contact@hcspharma.com

Training

HCS offers training topics related to the pharmaceutical industry. HCS also assists companies in the design of their training programs and in the follow-up for the submission and reimbursement of training files. HCS offers two types of training:

Face to face training

  • Inter-company.
  • Intra-company.

Tele-training

  • Virtual class.
  • E-learning.

Our trainings

Regulatory affaires

T-RA-01

Stability study: Regulatory and practical issues

T-RA-02

ICH Q3D and elemental impurities: risk analysis and control strategy

T-RA-03

Regulatory compliance of pharmaceutical products: ICH Q12

T-RA-04

Bioequivalence: concept, method of exploration and applications

T-RA-05

Transposition and industrial transfer: mastering your industrial transfers

T-RA-06

The CTD and the pharmaceutical dossier: mastering the preparation of the CTD quality module Workshop: writing module 3 of the CTD dossier for a chemical drug

T-RA-07

The MA dossier for a generic drug: studies and preparation of files for registration in Morocco and abroad

T-RA-08

Regulatory affairs in pharmaceutical companies, medical devices, food supplements, cosmetics

T-RA-09

Site Master File

T-RA-10

Impurities in pharmaceutical products: active ingredients and finished products

T-RA-11

Active pharmaceutical ingredients: DMF and CEP

T-RA-12

Pharmaceutical variations in the MA file

Quality and quality assurance

T-QA-01

Approval for suppliers of raw materials: active ingredients, excipients, primary and printed packaging materials

T-QA-02

Supplier Audit

T-QA-03

Quality audit (Internal and external) according to ICH Q10

T-QA-04

Good documentation practices

T-QA-05

Good Manufacturing Practices - Current version

T-QA-06

Process mapping and management

T-QA-07

Design and review of batch records (BMR)

T-QA-08

Supplier quality agreement

T-QA-09

CAPA Management

T-QA-10

Change control management

T-QA-11

Deviation Management

T-QA-12

OOS/OOT management

T-QA-13

HVAC- Clean Room (from consultation to qualification)

T-QA-14

ICH Q10 - Pharmaceutical Quality System

T-QA-15

Transposition and industrial transfer: mastering your industrial transfers

T-QA-16

Validation of cleaning processes in the pharmaceutical and related industries

T-QA-17

Lean Management

T-QA-18

GMP for manufacturing personnel

T-QA-19

GMP for maintenance personnel

T-QA-20

GMP for quality control laboratories personnel

T-QA-21

GMP for Warehouse personnel

T-QA-22

Risk management and ICH Q9

T-QA-23

Periodic requalification of air handling systems for controlled dust areas in aseptic production

T-QA-24

Pharmaceutical gas system

T-QA-25

Annual Product Review (APR or PQR)

T-QA-26

Validations and qualifications in the pharmaceutical and related industries

Analytical Development and QC

T-QC-01

Good sampling practices for material flows in pharmaceutical production

T-QC-02

Microbiological control

T-QC-03

Water for pharmaceutical use: Analytical monitoring of water

T-QC-04

Stability study

T-QC-05

ICH Q3D and elemental impurities: risk analysis and control strategy

T-QC-06

The establishment of specifications for a pharmaceutical product and their evolution during development

T-QC-07

The metrology function in the pharmaceutical industry

T-QC-08

Validation of analytical methods

T-QC-09

Analytical development in the pharmaceutical industry

T-QC-10

Transfer of analytical methods: knowledge and management of associated risks: methodologies and statistical strategies to reduce these risks

T-QC-11

Environmental controls in cleanrooms. Physical and microbiological controls in cleanrooms

T-QC-12

Pharmaceutical gases: from sampling to analytical monitoring

T-QC-13

Impurities in pharmaceutical products: active ingredients and finished products: regulations, specifications and analytical aspects

T-QC-14

Quality of the active pharmaceutical ingredients: DMF and CEP

T-QC-15

Periodic requalification of air handling systems for dust-controlled areas in aseptic production

Production and Galenic Development

T-PD-01

Industrial compression: understanding and controlling the process

T-PD-02

Design and review of batch records

T-PD-03

Conducting the activities of a Dispensing unit

T-PD-04

Operate a packaging line

T-PD-05

Galenic development of solid oral forms: pre-formulation, formulation, process study

T-PD-06

Non-sterile liquid forms Manufacture

T-PD-07

Holding time for intermediate and bulk products

T-PD-08

Introduction to the galenic development of a drug: study of the different phases from pre-formulation to industrial transposition

T-PD-09

Statistical Process Control (SPC)

T-PD-10

Manage autoclaving operations

T-PD-11

Control and supervise the main granulation processes (wet and/or dry)

T-PD-12

To control the manufacturing processes of injectable products

T-PD-13

Qualification of pharmaceutical production equipment

T-PD-14

Transposition and industrial transfer

T-PD-15

Manufacturing Troubleshooting

T-PD-16

Validation of aseptic manufacturing processes in the pharmaceutical industry

T-PD-17

Validation of manufacturing processes in the pharmaceutical industry

T-PD-18

Validations and qualifications in the pharmaceutical industry