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Computer System Validation - Reduce Costs and Avoid 483s
Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs ...
Recordkeeping and Documentation in a GLP Laboratory (US FDA, US EPA and ...
IEC 60601-1 (3.1) The New Paradigm for Medical Device Safety
The Veterinary Drug Approval Process and FDA Regulatory Oversight
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
Quality Control Laboratory Compliance - cGMPs and GLPs>
Latin America: Regulatory Compliance Requirements for Life Science Products ...
FDA's New Import Program for 2018 - Strict Precision
Fostering Employee Engagement
Best in Class Wage & Hour Compliance: The Federal Labor Standards Act (FLSA)
A+ PHR/SPHR/PHRca Certification Review Program
Roadmap of California Medical Leaves - Ultimate Guide to PDL, FMLA, FEHA, SDI ...
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Managing Your FDA Inspection: Before, During and After
21 CFR Part 820 Quality System Regulation and FDA cGMP Requirements for Med ...
Data Integrity and Good Documentation Practices
Principles and Application of Hazard Analysis Critical Control Point (HACCP)
FDA Regulations for Dietary Supplements Manufacturers (21 CFR Part 111, GMP ...
Implementing the New Australian Standard for Product Recall
REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tis ...
Business Continuity Auditing Plans Using ISO 22301
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› Clinical Compliance
Clinical Research Regulations Training, Compliance Best Practices and Standards
Clinical trial regulations based webinars, in-person seminars, standards and best practices. Learn from renowned experts about FDA and ICH clinical trial regulations and guidelines – ICH GCP guidelines, Patient Safety, Regulatory filings, Fraud and misconduct, Warning letters and 483s, FDA clinical trial audit, etc.

Clinical Research Regulations Training
Good Clinical Practice (GCP) compliance training educates employees on best practices to comply with ICH-GCP guidelines. The responsibility to ensure compliance with GCP guidelines is shared by all the parties involved in conducting clinical trials. Consequently GCP training has become essential for all professionals involved in the planning, executing, monitoring, documenting, auditing, and reporting of clinical research to better understand its regulatory requirements. GMP training will also provide insight on common pitfalls identified during clinical investigations and how to avoid them.
GCP compliance assures that right, safety and well-being of trial subjects are protected and that the trial data are accurate and reliable. Failure to comply with GCP regulations can lead to hefty fines, debarment, damage to institutional reputation and even imprisonment. In one of the most recent cases, an European regulator has banned the sale of drugs approved on the basis of clinical trials conducted at GVK Biosciences India due to the plant’s non-compliance with GCP guidelines.
Good Clinical Practice is an international quality standard for conducting clinical trials that involves human subjects. GCP guidelines include standards for designing, conducting, recording and reporting of clinical trials. GCP guidelines also define the roles and responsibilities of ethics committee, clinical research sponsors and investigators.
ComplianceOnline GCP Training Courses
GCP compliance can be multi-faceted and complex depending on your operations. An effective training program will consider current trends and requirements, bringing you the latest updates from experienced instructors. ComplianceOnline offers GCP compliance training programs in various formats, including: live webinars, training recordings, in-person seminars, and customised organization-level in-person seminars. Led by recognized experts and industry veterans with decades of experience in regulatory affairs and compliance, our training programs will offer staff and management an interactive platform to understand and discuss current industry standards.
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