The FDA Group's CEO, Nick Capman, sits down with Jonathan Wacks to discuss ways to minimize the stress associated with FDA inspections.
Jonathan is an experienced healthcare industry executive with a proven track record in startups and Fortune 500 companies. He has a strong background in international QA/RA, engineering, and project management, specifically with medical devices, electronic assemblies, and supply chain management.
Discussion points include:
» The importance of a robust QMS and the role of third-party audits in ensuring unbiased compliance assessments, and preemptively identifying compliance issues, underlining the need for thorough and honest internal evaluations.
» The need for leadership teams to understand audit findings in depth and use them to enhance internal processes.
» The importance of having well-calibrated and maintained test equipment, alongside well-crafted SOPs and trained personnel.
» The need for independent reviews of batch records, focusing on the clarity of lot status and data integrity.
» The need for regular reviews and updates of QMS processes, especially validation and verification procedures.
» The importance of re-evaluating product and process validation, including considerations for stability data, human factors, and the impact of significant changes.
» The critical role of software validation in the QMS.
» How to effectively handle questions from FDA investigators and the importance of clear, honest communication during audits.
Jonathan is a medical device and pharmaceutical Consultant specializing in QA/RA and Product/Process Control. His services include M&A due diligence support, conducting site quality and regulatory compliance audits, and leading employee training programs focused on FDA QSR/cGMP and validation.
He also works in project management and operations improvement, particularly in research use diagnostics and API manufacturing. He's a regular and highly-valued contributor to our Insider Newsletter.
Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/
Navigating FDA Regulations for SaMD AI and Machine Learning with Adam Foresman
Crafting Quality Systems for Each Phase of Drug Development with Carlos Yuraszeck
Leading Through Transition: Strategic Insights from Novartis's Front Lines
Real Talk on Remote Leadership with Nick Klingensmith
Audit and FDA Inspection Readiness Best Practices with Divya Gowdar
Mastering the TMF: Ensuring GCP Compliance and Inspection Readiness with Donna Dorozinsky
The Startup's Guide to Setting Up Cell Therapy Manufacturing: Navigating Regulations, Resources and Timelines
A Blueprint for Quality Culture with Vincent Cafiso
Clinical Data Standards in Focus: SDTM Compliance with Sunil Gupta
The Link Between Quality Culture and QA Communication Pathways with David Marks
Mastering Medical Device Supplier Management with Paul Hakamaki
Recent FDA Enforcement Trends with George Toscano
Growing Your Career in RA/QA with Jessica Smith Beaver, PhD
Drug Delivery System Innovation and Leadership with Steve Knowles
Motivating Technical Teams in the Life Sciences: A Conversation with Rick Beatty
Cross-Cultural Pharma: Mike Martin's Experiences from Puerto Rico to China
Courageous Leadership to Reinvent Our Healthcare System
The Critical Role of 'Hyper-Targeting' in Rare Disease Drug Development
A Journey into Life Sciences Investment: Strategies, Challenges, and Opportunities with Sal Buscemi
Create your
podcast in
minutes
It is Free
DNA Today: A Genetics Podcast
Short Wave
Unexplainable
Stuff To Blow Your Mind
Ground Truths