or those trying to maintain their program. The success of virtual audits requires planning and familiarity with the technology used. Companies must also have back-up plans if technical problems occur and they will!
Prior to conducting such audits, expectations may also have to be changed and the acceptance of the overall process evaluated upon its completion. The inability to closely look at equipment or operator technique needs to be evaluated by the auditee who has the responsibility of how best to handle anticipated questions. A typical time-saver is to secure documents prior to the audit and perform their reviews when not under the timelines allotted during the audit. This allows for focused questions and permits more information to be reviewed.
Regulatory requirements for supplier audits.
- Items to prepare for the first time and follow-up virtual audit
- Impact to documents such as quality agreements
- Points to consider for both the auditor and auditee
- Technologies available to perform virtual reviews and address concerns
- Follow up questions & answers period
Course Level - Basic
Who Should Attend
- Quality Assurance and Quality Control
- Third-Party Customers
Why Should You Attend
The need to continue to audit critical suppliers did not stop with the pandemic we all are facing. It has created companies to be more adaptable to continue to meet the quality system requirements, as it applies to the supplier management program, and corporate expectations. Converting to virtual audits requires both parties to adjust their expectations and methods by which the audit will be performed. Anticipating technical glitches can save both parties from losing valuable time and help assure all topics are adequately covered to make an informed decision as to the acceptability of the supplier.