Effective Pharmaceutical GMP Audits and Self-Inspections

Date : 7th June 2018 to 7th June 2018

Place : United States, Aurora

Website :https://bit.ly/2Ii71v5

Contact Person:Training Doyens

Description:

OVERVIEW Regulators expect audits and self-inspections of the manufacturer to assure the quality of its own operations and those of its suppliers and contractors via repeated audits. FDA and other regulators have contributed to and endorsed ICH Q10, Pharmaceutical Quality System, which explicitly recommends audits as a key element in the review of process performance and product quality and also in the management of outsourced activities and purchased materials. WHY SHOULD YOU ATTEND Because of the extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal GMP audits in order to find and correct areas where the firm is not in full compliance with the GMP regulations before an FDA audit occurs. There are several problems with this approach, however. The auditors may not fully understand the regulations and may not have been trained in audit techniques. Another impediment is that an internal auditor is monitoring his/her friends. It is very difficult to point out errors committed by a friend since by calling attention to a lack of compliance may be interpreted as "telling on" the friend and possibly causing a problem for them. AREAS COVERED Principles and Audit Planning: • Planning and preparation • Audit types and techniques • Internal vs. external audits • The audit process Auditor Skills and Competencies: • What makes a good auditor • Managing audits Initiating, Preparing and Conducting the Audit: • Materials management • Documentation systems • Pharmaceutical quality systems LEARNING OBJECTIVES • Understand the GMP context for pharmaceutical quality system lead auditors • Plan, conduct, report and follow-up an audit of a GMP PQS • Provide guidance for auditors of suppliers, contractors, CMO service providers, outsourced activities and self-inspectors • Drive continuous improvement of systems and processes • Drive continuous improvement of auditors and audit systems WHO WILL BENEFIT This course is designed for auditors assessing: • Contract manufacturing organizations • API suppliers • Excipient suppliers • Packing component suppliers • Service providers For more detail please click on this below link: https://bit.ly/2jX19J9 Email: [email protected] Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882

Effective Pharmaceutical GMP Audits and Self-Inspections will be held in Aurora,United States on date 2018-06-07

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Deadline for abstracts/proposals : 7th June 2018

Keynote Speakers : Carl Pattersonis a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in theU.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.

Venue :Training Doyens, Aurora, CO, United States

Check the event website for more details.