Surprise FDA GMP inspection - how to prepare for it
Instructor:
Peter Calcott
Product ID: 701203
- Duration: 90 Min
Although unannounced GMP inspections happen when you least expect them, it is possible to predict when they occur. With this knowledge, you can predict when you must be ready. By examining the "hot topics" and your track record with the agency, you will be able to determine what the most likely areas to be covered are. This becomes the plan for gap analysis and checking on what you said you would do at the last inspection. The successful inspection is when you manage your agency’s expectations and then deliver on them. After the inspection, the responses are also very critical to prevent it from becoming a warning letter or even worse.
Areas Covered in the seminar:
- Can you prepare for an unannounced inspection? - yes
- when do you begin the preparation.
- what to expect from the inspection.
- what are the hot topics to focus on.
- How to determine your weak points.
- How to best train people for a routine GMP (Good Manufacturing Practice) inspection.
- Putting a strong repsonse to the observations in place.
- Following up on the commitments.
Who will benefit:
This webinar will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection. We will walk you through successful inspection strategies and logistics. After the inspection the putting together of a solid systemic CAPA is described and a process for tracking completion.
- QA and Complaince staff
- Senior management
- Manufacturing staff
- Validation
- Regualtory affairs staff
Peter Calcott, Ph.D.is the founder and president of Calcott Consulting, a consulting form focused on delivering solutions in supply chain, manufacturing, quality, clinical development and regulatory affairs for biologics and drug companies. He has presented at national meetings and is active in the biotechnology community vie BIO and the bay area BayBio trade associations where is chairman of the BIO RAC committee and a Board member of BayBio. He has over 30 years experience working at small start-up biotech as well as large Pharma companies in the areas of manufacturing, process science, and quality, clinical and regulatory affairs.
More Training By Experts
- Process Validation, planning, strategy, requirements, risk assessment, design description
- How to prepare for the unannounced FDA compliance inspection
- Quality by Design: what the FDA wants, what you must do, how you can deliver to their expectations and what relief you can expect
- Preparing for FDA Pre-Approval Inspections
- Clinical Trial auditing - Identifying risks and building a more compliant and successful trial
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
