📜 Certified Pharmaceutical Compliance Officer (CPCO) Training Program

Module 1: Global Pharmaceutical Regulatory Frameworks and Compliance Overview

 

ü  Key global regulatory bodies (FDA, EMA, WHO, ICH)

ü  The role of the Compliance Officer and the compliance function

ü  Elements of an effective pharmaceutical compliance training programs

ü  Overview of the drug lifecycle and associated regulatory milestones

ü  Consequences of non-compliance (fines, Warning Letters, debarment)

ü  Practical Session: Analyzing and interpreting key sections of a global regulatory guidance document

 

Module 2: Good Manufacturing Practice (GMP) and Quality Management Systems (QMS)

 

ü  Detailed review of GMP regulations (e.g., 21 CFR Part 210/211)

ü  Structure and documentation of the Quality Management System (QMS)

ü  Deviation, CAPA (Corrective and Preventive Action), and Change Control processes

ü  Managing critical utilities (HVAC, Water Systems) compliance

ü  Ensuring material control and traceability

ü  Practical Session: Developing a CAPA plan based on a simulated manufacturing deviation

 

Module 3: Data Integrity, Validation, and Electronic Records Compliance

 

ü  Principles of Data Integrity (ALCOA+ standard)

ü  Regulatory requirements for computer system Validation

ü  Compliance with 21 CFR Part 11 (Electronic Records and Signatures)

ü  Audit trails, security, and data governance policies

ü  Best practices for managing raw data and source documentation

ü  Practical Session: Reviewing a validation summary report for compliance completeness

 

Module 4: Clinical Trials and Pharmacovigilance Compliance

 

ü  Adherence to Good Clinical Practice (GCP) principles

ü  Informed consent, patient safety, and Institutional Review Boards (IRBs)

ü  Regulations governing Pharmacovigilance (safety reporting and surveillance)

ü  Managing clinical trial documentation and trial master files (TMF)

ü  Data privacy considerations in clinical research

ü  Practical Session: Identifying and reporting a simulated adverse event in a clinical trial scenario

 

Module 5: Marketing, Promotion, and Anti-Kickback/Anti-Corruption Laws

 

ü  Compliance with regulations governing drug promotion and advertising

ü  US Anti-Kickback Statute and similar global laws

ü  FCPA (Foreign Corrupt Practices Act) and global Anti-Bribery compliance

ü  Interactions with healthcare professionals (HCPs) and transparency reporting

ü  Ethics in drug pricing and market access

ü  Practical Session: Analyzing a promotional piece for compliance with labeling requirements and anti-kickback risks

 

Module 6: Privacy Regulations: GDPR, HIPAA, and Patient Data Protection

 

ü  HIPAA compliance requirements for protected health information (PHI)

ü  GDPR and global data privacy standards for patient data

ü  Developing policies for data handling, storage, and cross-border transfer

ü  Managing data breaches and mandatory reporting

ü  The intersection of compliance and cybersecurity

ü  Practical Session: Developing an internal checklist for HIPAA/GDPR-compliant handling of patient data

 

Module 7: Designing and Implementing Pharmaceutical Compliance Training Programs

 

ü  Needs assessment and gap analysis for compliance training

ü  Structuring effective pharmaceutical compliance training modules and content delivery

ü  Utilizing different training formats (LMS, in-person, micro-learning)

ü  Measuring training effectiveness and ensuring documented completion

ü  Making pharmaceutical compliance training modules engaging and relevant

ü  Practical Session: Designing the syllabus and content outline for a new employee Code of Conduct module

 

Module 8: Conducting Internal Audits and Managing Regulatory Inspections

 

ü  Planning and executing risk-based Internal Audits

ü  Audit methodology, reporting findings, and tracking CAPA effectiveness

ü  Preparing the site and personnel for Regulatory Inspections (FDA, EMA)

ü  Best practices for handling questions and documentation during an inspection

ü  Developing effective responses to inspection findings (Form 483, Warning Letters)

ü  Practical Session: Role-Playing a Mock Regulatory Inspection Interview

 

Module 9: Vendor and Third-Party Compliance Management

 

ü  Due diligence and risk assessment for contract manufacturing organizations (CMOs) and vendors

ü  Quality Agreements and defining compliance responsibilities

ü  Monitoring and auditing vendor compliance throughout the lifecycle

ü  Managing outsourced activities (e.g., distribution, laboratory services)

ü  Addressing third-party compliance failures

ü  Practical Session: Reviewing and commenting on a draft Quality Agreement with a CMO

 

Module 10: Compliance Culture, Ethics, and Whistleblower Protection

 

ü  Building and sustaining an ethical Compliance Culture

ü  Developing and enforcing the organizational Code of Conduct

ü  Establishing effective reporting mechanisms and Whistleblower Protection

ü  Investigative procedures for compliance violations

ü  Role of leadership in championing ethical behavior

ü  Practical Session: Analyzing a scenario involving a potential ethics violation and outlining investigation steps

About Our Trainers

 

Our trainers are certified compliance and quality professionals, including former FDA/EMA regulatory inspectors, Chief Compliance Officers (CCOs), and corporate counsels from major pharmaceutical companies. They have an average of 20 years of experience successfully designing pharmaceutical compliance training programs, navigating complex international audits, and ensuring adherence to GMP and anti-corruption laws. Their real-world expertise in creating and managing effective pharmaceutical compliance training modules is invaluable.

 

Quality Statement

 

We are committed to delivering the highest caliber of professional education. Our pharmaceutical compliance training programs are continuously updated to reflect the latest regulatory guidances, enforcement trends (FDA Warning Letters), and legal precedents. We ensure a highly interactive and practical learning environment focused on developing actionable skills in compliance management and the creation of effective pharmaceutical compliance training modules.

 

Tailor-Made Courses

We offer tailor-made courses that can be customized to your company's specific product focus (e.g., medical devices, biologics), geographic markets (e.g., US/EU focus), or functional requirements (e.g., deep dive on GMP or Clinical Trial Compliance). We can adjust content, duration, and delivery (in-house, on-site, or virtual) to align with your organization's internal compliance structure and existing pharmaceutical compliance training programs. For further inquiries, please contact us on Tel: +254720272325 / +254737296202 or Email training@phoenixtrainingcenter.com

Admission Criteria

ü  Participants should be reasonably proficient in English. 

ü  Applicants must live up to Phoenix Center for Policy, Research and Training admission criteria.

Terms and Conditions

ü  Discounts: Organizations sponsoring Four Participants will have the 5th attend Free

ü  What is catered for by the Course Fees: Fees cater for all requirements for the training – Learning materials, Lunches, Teas, Snacks and Certification. All participants will additionally cater for their travel and accommodation expenses, visa application, insurance, and other personal expenses.

ü  Certificate Awarded: Participants are awarded Certificates of Participation at the end of the training.

ü  The program content shown here is for guidance purposes only. Our continuous course improvement process may lead to changes in topics and course structure.

ü  Approval of Course: Our Programs are NITA Approved. Participating organizations can therefore claim reimbursement on fees paid in accordance with NITA Rules.

Booking for Training

Simply send an email to the Training Officer on training@phoenixtrainingcenter.com and we will send you a registration form. We advise you to book early to avoid missing a seat to this training. Or call us on +254720272325 / +254737296202

Payment Options

We provide 3 payment options, choose one for your convenience, and kindly make payments at least 5 days before the Training start date to reserve your seat:

ü  Groups of 5 People and Above – Cheque Payments to: Phoenix Center for Policy, Research and Training Limited should be paid in advance, 5 days to the training.

ü  Invoice: We can send a bill directly to you or your company.

ü  Deposit directly into Bank Account (Account details provided upon request)

Cancellation Policy

ü  Payment for all courses includes a registration fee, which is non-refundable, and equals 15% of the total sum of the course fee.

ü  Participants may cancel attendance 14 days or more prior to the training commencement date.

ü  No refunds will be made 14 days or less before the training commencement date. However, participants who are unable to attend may opt to attend a similar training course at a later date or send a substitute participant provided the participation criteria have been met.

Accommodation and Airport Transfer

For physical training attendees, we can assist with recommendations for accommodation near the training venue. Airport pick-up services can also be arranged upon request to ensure a smooth arrival. Please inform us of your travel details in advance if you require these services. For reservations contact the Training Officer on Email: training@phoenixtrainingcenter.com or on Tel: +254720272325 / +254737296202