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
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
Who Will Benefit:
• Laboratory Analysts
• Quality Assurance scientists
• QA/QC Analysts
• QA/QC Managers
• Pharmaceutical Development and Manufacturing Personnel
• Manufacturers of Raw Materials and Excipients
• Contract Laboratory Organization Personnel
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:
Held: 13th and 14th 2014, Los Angeles, CA
Venue: WILL BE ANNOUNCED SOON
Price: $1295.00 (Seminar for One Delegate)
Discount: 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
Get fabulous discounts by participating in groups of two or more.
Toll free: 1800 447 9407
Fax: 302 288 6884
Live Chat Support Also - http://www.globalcompliancepanel.com/chat/client.php
NetZealous LLC, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
For More Info Click Here: http://bit.ly/1dvLqaY