Pharmaceutical Management and Regulatory Compliance Training Course

Course Outline

Module 1: Foundations of Pharmaceutical Management

ü  The unique landscape of the pharmaceutical industry

ü  The product lifecycle from R&D to market

ü  Key roles and responsibilities in a pharmaceutical company

ü  The importance of ethics and integrity

ü  Practical Session: Identifying Key Stakeholders and Their Roles

Module 2: Good Manufacturing Practices (GMP)

ü  Core principles of GMP and its application

ü  Facility and equipment requirements

ü  Personnel and training standards

ü  Aseptic processing and contamination control

ü  Practical Session: Conducting a GMP Facility Walkthrough Simulation

Module 3: Good Distribution Practices (GDP) and Supply Chain

ü  The importance of cold chain management

ü  Ensuring product integrity during transport

ü  Handling of returns and recalls

ü  The role of security and anti-counterfeiting measures

ü  Practical Session: Mapping a Secure Pharmaceutical Supply Chain

Module 4: Quality Management Systems (QMS)

ü  Key elements of a robust QMS

ü  Document control and record management

ü  Deviation and change control

ü  Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA)

ü  Practical Session: Drafting a CAPA Plan for a Non-Compliance Incident

Module 5: Pharmaceutical Regulatory Affairs

ü  Navigating major regulatory bodies (FDA, EMA, WHO)

ü  The drug approval process

ü  Post-market surveillance and life-cycle management

ü  Global harmonization efforts and trends

ü  Practical Session: Analyzing a Regulatory Submission Case Study

Module 6: Auditing and Inspections

ü  Types of audits: internal, external, and regulatory

ü  Preparing for a regulatory inspection

ü  Best practices for hosting inspectors

ü  The post-inspection response and follow-up

ü  Practical Session: Role-Playing a Mock Regulatory Inspection

Module 7: Pharmacovigilance and Safety Reporting

ü  The importance of pharmacovigilance (PV)

ü  Adverse event reporting and data collection

ü  Signal detection and risk assessment

ü  The role of PV in patient safety

ü  Practical Session: Completing an Adverse Event Report

Module 8: Risk Management in Pharmaceuticals

ü  Applying a risk-based approach to all operations

ü  Risk assessment tools and methodologies

ü  Mitigating risks related to quality and compliance

ü  Integrating risk management into the QMS

ü  Practical Session: Conducting a Risk Assessment on a New Product Launch

Module 9: Data Integrity and Documentation

ü  The critical importance of data integrity

ü  ALCOA+ principles

ü  Electronic records and e-signatures

ü  Avoiding common documentation errors

ü  Practical Session: Auditing a Batch Record for Data Integrity Issues

Module 10: The Certified Manager Capstone Project

ü  Participants will be given a complex management challenge

ü  Independently develop a comprehensive compliance strategy

ü  Present their findings and recommendations

ü  Receive final feedback and certification

ü  Practical Session: Presenting a Strategic Compliance Plan

About Our Trainers

Our trainers are highly experienced pharmaceutical professionals with over 15 years in quality assurance, regulatory affairs, and operations management. They have held leadership positions in multinational pharmaceutical companies and have successfully guided organizations through complex regulatory audits. Their expertise is both academic and practical, ensuring participants gain real-world knowledge that can be immediately applied.

Quality Statement

We are committed to delivering a superior training experience. Our pharmaceutical compliance training courses feature a meticulously designed curriculum, expert instruction, and a hands-on approach to ensure you leave with tangible, applicable skills. Our commitment to quality in our pharmaceutical management and compliance training courses ensures your professional development is an excellent investment.

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

1. Discounts: Organizations sponsoring Four Participants will have the 5th attend Free
2. 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.
3. Certificate Awarded: Participants are awarded Certificates of Participation at the end of the training.
4. The program content shown here is for guidance purposes only. Our continuous course improvement process may lead to changes in topics and course structure.
5. 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:

1. 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.
2. Invoice: We can send a bill directly to you or your company.
3. Deposit directly into Bank Account (Account details provided upon request)

Cancellation Policy

1. Payment for all courses includes a registration fee, which is non-refundable, and equals 15% of the total sum of the course fee.
2. Participants may cancel attendance 14 days or more prior to the training commencement date.
3. 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.

Tailor-Made Courses

We understand that every organization has unique challenges and opportunities as well as unique training needs. Phoenix Training Center offers tailor-made courses designed to address specific requirements and challenges faced by your team or organization. Whether you need a customized curriculum, a specific duration, or on-site delivery, we can adapt our expertise to provide a training solution that perfectly aligns with your objectives. We can customize this Course to focus on your industry, specific risk profile, or internal stakeholder dynamics. Contact us to discuss how we can create a bespoke training program that maximizes value and impact for your team. For further inquiries, please contact us on Tel: +254720272325 / +254737296202 or Email training@phoenixtrainingcenter.com

Accommodation and Airport Pick-up

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