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Summary: GlobalCompliancePanel to hold RAPS-approved, two-day, in-person seminar in Los Angeles, CA on the topic, “The A to Z's of Writing and Enforcing Effective SOPs (Standard Operating Procedures)” on March 13 and 14, 2014 (Thursday & Friday). Kim Huynh-Ba, Executive Director of Pharmalytik, will be the speaker at this two-day session. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Venue, date and timings: The venue for this seminar, which will be held in Los Angeles on March 13 and 14, 2014, from 9 A.M to 6 P.M EST, will be announced soon. What the seminar is about: SOPs are critical to the pharmaceutical industry. This is attested by the fact that most Good Manufacturing Practices (GMP) violations are due to inadequate SOPs or SOPs that are not well written. Any critical GMP activities that affect quality and safety of the drug products will require written procedures. This course will provide participants with tools to write effective SOPs. This course will also discuss the regulatory requirements of documentation and Record Management System (RMS) for SOPs used in GMP operations. This session will discuss key considerations for Good Documentation Practices (GDP) that would impact product quality, safety, efficacy and/or data integrity. It will introduce key components of documentation and RMS. The role of regulatory requirements as the foundation of documentation standards will also be explained. This seminar will also cover different types of records and how they would affect quality systems. This two-day course will emphasize practical issues such as the role of SOP in GMP operations, how to improve and maintain existing documentation system, and how to determine gaps or overlaps to strengthen the existing system. After this course, participants will be able to understand the critical role SOPs play in daily operation, will be in a position to strengthen and maintain their current SOP system, and can organize effective training for SOPs. This course is filled with interactive exercises to help participants develop not only a practical understanding of these important tasks, but also a logical approach to develop their own SOP system. The speaker will cover the following areas during this two-day session: o FDA requirements and Expectations o Documents including SOPs o General controls for Documentation o Determine the needs of new SOP o Determine the responsibility for SOP o Different types of SOPs o Format and writing techniques for an SOP o Organizing information on an SOP o Management Aspects of SOP About the Speaker: Kim Huynh-Ba is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices. She has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses. Kim is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President. She is the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of USP Impurities of Drug Products Expert Panel (2012-15). Kim is a recipient of the 2008 Service Award of Analysis and Pharmaceutical Quality Section and 2008 Recognition Award of Regulatory Section of AAPS. She also received the 2001 DuPont Pharmaceutical Company Asian American Leadership Award. The agenda: The seminar will have the following agenda: Day 1 –Agenda Lecture 1: FDA requirements and Expectations Lecture 2: Documents including SOPs Lecture 3: General controls for Documentation Lecture 4: Determine the needs of new SOP Lecture 5: Determine the responsibility for SOP Day 2 –Agenda Lecture 6: Different types of SOPs Lecture 7: Format and writing techniques for an SOP Lecture 8: Organizing information on an SOP Lecture 9: Management Aspects of SOP Lecture 10: Training for SOPs For whom: This seminar will benefit: a. Laboratory Analysts b. Quality Assurance scientists c. QA/QC Analysts d. QA/QC Managers e. Auditors f. Inspectors g. Pharmaceutical Development and Manufacturing Personnel h. Manufacturers of Raw Materials and Excipients i. Contract Laboratory Organization Personnel About GlobalCompliancePanel: GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and compliance-related services relating to Medical Devices, Pharmaceutical, FDA, Food, PCI industries, and SOX. Some of the Governing Areas its webinars cover are GxP (Manufacturing/Clinical/Lab), EU and ISO. These seminars are an extension of online trainings, at which GCP has conducted around 700 webinars since inception on a variety of topics for these industries /verticals. More than 30,000 professionals have benefited from these trainings. GlobalCompliancePanel’s trainings are focused, flexible and tailored to the client’s need. This is the next in a series of regulatory and compliance related seminars that GlobalCompliancePanel has been organizing all over the US. Its previous seminars have met with resounding success. GlobalCompliancePanel’s seminars have helped participants reach their career milestones. In bringing globally renowned experts in the field of regulatory compliance and executives in the industry together, GlobalCompliancePanel fosters a learning experience. With trainings that are focused and relevant, GlobalCompliancePanel seeks to serve as a bridge in the area of continuous professional education for regulatory and compliance-related fields. Price: Register now and save $200. (Early Bird) Until January 31, Early Bird Price: $1,295.00. From February 1 to March 11: Regular Price: $1,495.00 Discounts are available for group participation in the following manner: For two attendees: 10% discount For three to six attendees: 20% discount For seven to 10 attendees: 25% discount For more than 10 attendees: 30% discount To avail the above group discounts, all the participants should register by making a single payment. Please note that the registration will be closed two days (48 hours) prior to the start date of the seminar. Call our representative on 1800 447 9407 to have your seats confirmed. Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com LIVE CHAT SUPPORT- http://www.globalcompliancepanel.com/chat/client.php GlobalCompliancePanel NetZealous LLC, 161 Mission Falls Lane Suite 216, Fremont CA 94539
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