Professional Development Meeting:
Contract Service Provider Oversight
Speaker: Linda Sroka
Tuesday, April 29, 2014
Networking & Light Refreshments: 6:30pm
Presentation: 7:00pm
Location: Besso Room, on 4th Level adjacent to ice skating rink, Palisades Center, West Nyack, NY
About this topic:
Outsourcing manufacturing, packaging, and other contract services in the pharmaceutical industry has become a common industry strategy. As the global marketplace shrinks, more goods and services are sourced outside the company, and a robust quality management system must be established to assure the quality of goods and services is maintained. This presentation will challenge the widely used model of vendor qualification by an audit group as the primary or sole source of vendor oversight.
An interdisciplinary approach will include steps that can be taken to establish and maintain a cGMP supply chain with the use of contract service providers. Key aspects of a robust oversight program will include the roles and responsibilities of the business owner, legal and finance/purchasing departments as well as the quality and compliance units.
The business owner will have the primary responsibility for vendor management and oversight for day to day activities cGMP compliance while the quality unit is integral to supporting the business unit and providing guidance and oversight.
The quality management system will include policy, procedures, technical agreements, quality agreements, metrics, compliance audit program, change control and the monitoring of deviations and complaints to establish oversight of the services provided.
A close working relationship between the business and quality units with open lines of communication can lead to a effective contract service provider program both for the contract service provide and the contract service receiver.
About the Speaker
Linda Sroka has over 30 years in the pharmaceutical industry, having worked in manufacturing, QC-micro, and compliance and quality operations. She has over 20 years experience in conducting internal and contractor audits. She is currently employed by Celgene Corp. as a Senior Manager, Quality Compliance Management and in addition has a role as a Vendor Quality Manager. Linda has worked for such companies as Vineland Laboratories, Intervet, Ciba/ Novartis and Purdue Pharma.
Linda is a Senior Member of ASQ and holds certifications as a Quality Auditor, cGMP Pharmaceutical Professional and Manager of Quality/ Organizational Excellence. Linda has served on the ASQ Certified GMP Pharmaceutical Professional (CPGP) Exam Committee since 2008 and is the current CPGP Exam Chair. In addition, she also serves as a Member Leader of the Tappan Zee Section. On May 4, 2013 the Member Leader Excellence Award was conveyed to Linda at the 2013 World Conference on Quality and Improvement in Indianapolis, Indiana “in recognition of her exceptional and long term contributions to the Society at the local and national levels.”
Meeting is open to all
There is no cost for this event and preregistration is not required
Network with other Quality professionals from various industries
Obtain ASQ re-certification credit
Please post and invite your colleagues and friends to attend
this interesting and informative meeting
If you have any suggestions for future speakers or topics,
please contact the acting ASQTZ Programs Chair.
Tuesday, April 29, 2014
Networking & Light Refreshments: 6:30pm
Presentation: 7:00pm
Location: Besso Room, on 4th Level adjacent to ice skating rink, Palisades Center, West Nyack, NY
About this topic:
Outsourcing manufacturing, packaging, and other contract services in the pharmaceutical industry has become a common industry strategy. As the global marketplace shrinks, more goods and services are sourced outside the company, and a robust quality management system must be established to assure the quality of goods and services is maintained. This presentation will challenge the widely used model of vendor qualification by an audit group as the primary or sole source of vendor oversight.
An interdisciplinary approach will include steps that can be taken to establish and maintain a cGMP supply chain with the use of contract service providers. Key aspects of a robust oversight program will include the roles and responsibilities of the business owner, legal and finance/purchasing departments as well as the quality and compliance units.
The business owner will have the primary responsibility for vendor management and oversight for day to day activities cGMP compliance while the quality unit is integral to supporting the business unit and providing guidance and oversight.
The quality management system will include policy, procedures, technical agreements, quality agreements, metrics, compliance audit program, change control and the monitoring of deviations and complaints to establish oversight of the services provided.
A close working relationship between the business and quality units with open lines of communication can lead to a effective contract service provider program both for the contract service provide and the contract service receiver.
About the Speaker
Linda Sroka has over 30 years in the pharmaceutical industry, having worked in manufacturing, QC-micro, and compliance and quality operations. She has over 20 years experience in conducting internal and contractor audits. She is currently employed by Celgene Corp. as a Senior Manager, Quality Compliance Management and in addition has a role as a Vendor Quality Manager. Linda has worked for such companies as Vineland Laboratories, Intervet, Ciba/ Novartis and Purdue Pharma.
Linda is a Senior Member of ASQ and holds certifications as a Quality Auditor, cGMP Pharmaceutical Professional and Manager of Quality/ Organizational Excellence. Linda has served on the ASQ Certified GMP Pharmaceutical Professional (CPGP) Exam Committee since 2008 and is the current CPGP Exam Chair. In addition, she also serves as a Member Leader of the Tappan Zee Section. On May 4, 2013 the Member Leader Excellence Award was conveyed to Linda at the 2013 World Conference on Quality and Improvement in Indianapolis, Indiana “in recognition of her exceptional and long term contributions to the Society at the local and national levels.”
Meeting is open to all
There is no cost for this event and preregistration is not required
Network with other Quality professionals from various industries
Obtain ASQ re-certification credit
Please post and invite your colleagues and friends to attend
this interesting and informative meeting
If you have any suggestions for future speakers or topics,
please contact the acting ASQTZ Programs Chair.
