|
Overview: This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, efficacy and/or data integrity. Key components of documentation and record management system will be introduced. Regulatory requirements will also be discussed as the basis of documentation standards. It will also cover different types of records and how it would affect quality systems. Why should you attend: SOPs are important in pharmaceutical industry. Most of 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 systems for SOPs used in GMP operations. This 2-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, you will be able to understand the critical role SOPs play in daily operation, strengthen and maintain your current SOP system and organize effective training for SOPs.This course is filled within interactive exercise to help participants develop practical understanding of this important tasks and a logical approach to develop their own SOP system. Areas Covered in the Session: FDA requirements and Expectations Documents including SOPs General controls for Documentation Determine the needs of new SOP Determine the responsibility for SOP Different types of SOPs Format and writing techniques for an SOP Organizing information on an SOP Management Aspects of SOP Course Outline: Day One: 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 Two 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 Who Will Benefit: Laboratory Analysts Quality Assurance scientists QA/QC Mnalysts QA/QC Managers Auditors Inspectors Pharmaceutical Development and Manufacturing Personnel Manufacturers of Raw Materials and Excipients Contract Laboratory Organization Personnel About Speaker – Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik (www.pharmalytik.com), where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA's Consent Decree. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), US Pharmacopeia (USP), Pittsburgh Conference, 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. Date, Venue & Price: Location: Los Angeles, CA 13th & 14th March 2014 9 AM to 6 PM PDT Venue WILL BE ANNOUNCED SOON Price: $1,295.00 Register now and save $200. (Early Bird) Until January 31, Early Bird Price: $1,295.00 From February 01 to March 11, Regular Price: $1,495.00 Location: Philadelphia, PA 17th & 18th April 2014 9 AM to 6 PM EDT Venue : DoubleTree by Hilton Hotel Philadelphia Center City Price: $1,295.00 Register now and save $200. (Early Bird) Until March 10, Early Bird Price: $1,295.00 From March 11 to April 15, Regular Price: $1,495.00 Address: 237 South Broad Street, Philadelphia, Pennsylvania, 19107-5686, USA Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com Event Link: http://bit.ly/1eWX2lm LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.php GlobalCompliancePanel NetZealous LLC 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Related Articles -
Writing and Managing SOPs, Compliance Training, GMP Training, Regulatory Compliance, SOPs Training, USA Conferences, USA Seminars, Los Angeles Confere,
| 
