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Overview: This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, and 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 • Auditors • Inspectors • Pharmaceutical Development and Manufacturing Personnel • Manufacturers of Raw Materials and Excipients • Contract Laboratory Organization Personnel About Speaker: David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. DATE, VENUE & PRICE: Location: Singapore 3rd & 4th July 2014 9 AM to 6 PM Venue: Mandarin Orchard Singapore Venue Address: 333 Orchard Road, Singapore 238867 Price: $1,595.00 Register now and save $200. (Early Bird) Until May 10, Early Bird Price: $1,595.00 From May 11 to July 01, Regular Price: $1,795.00 Contact Information: Event Coordinator Toll free: 1800 447 9407 Call: +65 3158-1047 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php EVENT Link – http://bit.ly/1i7PG1N Net Zealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
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Regulatory Compliance, Federal Food, Cosmetic Act, medical device manufacturers, GMP operations, 510k device, FDA regulations, Effective Compliance,
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