PharSafer Associates Ltd’s Post

Less than 8 weeks left in 2024! Do you have team members who need intensive or advanced GMP compliance training to fulfil their new job roles or to maintain GMP training compliance? Train your team with PharmOut's Certificate GMP/GxP courses via ZOOM. https://lnkd.in/gsifTTf Delivered virtually, these 1-day intensive training courses are perfect for pharmaceutical, life sciences and validation professionals who need impactful training that fits into their busy schedules. Attend from anywhere with your pc/laptop or computer, the Zoom app, and a steady internet connection! ✅ Why Attend? Focused Learning: Deep dive into specific GMP topics in a single day, making it efficient and impactful. Industry Experts: Learn from seasoned professionals who bring real-world insights and practical examples. Convenient & Interactive: Join from anywhere via ZOOM, and actively engage with our industry experts, and connect with peers in the industry. Whether you're looking to refresh your knowledge or advance your career, our 1-day intensive courses provide everything you need to stay compliant and competitive in your career! Don’t miss out on your chance to get ahead, and get those GMP/GxP training certificates in your personnel files before your next GMP compliance audit! #pharmanews #validation #pharma #pharmajobs #gmptraining #tga #audit #exports

Are you a Professional involved in the planning, preparation, coordination, and review of aggregated safety reports? 👇 take a look at these two interesting training opportunities 𝗧𝗵𝗲 𝗣𝗦𝗠𝗙 (𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝘃𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 𝗦𝘆𝘀𝘁𝗲𝗺 𝗠𝗮𝘀𝘁𝗲𝗿 𝗙𝗶𝗹𝗲): 𝗳𝗿𝗼𝗺 𝗚𝗩𝗣𝘀 𝘁𝗼 𝗜𝗻𝘀𝗽𝗲𝗰𝘁𝗶𝗼𝗻𝘀 To ensure compliance, this training will provide practical guidance to developing, drafting, maintaining, and updating the PSMF. The sessions will also discuss the PSMF's importance in regulatory inspections, as well as common PSMF inspection findings. 🗓️ 14 and 21 June 2024 | online 👉 https://lnkd.in/ef7S5pMB 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐨𝐯𝐢𝐠𝐢𝐥𝐚𝐧𝐜𝐞 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐋𝐢𝐟𝐞 𝐂𝐲𝐜𝐥𝐞 𝐨𝐟 𝐚 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐚𝐥 𝐏𝐫𝐨𝐝𝐮𝐜𝐭 This training path in 6 modules (total 24 hours) of highly interactive online training is designed to give an extensive overview of the pharmacovigilance activities and the related documents throughout the life cycle of a medicinal product. We will address: -benefit-risk analysis -signal management -data collection process -consolidated documents in the different phases of the life cycle -structure and content of consolidated documents -similarities, differences and synergies among the various documents 🗓️From 18 September to 23 October 2024 / online 👉https://lnkd.in/e23kAaeP #LSAcademy #pharmacovigilance #training

Potent drug / HPAPI Safety Training. Potent and highly potent API (HPAPI) occupational health and safety presents the most complicated H&S management challenge in industry. Engineering controls/containment should form the main pillar of worker protection, but workers’ actions, related procedures (SOPs) and management effectiveness more widely, are just as important. HPAPI Project Services offers customised, multi-discipline potent drug safety training, delivered to different worker groups (operators, lab staff, engineers, management teams and more). Multiple sessions can be delivered sequentially, to accommodate complete company teams, including capturing different shifts. Active pharmaceutical ingredients (APIs) present hazards and risks far higher than ‘regular’ hazardous substances such as toxic/hazardous gases and solvents. Company and worker potent drug safety awareness is critical to effective API processing and project design. Contact HPAPI Project Services to enquire about potent drug safety training for your teams. ·        Operators ·        Lab staff ·        Engineers ·        Management staff

Most Common GMP Deficiencies of Local Pharma Industries (Part-II): 4. PERSONNEL: - Newly recruited staff not getting adequate induction GMP training and specialized training. - On-job refreshment training is insuffient. Inadequate basic training: basics of GMP, Hygiene & Sanitation, Safety, entry/exit procedures. - No evaluation of in-service training: Operating instruction of production machines, Job related Training (SOPs Training), maintenance of BMRs and GLP training. - Inadequate Personnel hygiene procedures and facilities. 5. EQUIPMENT: - Poor documentation (URS, Specifications) - No or inadequate qualification - No planned preventive maintenance programme. - No cleaning procedures or not adequately validated or executed. - The maximum holding time of dirty equipment before cleaning was not defined. - The qualification status of equipment and utilities was not defined. 6. MATERIALS: - Raw materials being not Pharmaceutical grade were used for pharmaceutical manufacturing. - Materials were found not being labeled with their manufacturing stages. - The sampling plan did not define sampling methods, labeling and storage of samples. - Standards were not assigned expiry dates after opening. 7. SAMPLING AND DISPENSING: - No zone concept existed for the sampling area. - No material airlock existed for the sampling area. - No procedure for handling of spillages existed in the sampling and dispensing. 8. QUALITY CONTROL: - Contradicting data were observed in worksheet and workbook. - There is no defined procedures how samples are coming from production and warehouse for testing. - Detail of material and equipments used during the test was not recorded. - Calculations of values were made by hand and formulas were not validated. - Test samples in the stability chamber was stored so congested that can alter the free flow of air that can compromise on the validity of the test result. - No samples are retained or in appropriately stored. 9. HEATING, VENTILATION AND AIR CONDITIONING (HVAC): - Specifications of primary and secondary filters were unknown. - Pressure drops over primary and secondary filters were not monitored. - No preventive maintenance existed for the air handling system. - No schedule for filter cleaning existed. - Air flow directions were not indicated. 10. ENVIRONMENTAL MONITORING: - No action and alert limits were defined for particle counts and microbial load. - Routine monitoring of micro-organisms and particle counts was done using a reduced number of sampling positions. - No annual environmental monitoring reports were prepared. - No environmental monitoring was performed in areas for manufacture of non-sterile products.

GMP Training Concept of GMP is embedded in “P” which means Practice and when we prefix “c” to GMP, it becomes Current, Continuous and Compliance. GMP Training is a Continuous process to meet Current regulations so as all Ps (Personnel, Premises, Process, Production and Product) are in compliance. Any misunderstanding can lead to loss of profit and pay package Training is essential for establishing a GMP-compliant culture. Q. Now question arises, who should be trained and by whom? Ans: Everyone involved in the Pharmaceuticals Business must undergo relevant training for the part of operation S/He is responsible and which affect directly or in-directly other functions. Training should be imparted by person having adequate expertise, experience and trained in relevant field. Q. What should be the frequency of training? Ans: Regulatory Authorities expect personnel to receive ongoing (repeated) training in essential GMP/GxP compliance topics. GMP Education Programs for new employees generally include: An overview of the company’s history, Broad Organisation structure and Department organogram Therapy product lines Role responsibilities direct and Cross-functional Documentation procedures Department specific SOPs Product/ process specific training Personnel hygiene & safety training Repetition in Learning is very important and this should not be ignored by the Organisation. Why? Repetition plays a pivotal role in knowledge retention and skill acquisition. In a pharmaceutical manufacturing facility, however, repetition in learning is essential and expected by most of the Regulatory Agencies. Organisations must provide timely and documented training for all impacted personnel whenever: A procedure is updated GMP guideline is updated An event or incident occurs which could impact product quality or patient safety CAPA is implemented Q. What are the Options for GMP Education Programs? Ans: Initial and Regular GMP training may involve onsite training sessions, offsite GMP workshops and On-line video media. Whatever is the mode of training, at the end of session, there should be some type of Assessment of both the trainer and trainee and also a “Certificate for Completion of GMP course” should be issued by the Trainer for record. Contact us today to know more about our customised Training solutions on +91-9324052308 or write to us at [email protected]

# 10 Tips to Succeed in Personnel Qualifications According to EU GMP Are you looking to ensure your team meets EU GMP standards for personnel qualifications? Here are 10 essential tips to help you succeed: 1. Establish a Robust Training Program**: Develop a comprehensive training system that covers all aspects of GMP relevant to each employee's role. 2. Document Everything**: Maintain detailed records of all training activities, qualifications, and assessments. Remember, if it's not documented, it didn't happen! 3. Implement Continuous Education**: GMP is always evolving. Ensure your team stays up-to-date with regular refresher courses and updates on new regulations. 4. Conduct Regular Assessments**: Periodically evaluate your staff's knowledge and skills to identify any gaps that need addressing. 5. Tailor Training to Job Functions**: Ensure each employee receives training specific to their role and responsibilities within the GMP environment. 6. Emphasize the Importance of Quality Culture**: Foster a workplace culture where quality is everyone's responsibility, not just the QA department's. 7. Utilize Various Training Methods**: Incorporate different learning approaches such as classroom sessions, on-the-job training, and e-learning to cater to different learning styles. 8. Verify Competency**: Don't just train - ensure employees can demonstrate their ability to apply GMP principles in their daily work. 9. Encourage Cross-Training**: This not only enhances flexibility but also deepens understanding of GMP across different areas of operation. 10. Stay Audit-Ready**: Regularly review and update your qualification processes to ensure they meet the latest EU GMP guidelines and are always prepared for inspections. Remember, investing in your team's GMP qualifications is investing in the quality and compliance of your products. What strategies have you found effective in your GMP training programs? Share your thoughts in the comments! #EUGMP #PersonnelQualification #PharmaceuticalCompliance #QualityAssurance #ContinuousImprovement #MEVAC MEVAC for Vaccines

Annual Pharmacovigilance refresher training>> conducted with success✅️ Pharmacovigilance refresher training holds immense significance in the healthcare industry, particularly for professionals involved in drug safety monitoring. 🔬 This training serves as a crucial tool to ensure that practitioners remain up-to-date with the latest advancements, guidelines, and best practices in the field. It reinforces their knowledge and skills in detecting, reporting, and analyzing adverse drug reactions, thereby contributing to the overall safety and efficacy of medications. Moreover, regular refresher courses foster a culture of continuous learning, enabling pharmacovigilance experts to adapt to the dynamic regulatory requirements. ✔️ By promoting a higher level of competence and vigilance, pharmacovigilance refresher training plays a vital role in safeguarding public health and maintaining trust in the pharmaceutical industry.🫡

cGMP Training  Last week, Scientech conducted an intensive cGMP (current Good Manufacturing Practice) training session for our employees, underscoring our commitment to upholding the highest standards in our laboratory operations and work processes. This training is crucial for ensuring product quality, data integrity, and regulatory compliance. The cGMP training reinforced our dedication to excellence and continuous improvement in all our operations. By equipping our team with the latest knowledge and skills, we ensure that Scientech remains a leader in quality and FDA compliance. This training is part of our ongoing effort to foster a culture where every employee understands their role in maintaining the highest standards. Fire Safety Training At Scientech, employee safety is our top priority. Recently, we conducted a comprehensive fire safety training session to ensure our team is well-prepared to handle fire emergencies. Understanding fire hazards and knowing how to respond effectively can save lives and minimize property damage. Our training aimed to instill this knowledge and preparedness in our employees while creating a culture of vigilance and proactive hazard management. We believe safety is a shared responsibility here at Scientech which is why we continue to practice open communication about safety concerns and continuous learning.

As much as I like to emphasize the famous quote "learning never stops," I can confidently say that my learning journey has been consistent at my current workplace due to various trainings I have been privileged to attend and gain knowledge from, both internally and externally.  Internally, I have benefited from departmental-level trainings such as Quality Assurance (#QA) Monthly trainings and special trainings like WHO-Good Practices for Pharmaceutical Quality Control Laboratories (#WHO-GPPQCL), Dossier preparation, Contamination Control Strategy (#CCS), Good Manufacturing Practices (#GMP), Good Laboratory Practices (#GLP), Good Documentation Practices (#GDP), and Ergonomics. Externally, I have attended trainings like Utilization of ODOO in sterile pharmaceutical industry at HMA 1 (needle and syringe plant) and webinars like Week of #Quality for Medicines 2024: Driving Quality Forward - A workshop for pharmaceutical manufacturers, among many others that I would like to reference. Today, at HMA 2 (#IVF plant), my colleagues and I were given the opportunity by the board and management to gain further insight into basic first aid and occupational #health and #safety, conducted by Industrial Training Funds (ITF) Ilorin. It was an eye-opener, and I was enlightened on safety protocols, hazard identification, emergency response, incident reporting, cardiopulmonary resuscitation (CPR), automatic external defibrillator (AED), and first aid kits, among many other important terminologies. In conclusion, my learning journey has been a continuous and enriching #experience, thanks to the various trainings and opportunities I've had at my #workplace. From enhancing my knowledge of #pharmaceutical #quality #control to gaining practical insights into #occupational #health and #safety, I have become a more #confident and #competent #professional. I am grateful for the support of my organization and the expertise of the trainers, and I look forward to applying my newfound skills and knowledge to drive excellence in my work. As I reflect on the quote "learning never stops," I am reminded that there is always room for #growth and #improvement, and I am excited to see where my future #learning journey takes me.

Who hasn't heard of the Chernobyl nuclear disaster of 1986? It showed us the dangers of equipment failure due to poor maintenance and human errors. Similarly, in the pharmaceutical industry, keeping equipment in top shape is essential not only for accurate results but also to prevent mishaps. Follow simple steps that we have laid out in our module to achieve compliance, safety, and accurate results.