Why Should You Attend:
Designing an effective Standard Operating Procedure (SOP) and Standard Test Method (STM) is the pre-requisite to complying with the regulations guiding the manufacturing and testing of products. FDA inspectional form 483 inspectional findings relates to inadequate personnel training as well as personnel not following written SOPs/STMs. Poorly written and planned standard operating procedures (SOP) and Test Methods containing vague, incomplete or ineffective instructions is open to incorrect interpretations by personnel. There have been conflicts between written procedures when compared with internal and external policies and regulations due to poor or inadequate planning of the process for writing SOPs and STMs. Organizational and management issues relating to document review, verification, approval and training of personnel has led to issues affecting the manufacture of products. The non-involvement of other impacted departments during the planning, review, processing and approval of the SOP or STM creates costly mistakes to manufacturers of drug products. Understanding how to design, develop, process, review and apply the use of a well written SOP or STM will reduce the number of deviations, false out of specification results, failure investigations and non-conformances associated with the manufacture of products.
This 90-minute training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.
The attendee will gain a better understanding of the sequence of designing, development, drafting, processing and approval of an effective and compliant SOP or STM. The industry applications, regulations, content, organization, development, management process/cycle, content and formatting of an SOP and STM will be discussed.
Understanding these requirements will aid in the reduction of manufacturing and testing errors arising from an unclear, poorly planned/executed and vague procedures that are left to several varying interpretations and applications which may sometimes lead to non-compliance.
This webinar will provide the attendee the ability to:
Areas Covered in the Webinar:
Who Will Benefit:
This webinar will provide a great resource to Pharmaceutical, Biotechnology, Biologics, Drugs, Medical Device, In-vitro Diagnostics Industry personnel within the following functions:
Charity Ogunsanya has more than 23 years of extensive experience within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic processing, Quality Control Subject Matter Expert (SME) for multiple fortune 100 companies. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and is currently in the Advanced Academic Master’s Biotechnology Program at the Johns Hopkins University with concentration in Biotechnology/Biodefense. She is the CEO/Owner of her consulting firm named Pharmabiodevice Consulting LLC. Her consultancy provides support to Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries.
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).
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