Why Should You Attend:
FDA inspection / audits are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, food and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.
This course will examine the fundamental requirements for all systems subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. This webinar will discuss details of Auditing of Systems : Quality, Facilities and Equipment, Materials, Production, Packaging/Labeling, Laboratory Controls.
In addition, this course will include a list of relevant regulations and guidelines and demonstrate how to monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs).
Areas Covered in the Webinar:
Who Will Benefit:
T. Rama Rao is an M.Pharm (Pharmaceutical Technology)-in the year 1985, from Department of Pharmaceutical Sciences, Andhra University, in Visakhapatnam, India. He was awarded G.P.Nair Gold Medal by Indian Drug Manufacturers association (IDMA), Mumbai & Nageswara Rao Pantulu Gold Medal by Andhra University for standing first In B.Pharm 1983.
He has over a period of 30 years of experience, having worked in medium and large scale organizations like Ranbaxy, Hoechst Marion Roussel Ltd, Biological E Ltd, Procter & Gamble Hygiene and Health Care Ltd ( operated by SRL) etc. He has discharged at executive as well as leadership responsibilities in the areas of design & development, manufacturing, qualification & validation, manufacturing, operations management, quality assurance, quality management, audits & compliance, regulatory affairs, technology transfer, project management, R&D formulations and operational excellence .He led team of experts in preparing the regulatory filings, facing GMP inspections / audits and responding to the inspectional observations of various regulatory agencies, such as WHO, ISO, USFDA, UK-MHRA, etc.
He is an active member of professional associations like Indian Pharmaceutical association (IPA) .He is a technical Consultant for Andhra Pradesh Meditech Zone Ltd (AMTZ), Visakhapatnam. He was as a Consultant for Drug & Laboratory (PMU) for Central Drug Standards Control Organization (CDSCO) Delhi under Ministry of Health and Family Welfare (MoHFW) GOI, New Delhi. He is a regular speaker in industry & academia seminars/ conferences and a trainer on the topics like qualification and validation, process validation, quality systems. Industrial pharmacy etc.
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.If you have any concern about the content of the webinar and not satisfied 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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