FDAnews Announces — GAMP Classification for Pharma Equipment and Software Systems: Maximizing Utility, Minimizing Risk Webinar, Dec. 18, 2015

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With added emphasis on science based risk management and the reliance on technical experts to assist in the assessment process pharmaceutical manufacturing is becoming increasingly automated. With proper controls and oversight this can enable many life cycle and validation activities to be completed more efficiently while maintaining a high level of compliance.

GAMP Classification for Pharma Equipment and Software Systems:
Maximizing Utility, Minimizing Risk
Dec. 18, 2015 — 11:00 a.m. – 12:30 p.m. EST
http:// http://www.fdanews.com/gamp

With added emphasis on science based risk management and the reliance on technical experts to assist in the assessment process pharmaceutical manufacturing is becoming increasingly automated. That means Good Automated Manufacturing Practice (GAMP) is more relevant than ever. As the hardware and software evolves, GAMP evolves accordingly.

Generally, the more specialized the software, the greater the risk, particularly from user error. However, opportunities now exist to leverage contributions from suppliers and vendors in the implementation of regulated computer systems.

With proper controls and oversight this can enable many life cycle and validation activities to be completed more efficiently while maintaining a high level of compliance.

In this webnar, Mr. Gaurav Walia will walk attendees through the history of GAMP, including the transition to GAMP 5 and the changes in categorization. He’ll detail the top three challenges in implementing GAMP, the typical issues of legacy systems, key laboratory examples, and the top trends in consent decrees related to GAMP. He’ll conclude with a discussion of upcoming GAMP-related publications expected from the FDA and others.

At the conclusion of this webinar attendees will have the foundation for developing and establishing a compliant and effective computer system validation framework.

Meet the Presenter:
Mr. Gaurav Walia, M.S. has over 17 years of Pharmaceutical experience with careers at Monsanto/Searle, Pfizer/Oread, Forest Laboratories, and others while also serving as a Pharmaceutical Consultant in various disciplines from Quality Systems, R&D, CD, CSV, Vendor Certification etc. Mr. Walia has managed various technical, quality and compliance groups, such as but not limited to, Pharma R&D, Laboratory Information Management Systems (LIMS), Metrology, Quality Control (QC), Materials Import and Export, Safety, New Facility Design, Validation and Commissioning, Capital Budget (Instrument and Equipment Acquisition from R&D to Commercial, Operating Budget (All Service contracts), Regulatory Compliance, etc.

Who Will Benefit:

  •     Auditors
  •     Compliance officers
  •     Consultants/service providers
  •     Data management and statistics personnel
  •     Engineering and design controls teams
  •     Executive management
  •     General/corporate counsel
  •     Investigators
  •     Managers
  •     Manufacturing directors and supervisors
  •     Pharmaceutical and cGMP auditors
  •     QA/QC personnel
  •     R&D staff
  •     Risk management specialists
  •     Validation specialists, scientists, engineers

Webinar Details:
GAMP Classification for Pharma Equipment and Software Systems:
Maximizing Utility, Minimizing Risk
Dec. 18, 2015 — 11:00 a.m. – 12:30 p.m. EST
http:// http://www.fdanews.com/gamp    

Tuition:
$287 per site
Easy Ways to Register:
Online:    http:// http://www.fdanews.com/gamp    
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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