Peak Pharmaceutical Organization FDA Audit Knowledge Training
Release time:
2023-02-22
News from our newspaper In order to improve the understanding of FDA certification and prepare for the certification of international projects, # June 14 and 16 , Jianfeng Pharmaceutical Company specially organized the manufacturing department 2 to carry out FDA audit process sorting and simulated audit question and answer sharing training.
This sharing was given by Wang Bihu, Quality Director of Jianfeng Pharmaceutical. He took the FDA audit inspection of foreign enterprise products as a case and clearly and detailedly showed the whole staff the 5 -day audit inspection process and the events that occurred in the process. He also put forward audit questions from the auditor's perspective, such as closed, open, I don't understand, theoretical, silent question, I am an expert, etc., so that the trainees can further understand how to make the best response when being asked in different situations.
Vivid sharing training, so that employees understand that in the inspection process, they should pay special attention to their own job cognition, do not make subjective guesses and judgments, keep the content of the answers before and after, and do not need to be overly nervous. They should be based on the content specified in SOP and SMP procedures and calmly deal with the audit inspection. This training has strengthened employees' awareness of the FDA inspection and enhanced their confidence in winning the inspection. (Li Beibei)
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The company requires to do a good job in summer safety production
The high temperature season is approaching, and the group company issued a notice a few days ago to make arrangements for safe production in summer. The notice requires all subordinate units of the company to attach great importance to the work of production safety in summer, and all production and business units should hold a special meeting on production safety in summer. According to the characteristics of production in summer, they should focus on safety risk analysis for mines, outdoor operations and high-temperature posts, and implement control measures to avoid the occurrence of safety accidents such as scalding, heatstroke and electric shock. In order to further strengthen the safety production management in the high temperature season, the notice requires the main person in charge of each production and business unit to lead a team to conduct a comprehensive inspection of the production and business premises according to the characteristics of summer production; strengthen the daily safety production inspection of key posts and special posts; timely rectify the found unsafe behaviors and hidden dangers; Strengthen the management of the storage and use of flammable, explosive, dangerous chemicals and drugs; cooling measures shall be taken for the space exceeding the storage temperature limit of articles. If it is found that the electrical equipment circuit and exhaust fan circuit are aged and damaged, replace them in time and keep the grounding wire in good condition. Do a good job in checking the fire pool, pipeline water pressure and fire extinguishing equipment to ensure that the fire fighting facilities are sensitive, intact and reliable. The high temperature in summer is also a period of frequent occurrence of heatstroke and other diseases. The notice requires all units to do a good job in heatstroke prevention and cooling, implement various relevant measures, and equip necessary cooling facilities or materials such as fans, air conditioners, ice cubes and other cooling facilities or materials according to the conditions of the production site; do a good job in the distribution of heatstroke prevention drugs, supplies and cool drinks in workshops, warehouses, construction sites and other production lines; strengthen canteen management to prevent food poisoning. (this newspaper reporter)
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The company requires to do a good job in summer safety production
The high temperature season is approaching, and the group company issued a notice a few days ago to make arrangements for safe production in summer. The notice requires all subordinate units of the company to attach great importance to the work of production safety in summer, and all production and business units should hold a special meeting on production safety in summer. According to the characteristics of production in summer, they should focus on safety risk analysis for mines, outdoor operations and high-temperature posts, and implement control measures to avoid the occurrence of safety accidents such as scalding, heatstroke and electric shock. In order to further strengthen the safety production management in the high temperature season, the notice requires the main person in charge of each production and business unit to lead a team to conduct a comprehensive inspection of the production and business premises according to the characteristics of summer production; strengthen the daily safety production inspection of key posts and special posts; timely rectify the found unsafe behaviors and hidden dangers; Strengthen the management of the storage and use of flammable, explosive, dangerous chemicals and drugs; cooling measures shall be taken for the space exceeding the storage temperature limit of articles. If it is found that the electrical equipment circuit and exhaust fan circuit are aged and damaged, replace them in time and keep the grounding wire in good condition. Do a good job in checking the fire pool, pipeline water pressure and fire extinguishing equipment to ensure that the fire fighting facilities are sensitive, intact and reliable. The high temperature in summer is also a period of frequent occurrence of heatstroke and other diseases. The notice requires all units to do a good job in heatstroke prevention and cooling, implement various relevant measures, and equip necessary cooling facilities or materials such as fans, air conditioners, ice cubes and other cooling facilities or materials according to the conditions of the production site; do a good job in the distribution of heatstroke prevention drugs, supplies and cool drinks in workshops, warehouses, construction sites and other production lines; strengthen canteen management to prevent food poisoning. (this newspaper reporter)
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