ComplianceOnline

Good Manufacturing Practices and Audit Best Practices

Instructor: Rama Rao
Product ID: 705745
Training Level: Intermediate
  • Duration: 90 Min
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Read Frequently Asked Questions

This webinar will discuss the fundamentals requirements for system which gets audited during FDA inspection and how to conduct internal audit, report writing and audit follow ups.

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:

  • How will and Audits benefit an organization
  • Why is it important for an organization?
  • What are the best practices of GMP’s and audits.
  • Preparation for Audit
  • Conducting audit
  • Audit analysis
  • Audit report (internal Audit Report (First party), External (Second party) Audit Report Third party audit report)
  • Audit follow up

Who Will Benefit:

  • Senior directors
  • Managers
  • Supervisors
  • Quality Assurance
  • Quality Control
  • Research & Development
  • All those who have responsibility for ensuring operations and practices comply with current good manufacturing practices and good laboratory practices.
  • Production, Engineering, Warehouse, Procurement, Production Planning & Inventory Control, Supply Chain Management
Instructor Profile:
Rama Rao

Rama Rao
Founder and Senior Consultant, Sai Pharma Consultancy

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.

Follow us :
FDA's New Import Program for 2018 - Strict Precision

Refund Policy

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.

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